“Our intention is to evolve the SolveME/CFS BioBank™ into the most sought after resource for ME/CFS research in existence”
About five years ago Suzanne Vernon completely revamped the CFIDS Associations approach to research
In 2008, seeking to shift their focus to research, the then CFIDS Association of America (CAA) (now The SolveME/CFS Initiative) hired their first Research Director, Suzanne Vernon. Vernon completely revamped the organization’s approach to research. Research grants would now go through a peer-reviewed, multi-level analysis before approval. Instead of working alone, researchers were required to regularly communicate and collaborate with each other. In the keeping with the CAA’s new open source policy, they were required to provide their data to an open data source platform so that it would be available to all.
Two years later Vernon created the crown jewel of the Association research program, the SolveCFS BioBank and Patient Registry. One of the first ME/CFS Biobanks created, it was designed to maximize study efficiency, support collaboration, and, most importantly, attract new investigators to the field.
Vernon’s new more rigorous approach paid off as approximately $1 million in SolveCFS grants turned into $8 million in usually elusive NIH grants, with promise of more to come as recent applications make their way through the NIH granting process.
The BioBank was another entity entirely, though. A major goal of the Biobank was to entice new researchers to the field – a critical need. Unless the future is going to look like the past – something no one wants – new researchers with new ideas, new tools, and new funding must be engaged in ME/CFS research. But how to do it in this oh-so-maligned field?
The SolveCFS Initiative built the biobank — hoping they would come
Dr. Bateman has noted that every professional that’s entered this field has paid a price. Dr. Montoya’s mentor warned him that focusing on chronic fatigue syndrome would ruin him, leaving him like a drunk lying in the gutter. Well-established researchers in other fields such as Ron Glazer have left the ME/CFS field in disgust over their inability to get funded. Researchers dependent on NIH grants couldn’t be blamed for thinking twice about entering a field perennially ranked in the bottom five percent in NIH funding.
The SolveCFS BioBank had a lot going for it, though. It’s rigorously-characterized samples meant the time and costs of studies could be cut, and the ability to access multiple data points from each sample could conceivably increase the explanatory power of their studies exponentially. “Big data” is in, and the BioBank with its REDCAP data retrieval component is also essentially a big data repository.
So they built it – hoping they would come.
Are They Coming?
“We built this [biobank] to be shared as widely as possible in order to increase the interest in ME/CFS research, increase the numbers of minds tackling ME/CFS, and accelerate the rate we get to objective diagnosis and treatment.” – Suzanne Vernon
The answer is an unqualified “yes”. The SolveME/CFS Initiative and its SolveCFS BioBank has rather quietly accomplished something very special. They’ve enticed a bevy of new researchers to enter this field without paying them any more than the cost of shipping samples.
Lasker Award winner Micheal leads a list of top researchers using SolveCFS Biobanks
They’re not just any researchers, either, and they’re not using yesterday’s technology. Some legitimate stars are using biobank samples and many are using some of the best technology in the world. Houghton’s Lasker Award puts him in a very select group of researchers. Unutmaz is a part of 300 million dollar Jackson Genomic Laboratory effort that’s attracting the best and the brightest in genomic research. Dr. Steven Elledge runs the fifty person plus Elledge Lab at none other than Harvard. He’s using new technology to assess all the viruses a person has ever been exposed to. Eric Delwart is a senior investigator works at the Blood Systems Research Institute – the place the Feds often go when a problem with the blood supply occurs.
In about three years, the Biobank and Suzanne Vernon have enticed eight new researchers to enter the seemingly treacherous field of ME/CFS.
Autoantibody Search
A serendipitous finding has lead to a paper on ME/CFS and perhaps a study
The NIH failure to approve a SolveME/CFS grant proposal (they reportedly trashed it) to explore autoantibodies a couple of years ago was particularly disappointing given the Rituximab results, but hardly surprising. Suzanne Vernon simply turned around and found an investigator willing to do the job.
Her invitation to Michael Cooperstock to attend a Banbury meeting at which Fluge (of the Rituximab studies) was speaking piqued his interest. He then interested three more, with Madeliene Cunningham , David Kem and Armin Alaedini. The results of their antibody tests were negative, but as often happens, a serendipitous finding by Alaedini, involving a different set of antigens, is going to show up in a paper. An NIH-sponsored study may follow.
- Cost to the SolveME/CFS Initiative and the ME/CFS community – the price of shipping.
Digging Deep Into Your Viral Past
At Harvard Elledge is looking deeper for traces of viruses than anyone has looked before
Steve Elledge at the Harvard Medical School got wind of the SolveCFS BioBank and contacted Suzanne Vernon. His project ended up taking a deep dive into ME/CFS patients viral past in an attempt to discover what went wrong way back when. His cutting-edge antibody technology that will examine millions of antigens from hundreds of viruses will reveal all the viruses a person has been exposed to in the past. A positive result showing people with ME/CFS are more likely to have been exposed to some viruses than have healthy controls would reinvigorate pathogen research. The fact that the results from this study have been submitted and further research is underway suggests he’s found something.
- Cost to the SolveME/CFS Initiative and the ME/CFS community – the price of shipping.
The Big, Big Data Man
The Jackson Genomics Lab – a $300 million dollar bet – is attracting top researchers v- and doing ME/CFS research
Suzanne Vernon’s pursuit and eventual “capture” of Derya Unutmaz was particularly gratifying. Working at brand spanking new Jackson Genomic Lab Unutmaz first conducted a small but intense immune profiling study using the SolveCFS BioBank samples. Immune data on this scale has never been captured in ME/CFS before. As he did that, he incorporated the results from the ME/CFS group into a database containing many other disorders. A unique immune profile that showed up would be big news.
- Cost to the SolveME/CFS Initiative and the ME/CFS Community – the price of shipping.
