NIH Says No, and Also No

noWith no announcement or fanfare, the CFS Advisory Committee has posted a response from HHS to the June 2014 recommendations. My information is that  – inexplicably – even CFSAC members were not notified when the response was posted. I urge you to read the entire response, but I am going to focus on just a few sentences. There are very serious implications for the future of ME/CFS research, but despite NIH’s entrenched position, there are still things we can do about it.

No Data Sharing Platform For You

The first recommendation was that NIH create and maintain a data sharing platform for ME/CFS research. NIH’s response? No. But their reasoning is remarkable:

[D]eveloping and maintaining a unique ME/CFS database is cost prohibitive in light of the small number of researchers . . . the cost of developing and maintaining an ME/CFS database would significantly reduce funds available for funding research on ME/CFS . . .

Translation: There are not enough of you to make this platform idea worth the money.

But the implication of that last sentence is astounding: maintaining such a database would reduce the funds available for research. Translation: NIH will only spend a fixed amount of money on ME/CFS. Even if NIH decided to create a database, there would be no increase in funds to cover the cost – that money would simply be reallocated from grants.

The background document to the recommendation specifically states that a central data sharing platform would “greatly accelerate research discovery” and foster “opportunities for new scientists to enter the field.” The platform would lower barriers to conducting ME/CFS research. But NIH responds: No, because there aren’t enough researchers and we won’t increase our ME/CFS spending.

Put another way, ME/CFS has a problem because there are not enough researchers. CFSAC proposes a solution of a data platform that could attract the interest of new researchers. NIH says no, because you don’t have enough researchers.

Wait, what?

There Will Be No RFA

The second recommendation was that NIH fund an RFA to address the gaps in ME/CFS research. NIH’s response? No. And the reasoning on this one will make your head hurt, it is so circuitous.

Unfortunately there remains a lack of definitive evidence regarding the etiology, diagnosis, and treatment for ME/CFS. As such, issuing a Request for Applications (RFA) would not be an effective strategy as RFAs generally encourage a narrowly defined research area that addresses more specific gaps in scientific knowledge.

First of all, NIH issued an RFA for ME/CFS in 2006 and it was targeted at Neuroimmune Mechanisms and Chronic Fatigue Syndrome. So the gaps were obvious enough to issue an RFA eight years ago, and more gaps were identified at the 2011 State of the Knowledge meeting, but now we don’t know enough to target those gaps????

Second of all, why is there a “lack of definitive evidence”? Obviously, because NIH funding at $5 million a year is not likely to produce much in the way of definitive evidence on etiology, diagnosis and treatment.

It seems to me that what NIH is actually saying is: we haven’t provided enough funding to identify definitive evidence, and because you haven’t identified definitive evidence we can’t provide you with more funding. If that doesn’t qualify as circular reasoning, I don’t know what does.

What this response tells us is that if NIH persists in this approach, we will be waiting a long time for an RFA or increase in funding. We will have to wait until a) there is a miracle discovery on etiology, diagnosis and treatment or b) 10 to 15 years for the career development idea to produce more researchers who are doing ME/CFS research.

Despite the thorough background and support for the recommendation provided by CFSAC, despite letters from members of Congress in support of an RFA, despite the pleas of advocates and organizations like IACFS/ME, NIH is steadfastly refusing to provide the one thing that we know would accelerate research progress: the money. UNACCEPTABLE.

What You Can Do

The NIH response leaves the door open just a crack – and that crack could make all the difference. The response says that RFAs are “designed to build upon recommendations . . . that incorporate findings from workshops and conferences.” Remind you of anything? Think P2P.

This makes the P2P Workshop more mission critical than ever, especially now that the draft systematic review has been published. The P2P report is supposed to identify gaps in ME/CFS research. NIH has left the door open to an RFA that incorporates findings from workshops. So we need to do everything possible to make sure the P2P report identifies accurate and appropriate gaps.

