The NIH on ME/CFS in 2012 Pt III: Neglect Imperils ME/CFS Research

February 6, 2012

Posted by Cort Johnson

NIH neglect is on the verge of producing a downturn in ME/CFS research that may take years to recover from. Some background information is necessary.

The Effective Grant Program (and the Ineffective One)

The NIH produces two types of grants; Program Announcements (PA’s) and Requests for Applications (RFAs). Program Announcements ‘announce’ what kind of research the NIH is willing to fund; RFA’s announce what kinds of research the NIH is willing to fund and come with a guaranteed pool of money. (Guess which one gets better results?)

The funded grant proposals are important, even vital vehicles for drawing interest to controversial disorders like chronic fatigue syndrome which have trouble attracting researchers. One important facet of RFA’s are the increased grant acceptance rates that come with them.

Grant approval rates for first time ME/CFS grant proposals, for instance, were so low, running about 8%  in the mid to late 2000’s, that researchers quit the NIH in disgust.  High grant approval rates (@25%) for the 2006 Neuro-immune RFA for CFS indicated that RFA’s are the only vehicle that will reliably attract researchers to the field.

Unfortunately, RFAs have been few and far between with the last RFA for ME/CFS coming in 2006. A look at who’s getting what in the NIH CFS research program indicates these special funding opportunities are vital to the health of this field.

A Big Boost

The 2006 Neuro-immune grant package, as underfunded at it turned out to be, (only about half the funds were awarded), turned out to be a kind of seminal moment in the NIH CFS research program.  Discounting the XMRV studies, half the studies the NIH is currently funding originated in the 2006 grant package. The entire Light program of research, the Antoni studies, the Fletcher biomarker study, the Biaggioni study, the Theoharides study and the second Baraniuk study all grew out of the 2006 Neuro-immune grant package.

Running on Fumes

Since 2006 the NIH has relied solely on unfunded Program Announcements to spark interest for the ME/CFS field and the results have been predictable with few new investigators entering the field. Friedman’s Viagra study and Schuster’s viral study, both either finished or finishing up this year, are the only studies featuring an investigator new to the ME/CFS research field on the books. (The EBV Glazer proposal succeeded only when he stopped focusing on CFS and Stewart, Natelson and Freeman had already been funded for years by the NIH.)

In short, while the ongoing studies are valuable, the NIH is basically running on the fumes generated by its last grant effort 6 years ago and it’s ME/CFS program is long past due for an injection of new ideas and new blood into the field. Without another grant package to re-energize the field we can look forward to further diminishment in CFS research at the NIH.

Major Opportunity – Lost?

A major opportunity for an RFA arose with the Science Workshop in 2011, as workshops are usually done to prepare for an RFA.  We were told, however, that that decision regarding whether an RFA would occur would await until the outcome of the Lipkin study. That study should be done in a couple of months and we’ll see what the NIH says.

Their usual response is that there’s no money or it’s impossible  and the ME/CFS community has been heard this many times before.   As the NIH budget doubled in the early 2,000’s and agency figures spouted platitudes about how important ME/CFS was, funding for ME/CFS research declined dramatically.  Similarly former ME/CFS rep at the NIH, Eleanor Hanna, stated that funded grant opportunities (RFA’s) were in decline and there was no money for one for ME/CFS but 14 have been offered thus far this year for other disorders and over a hundred were published in 2011.

Even in these tight budget times the budgets for most disorders and conditions received increases in 2012. (CFS did not). Somehow there’s just never enough money in the NIH’s enormous budget for even a moderate increase in ME/CFS funding.

A Field Primed and Ready

No one can argue that the 2006 RFA was not a success; it opened several areas of research that continued to get funded long after the original grant ran out.  Given the progress that’s been made in ME/CFS over the past 6 years, the recent Rituximab finding, the strengthened research environment outside of the NIH (Research1st at the CAA, Chronic Fatigue Initiative, the Klimas Neuro-immune Institute at Nova Southeastern, Montoya’s effort at Stanford, PHANU, Mt. Sinai ME/CFS Research Center, Simmaron), it’s clear this field is primed to take advantage of a grant opportunity and a new RFA for ME/CFS would draw more interest and be more successful than the last one.

An RFA for ME/CFS in 2012 would undoubtedly open up new fields of research and producing an RFA should be the prime goal of ME/CFS advocates.

Foundation Laid

The NIH laid the foundation for a new RFA with the State of the Knowledge Workshop in 2011; all they need to do now is allocate funds for it. With no less than 30% of the NIH’s CFS studies ending this year, the NIH budget on CFS is about to tank without a new effort – a disturbing realization – but one which also means that a significant portion of the funds the NIH needs to fund the RFA should be available.

All the NIH, with its $32 billion dollar/year budget, needs to do is to flick its little finger at the the ‘$6 million’ CFS research program to provide it with the funding it needs to grow.

Will it continue on with its ‘business as usual’ approach – pitching pennies instead of dollars at ME/CFS – or will it begin to provide the money that the size  and scope of this disorder demands?

