Occupy M.E.

Among the $53 million in RFAs issued by NIH last week were two RFAs for pilot clinical trials in pediatric chronic kidney disease. These are significant for us because the RFAs establish a network of three participating clinical centers and a coordinating center. Total being committed to the project? $1.5 million. That includes the money for the pilot clinical trials themselves, as well as all the infrastructure aspects of the arrangement.

Obviously, we don’t know whether this is predictive of the money that will be offered in the ME/CFS RFAs in December. But it is important to realize that RFAs don’t have to be huge, even when they support multiple centers and data coordination. We won’t know how much NIH is committing to ME/CFS until the RFAs are actually published.

Here are the current cumulative numbers:

And here is the table for FY 2017 alone.

If you want more background on the RFA Ticker, read the inaugural post.

Another huge week for RFAs at NIH! Last week alone, NIH issued 17 RFAs for a total of more than $94 million.

ME/CFS research did not get an RFA, but we did get official news about the RFAs promised us last year. NIH published notice of intent to issue funding for ME/CFS Collaborative Research Centers and a Data Management and Coordinating Center. Here is what we learned in the Notices:

• The National Institute of Neurological Diseases and Stroke is the only named participating Institute. This fits with the rumors that other Institutes have not been eager to pony up the money for RFAs.
• “The overarching goal of this initiative will be to establish a network of Centers that will work independently and collaboratively to define the causes of and discover improved treatments for ME/CFS.”
• “The intended FOA [Funding Opportunity Announcement] will solicit applications that propose research on ME/CFS.” Emphasis is placed on longitudinal studies, early stage basic and clinical investigators, and an educational component.
• The Data Management Center will manage and coordinate the data collection at the Collaborative Research Centers, as well as data mining and data sharing. Each Collaborative Research Center will be expected to collaborate with the others and use the Data Management Center.
• The RFAs will not be issued until December 2016, and funding will begin in September 2017 at the earliest.
• No dollar amount was specified. The number of separate Research Centers was also not specified.

A key point is that NIH will be using the U54 mechanism for funding the Research Centers. This is a cooperative agreement mechanism, which will give the funding Institute(s) substantial staff involvement. In a regular research grant, NIH gives the investigator money to do the project and is hands off until results. But in cooperative agreements, NIH remains substantially involved in carrying out the activities. This seems like a good thing, although we’ll have to see how it plays out.

Collaborative Research Center awards can be quite large or quite small, depending on the context. For example, NIH awarded $35 million to three centers for five years of research into Fragile X syndrome, a genetic disorder. But in another case, awards to support collaboration with the Clinical Care Center were limited to $500,000 (ME/CFS was listed as one of the areas of interest for that program).

At this point, we can only speculate on the number and size of awards that we will see for ME/CFS research centers. I know that bureaucracy moves slowly, but the earliest funding under these RFAs will be September 2017 – almost two years after Dr. Collins announced his “big” initiative on ME/CFS.

Regardless of how the details play out, I hope that many institutions will apply for funding under these RFAs when they are finally issued. One of the worst possible outcomes would be a very low number of applications, because this would confirm the NIH world view that there just aren’t that many researchers interested in ME/CFS.

Until we know more, we have to stick to the data available. Here are the cumulative numbers:

And here is the table for FY 2017 alone.

If you want more background on the RFA Ticker, read the inaugural post.

Have you heard the expression “Go big or go home?” That is the perfect description of last week’s RFA totals. NIH only issued one RFA last week, but it was a big one. The set aside funding of $28,750,000 more than doubled the funding NIH has dedicated in FY2017 so far.

I am very confident that you will not be surprised when I tell you this single RFA was not related to ME/CFS. We’re still waiting on that. And that single RFA of $28 million was about four times more than all of the money spent by NIH on ME/CFS last year.

Here are the cumulative numbers:

And here is the table for FY 2017 alone.

If you want more background on the RFA Ticker, read the inaugural post.

Fiscal Year 2016 ended on Friday, September 30th. Were you holding your breath for that ME research RFA? I hope not.

NIH did not issue an RFA for ME research in FY2016. However, NIH did issue 352 RFAs in that time period, for a total of more than $2.8 BILLION. Last week alone, with the fiscal year coming to a close, NIH issued more than $60 million in RFAs.

I started this RFA Ticker with the goal of giving advocates data to help them assess if NIH was doing everything it could to promote and fund ME research. Seeing how much NIH is doing in other areas helps shine a bright light on what it is not doing in ME.

After Dr. Collins’s comments at the March 8, 2016 telebriefing, I received a suggestion that I stop the weekly Ticker because surely new funding was just around the corner. A similar suggestion was made after the concept clearance for research network funding. I’m paraphrasing here, but the general sentiment was Lighten up, NIH funding is on the way.

I said then and I say again now: show me the money. Until there is money on the table, there is no money on the table. Telebriefings and promises and status reports are just words. People with the best of intentions can talk until they are blue in the face. The metric that matters is funding. Promises don’t find cures.

And so next week, I will begin the tally for Fiscal Year 2017.

• Total RFAs Issued by NIH: 352 (Fiscal Year 2016)
• Total Dollars Committed to RFAs: $2,840,680,617 (Fiscal Year 2016)
• Total RFAs for ME/CFS: ZERO (Fiscal Year 2016)

If you want more background on the RFA Ticker, read the inaugural post.

We are down to the wire, friends. The #MillionsMissing protest is on the 27th, and we have millions upon millions missing from ME research at NIH. Specifically, NIH issued 15 RFAs last week for $62 million, but ME did not get a damn thing. 

The end of the fiscal year is this Friday. Do not hold your breath. 

• Total RFAs Issued by NIH: 343 (October 2015 to date)
• Total Dollars Committed to RFAs: $2,776,271,617 (October 2015 to date)
• Total RFAs for ME/CFS: ZERO (October 2015 to date)

If you want more background on the RFA Ticker, read the inaugural post.