The systematic review says that CBT is moderately effective. It treats all the case definitions as equivalent. Remember that this review is the single piece of evidence given to the P2P Panel in advance of the Workshop. Do you want the P2P Panel report to incorporate those findings? Do you want an RFA based on findings like that?

I don’t. So here is what you can do:

Now is not the time to lie down. NIH says No? I say push back. This is a critical moment. If we slip and fall now, the consequences will affect us for many years to come.


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19 Responses to NIH Says No, and Also No

  1. Ruthann says:

    I tried to read some of the systematic review last night and I got so bummed I had to stop. I was bummed for two reasons: 1. I used to be able to read and understand this type of info so easily because I was a researcher and did it everyday. Now just reading 5 pages had me exhausted and confused. 2. I wasn’t so confused that i missed how detrimental this review may be for people with CFS. Now I read about what the nih has done and I am even more bummed. Hope to get over the bummed part soon and try to follow the links you left to make it easy for us to act. It seems daunting at the moment, but maybe I will find more energy later. Thank you for all you do. You are an amazing advocate for us all and I wish I had more to contribute.

    • Jennie Spotila says:

      We are working really hard to digest the report and formulate a response. I will definitely have more information to share so that we can make it easier for people to comment if they wish. This is a really hard report to read, especially for patients. Hang in there!

  2. NK17 says:

    “It treats all case definitions as equivalent”!!!!!!!! They will never learn, they don’t want to learn, they are obviously blind and biased. I wonder what is Lenny Jason take on this?!
    It’s evident to me that the obstinate refusal to develop and maintain a database is just another way to control true information and solid ME research data to come to the surface and keep on muddling waters and spin a web of lies, or shall I call it propaganda?

  3. Ess says:

    Yes–LIES–muddying/’muddling’ the waters–clear intent to DO HARM!! That ‘little window to speak’ = leading the lambs to the slaughter. There are EVIL SINISTER forces at work here, folks; it should be all too clear by now!

  4. Michelle says:

    While I’m working on a longer comment (er…essay?lol) to the Draft (I’ve only made it through the Exec Summary), I do think it is important to add one caveat to the comment that it treats all definitions as equal. While they fail to specify (at least in the ES) which studies used which definitions, they do single out the Oxford Criteria as the worst of the lot and especially unhelpful for getting anywhere research-wise. While there is plenty in the study that is unfortunate (and expected), there is also plenty that is helpful. I found myself cringing at parts, true, but also found myself at least as many times (if not more) saying yes! exactly!. I really really really think it’s important that we not write this thing off just because of its faults but focus on its entirety. As hard as it is given just how badly we are suffering, we must channel our anger into what is constructive rather than destructive.

    Regarding this NIH response, I have one word: Congress. It’s the only thing NIH listens to. Yes, we absolutely must attend and comment on P2P. But we also must absolute get Congress involved. Easier said than done, I appreciate.

    • Jennie Spotila says:

      I agree that we should point out what they did correctly in the report, as well as what they did not. I have to dig into the evidence tables, but if they believe Oxford to be the worst of the lot then I hope they graded all studies using that criteria as fair or poor in quality.

  5. Ecoclimber says:

    Should this come as any surprise to anyone? Hello!

    Given the historical track record by the IOM concerning the Gulf War Veterans with Gulf War Illness ( GWI ) and the horrific and tragic treatments options recomended by the Institute of Medicine ( IOM ) of talk therapy, meditation, acupuncture, CBT, biofeedback, aerobic exercise, Yoga!!
    ( ), what do you Expect?

    This is nothing more then a dog and pony show, a ploy if you will, by DHHS, to appear as though they are addressing the needs of the ME/CFS patient community when the ‘real agenda and policy’ is being implemented behind our backs to merge ME/CFS with CMI. We can just observe the disasterous results of the treatment modalities promulaged by the IOM which resulted in twenty-two of our brave Gulf War Veterans committing 22 suicides per day (CNN) for lack of proper and effective treatment and care, to know the fate for the ME/CFS patient community.