With XMRV and ME/CFS fading from the spotlight this may be a crucial year for the ME/CFS community and its most important funder – the NIH.

10 comments

{ 8 comments… read them below or add one }

MishMash February 7, 2012 at 12:59 am

It’s not just NIH that has it in for us. They are a govt institution; nobody expects them to do anything beneficial or clever. The puppet master pulling the strings in all this is Genentech, the creators of rituximab.

1) Original studies of Rituximab, a lymphoma drug, used on MS sufferers showed it to be strikingly effective in reducing lesions and symptoms. The original drug went off patent and generic copies will be produced.

2) So Genentech came up with a “me too” monoclonal antibody for lymphoma, on which they could make their billions and billions; and it would be “even better” than the original.

3) The newer version failed miserably in its trials because it resulted in too many complications and deaths. So no research is funded at all for MS sufferers. Because of money.

4) Upshot: MS sufferers get nothing. Like us, they get to rot in their homes and slide into oblivion. All because we have an obtuse and inwardly-collapsing NIH, unable to find any orifice with a flashlight, and Genentech, the fox in the hen house, leaving the sick out to rot and die in the streets. (This would not be happening in 1st world countries with “socialized medicine” by the way. Because America is the only place that allows drug companies to dictate the price of critical drugs unilaterally. Hence, who lives or dies, is crippled or well. Thank god for Norway or N. Zealand, where some semblance of the Hypocratic Oath still exists.)

If you think my opinions are off the chart, negative, uncalled for, then you should read this editorial in “Neuroimmunology” and my words will seem mild in comparison:

http://neuroimmunology.wordpress.com/2011/03/27/the-shameful-story-of-rituximab-in-multiple-sclerosis/

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Cort February 7, 2012 at 11:01 am

Actually I do expect the fed govt to do innovative studies and I think they are. We have a difference of opinion on that.

However I do agree with you on the Rituximab situation and the way our medical system operates. Genentech is looking after their own interest – that’s understandable – but there’s no one looking out for MS patients interest. The NIH should, in my opinion, fill the gap as drugs go generic – and do clinical trials for drugs that drug companies have no financial interest in funding.

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Ren April 3, 2014 at 8:18 am

In my experience, socialized healthcare is a Potemkin facade. Lives are continually rationed away and/or destroyed because those in power always have something “better” to spend money on than sick people.

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Bethe Burke February 7, 2012 at 1:08 am

ohh nooo

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Cort February 6, 2012 at 6:36 pm

Until Dennis Mangan came along,(and he is gone) the NIH had never done anything significant for ME/CFS without being forced into it. The hidden story about the 2006 Neuro-immune RFA is that it was actually based on the 2003 Neuroimmune Conference (workshop) but the NIH dallied so much that it took the CAA to get Harry Reid to go after the NIH to release the funds 3 years later. This was when the NIH was reaping the benefits of dramatically increased budgets….We’re up against a entrenched culture that simply negates the significance of ME/CFS…..and it does the same thing to its allied disorders – FM, IBS, Interstital cystitus, IBS – all mostly women’s disorders…Thank about that!

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Phoenix Rising February 7, 2012 at 2:33 am

Unit Dennis Mangan came along,(and he is gone) the NIH had never done anything significant for ME/CFS without being forced into it. The hidden story about the 2006 Neuro-immune RFA is that it was actually based on the 2003 Neuroimmune Conference (workshop) but the NIH dallied so much that it took the CAA to get Harry Reid to go after the NIH to release the funds 3 years later. This was when the NIH was reaping the benefits of dramatically increased budgets….

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Phoenix Rising February 7, 2012 at 2:35 am

We are up against a entrenched culture that simply negates the significance of ME/CFS…..and it does the same thing to its allied disorders – FM, IBS, Interstital cystitus, IBS – all mostly women’s disorders…Think about that! Women’s disorder getting short shrift – someone out to be able to build a campaign around that.

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Kathy D. February 10, 2012 at 10:01 pm

Wow, this is very sobering, although I knew the information from keeping up with this and other blogs.

What do we have to do here to get research and funding? We do need an ACT-UP FOR CFS! or OCCUPY CDC or OCCUPY NIH but we don’t have much energy to do this.

There is so much coming out with biomarker evidence from Dr. Komaroff, the Lights, others. And Dr. Lipkin is keeping the 11-researcher study going and then doing another study for viruses from the CFI grant.

The media coverage from the XMRV study and then retraction is fading, although David Tuller did have an article in the Feb. 7 New York Times Science section. It was a mixed bag, but probably raised an alert for more research to go on and the necessity of that.

Wish we could do a national e-mail blast, as a friend who is an Internet expert, always says, with letters automatically sent to Congresspeople (both Houses), our local state representatives, the White House, Kathleen Sibelius and the media. And a petition.

I don’t blame funding for other diseases. Sick people deserve studies and treatments for all serious diseases. I’m for cutting the military budget and funds for Wall Street, and using much for CFS and other diseases.

I wish we could all collectively do something and be heard.

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