    This policy is driven not by DHHS but by the Executive Branch. This is an executive policy decision which I stated from the very beginning. The executive policy of the U.S. is to align this country with the medical policies of the UK, NZ, Canada and Australia. Otherwise, a US policy that countermands Wessely and his ilk concerning ME/CFS, Fibromyalgia, GWI with proof of an ogranic vs. psychological cause, would undermine the policies of those countries. Strategically, the U.S. needs to hold the ‘five eyes alliance’ together. It would also overturn the historical ten year record and nine reports of the IOM concerning the cause of GWI, Fibromyalgia, Chronic Fatigue Syndrome and would require the VA to drastically adjust treatment options that will be expensive.

    The powerful Medical and Disability Insurance industry along with the APA and their special interests groups (PAC) are spending hundreds of millions of dollars per annum for lobbying and targeting members of Congress and funding Congressional and Presidential election campaigns to influence legislation that is most favorable to their respective positions…think NRA.

    The only way to challenge these decisions is through the utiltization of the judicial branch of government to protect our rights. By inaugurating judicial action through the filing of a civil lawsuit for Injunctive Relief against the IOM and HSS or by filing under RICO, a civil class action lawsuit against certain individuals within HHS, is in my opinion the only way to prevent the inevitable.

    This could not be made any clearer than the the case that was brought before the United States District Court for the Northern District of California against DHHS for violating Federal law under the FOIA. The U.S. District Court ruled in favor of the petitioner. ( )
    which clearly demonstrates that certain individuals within our Federal government have no qualms in violating Federal Rules of Procedure and Law. How many instances has this occur concerning the circumstances surrounding the IOM contract, CFSAC rules and the P2P. For many, the P2P is a ruse set up by certain members within HHS as a safety net just in case the IOM decision is unfavorable to the government’s position on ME/CFS. The Judicial branch of government can be our friend. 🙂

    The other alternative is to skirt the NIH altogther and concentrate on raising funds for research by soliciting private donations through social media, corporations and foundations. It can be accomplished. The ‘Chronic Fatigue Initiative’ funded by the Hutchins Family Foundation is just one prime example.

    Thanks Jennifer on your tireless efforts on behalf of the ME/CFS patient community!

  6. Ecoclimber says:

    Messed up on moving this sentence around. “IOM which resulted in twenty-two of our brave Gulf War Veterans committing 22 suicides per day (CNN)”

    Should read: “IOM which resulted in our Gulf War Veterans committing 22 suicides per day (CNN)”

  7. kathy d. says:

    Thank you for figuring this out and explaining it. I must say I’m shocked, but not surprised. NIH is continuing its obstructionism on ME/CFS, and instead of helping to understand this disease and promote research, it’s putting a block on it.

    NIH simply doesn’t want to spend money on this disease nor help to advance the understanding or scientific research about it.

    So, Jennie is right.We all have to push back. How I wish we could “storm the Bastille,” or sit-in outsdie or inside the NIH buildings, but since we can’t, we have to put pressure on through social media, phone calls, etc., and whomever can go should go.

    Is there a way those of us who can’t go could contribute towards others going?

    • Jennie Spotila says:

      Yes! Sign up for the videocast and encourage others to do so. Submit a written comment on the AHRQ report (help coming soon). Watch the meeting and submit questions/comments via the webcast tool. Plan to submit a comment on the P2P report in December. There is A LOT that people can do, even if they can’t attend the meeting.

  8. Valerie says:

    Jennie, can people from other countries comment on any of these issues such as the P2P report….ie Canada?

  9. Spot on Ecoclimber! As I was catching up on Jennie’s blogs (been in a flare and my brain simply won’t work) my initial thought was…”Here we go again! Think of the bureaucratic nightmare regarding GWS.” Not enough data? Give me a break. Check with Simmaron or the CFIDS Association. They don’t need to reinvent the wheel. I have been in the Harvard Nurses Health Study on Women’s Health since 1983 and was instrumental in getting them to include a question for CFS (Albeit, it is a very small piece) and they haven’t lost my data or my blood and urine yet and are asking to reuse it. (Guess they want VERY long term data regarding us 60-70 yr olds.) This is ludicrous. I will share Jennie in hopes we can get folks to write in. @Ecoclimber

  10. Jennie, contact information for congressmen and congresswomen can be found on my website here.

  11. dave says:

    Unless and until, people in pain are adequately represented at NIH, CDC, VA, HHS-then the debate will continue to be dominated by professionals who have institutionalized their interests and occupational strategies in the aforementioned agencies. Is it no wonder why the IPRCC consists of members of organizations who were under investigation for opioids? We have a capitalistic health care system focused on the profits of the health care industry and not the good of people in pain. That is why my petition- the American Pain Rights Act calls for people in pain to have adequate representation in governemtn agencies. But so called professional experts- leave much to be desired in terms of what they know- but more importantly they are extremely undemocratic and self centered.

  12. dave says:

    DHHS has representatives from the health care industry that call the shots to the executive branch and Congress- In the HELP legsilation they failed to ensure adequate representation of people in pain. They could have enacted Recommendation 86-6 of the ACUS- which would have ensured all Americans having a voice in the agenda at HHS and the VA. But now, just as before professionals have institutionalized their occupational strategies and regard the views of people in pain as inferior vernacular performances- to be ignored. The remarkable thing to me is how ignorant professionals at HHS are with regard to even their own biomedical view of illnesses-and also the “biopsychosocial model” some of them claim to beleive in. The simple truth is Congress is too lazy to be bothered hearing and considering from those outside of the health care industry-and so they justify their decisions as being based on what the expertstestified to-and so unless there are structural changes in institutions- we will have a long march through them.

  13. Billie Moore says:

    Ken Friedman has given me permission to print the followings here.

    While it is always of some benefit to be civil and maintain a dialogue, the NIH in the area of Chronic Fatigue Syndrome has always been dishonest and corrupt. Without some external force compelling reform, there is little expectation (at least in this quarter) that business will not continue as usual.

    When I [Ken] submitted my last grant application to the NIH to study an aspect of Chronic Fatigue Syndrome and the grant was rejected for reasons (written in print) that were specious, I complained to the Study Section Secretary. The Study Section Secretary admitted that the grant was scored low and rejected for reasons that did not exist but refused to honor my request that the grant application be reconsidered. The fate of Ian Lipkin’s gut microbiome grant suggests that there has not been improvement in the fairing of novel, ME/CFS grant applications at NIH: NIH funds what it likes; funds what it wants.

    Each and every activity that the NIH performs allegedly on behalf of ME/CFS research, education, and patient care is done under false pretenses. All of it comes from the Office of Research on Womens’ Health when the illness is not a women’s illness. They perpetuate a lie, we sit there and take it. There will be no honesty until ME/CFS is given a legitimate home at the NIH based upon the kind of illness that it is.

    Ken Friedman

  14. Ess says:

    @Billie Moore
    There you go, telling it like it is @ HHS–NIH. We certainly have more than enough experience with HHS–NIH, et al regarding Chronic Fatigue Syndrome to know of the dishonesty and corruption that abounds! AND, worse–it is allowed to happen–three decades’ worth!! CORRUPTION — NO accountability. Lives LOST; lives DEStroyed.

    Thank you very much to Ken Friedman and Billie Moore for sharing and exposing more of the DECEIT, LIES and actions AGAINST ME/CFS patients.

  15. Sue Jackson says:

    After a month of crashes, infections, and a couple of milestone events in my life, I am soooo far behind in what’s going on in the ME/CFS world. As always, I turned to you, Jennie, to catch up and feel bad that I haven’t stayed up-to-date.

    Wow, these statements from NIH are really disheartening and frustrating. I find it odd that they committed to ME/CFS enough to start a P2P process but then turn around and show this considerable lack of commitment in other ways. Troubling, for sure.

    Thanks for the update – I need to read some more of your recent posts!

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