Unutmaz’s study reveals a key asset the SolveCFS BioBank brings – the ability to use easy-to-access samples to do relatively inexpensive pilot studies. If something pops out, as it did with Allaedini, or as it appears to have happened with Unutmaz (he has since expanded his study and is looking at more samples), they can then pursue their findings further.
The Biomarker Study
Will Houghton finally find a biomarker in ME/CFS? Look for a paper in 2015
Michael Houghton’s University of Alberta may be the most intriguing and mysterious SolveCFS BioBank under way. The discoverer of the hepatitis C virus and a Lasker Award winner, Houghton brings some heavy credentials to the ME/CFS field. Houghton first got engaged in chronic fatigue syndrome research during the short but intense XMRV era. He’s now working with Amir Landi to validate a potential diagnostic biomarker they’ve identified. Judging from his hope to have his results ready for prime time and publication in 2015, the search, which has been underway for some time, appears to have gone well.
- Cost to the SolveME/CFS Initiative and the ME/CFS Community – nothing! (A possible biomarker for free – how cool that would be :))
Eric Delwart – Deep Sequencing to Uncover Viruses
Suzanne Vernon contacted Eric Delwart of the renowned Blood Safety Research Institute to see if he was interested in bringing his big guns to bear on viruses, and he was. His study results proved to be similar to Ian Lipkin’s – he found nothing, which is disappointing, but we now know that his protocols are not going to show viruses. That’s one question answered and one more study that does not need to be done. (Lipkin has changed his testing protocols, by the way. He’s now looking for herpes and other viruses in white blood cells.)
*Pursuit of Viruses Continues – Vernon is currently discussing further exploration of these viral sequences by a virologist specializing viral metagenomics. She reports the investigator is intrigued and she’s hopeful a study will commence in the spring.
- Cost to the SolveME/CFS Initiative and the ME/CFS community – the price of shipping.
Breaking the ME/CFS Ceiling
Shelley Wang is producing outcome measures for ME/CFS – for free
Shelley Wang MD and two other investigators are using the questionnaire data (some from Lenny Jason’s DePaul Symptom Questionnaire) to evaluate the importance the “ceiling effect” plays in clinical trials. The ceiling effect occurs when ME/CFS patients score so high on symptom scales that even if they get worse during, say, a graded exercise trial, it won’t show up in the results. The ceiling effect could lead to significant under-reporting of harms.
Wang and her colleagues are also working on producing outcome measures that drug companies can count on to accurately reflect the results of clinical trials. Both the AHRQ and P2P draft reports emphasize how important to the field as a whole it is to develop these. Drug companies, in particular, need to have outcome measures they have confidence before they’ll spend money on ME/CFS.
- Cost to the SolveME/CFS Initiative and the ME/CFS community – nothing.
More to Come
Besides the one stated above, Suzanne Vernon stated she’s in discussions with four more investigative teams. How does a researcher get access to SolveME/CFS BioBank samples? They submit an application/proposal and provide other required documents including their Institutional Review Board (IRB) approval. Their application is peer-reviewed, and if it passes scientific muster, the samples/data are released.
Nice Return on Investment (ROI)!
Suzanne Vernon has produced a nice return on investment for the SolveCFS Initiative
Adding in the outside projects the SolveCFS BioBank has brought in to the $8 million dollars in NIH grants pulled in by Solve ME/CFS Initiative investigators thus gives the Solve ME/CFS Initiative’s research program under Suzanne Vernon a very nice return on investment (ROI).
There are other Biobanks out there, but it’s not clear how much they’re being used. When last heard the NIH Biobank had given one group – the Simmaron Research Foundation – access to its samples.
As its data base grows, filling with data that describes ME/CFS in ever more varied ways, the SolveCFS BioBank should only become more attractive to researchers, which brings us to the possibility of the “mega studies”.
The Mega Studies
Consider the case of someone with severe ME/CFS – Bob Miller. Bob’s natural killer cells simply aren’t functioning – they’re at 60% of normal. Some of his cytokine levels (Il-6- 6,000; IL-8 – 26,000) are almost off the charts, his CD4 T-cells are a third of what they should be, he scores 27% of average on a treadmill tests, his frontal lobe aren’t working well, he’s not getting REM sleep, and his herpesvirus antibodies are elevated.
Bob’s blood samples are in SolveCFS BioBank. Who knows what studies they’ve been used in, but consider that the BioBank may now have epigenetic, immune, biomarker, and autoantibody data on Bob.
With the easily-scannable REDCAP system, researchers could conceivably pluck out the Bobs in the database – people with major immune dysfunction – and put all the pieces together. As the Biobank contains more and more data, this type of mega study becomes more and more possible and more and more enticing. When I asked Dr. Vernon about whether anyone was yet doing this type of study she said “stay tuned”.
Sample “Fatigue”
The original samples from the GlaxoSmithKline XMRV study appear to have been used quite a bit. When I asked Suzanne Vernon how they’re holding up she said,
“What a heaven-sent windfall the study with GlaxoSmithKline was! Most of the peripheral blood mononuclear cells (PBMCs) have been depleted. There are still many plasma aliquots. Remember, it is VERY important to understand what these samples can and cannot be used for because of the tubes used to collect the sample and how these were processed.”
What’s next for the SolveCFS BioBank?
Suzanne Vernon said the next goal for the biobank is to:
“Grow! The award from the Falk Medical Research Trust gives us the opportunity to work with Dr. Cindy Bateman and “restock” our inventory for studies that require clinically diagnosed and characterized patients. For the other 1,000 plus that have signed up as “Research Ready”, we are embarking on an exciting project that I hope to be able to describe further early in 2015.”
______________________________
Donation Drive – the SolveCFS Initiative is currently in the middle of a donation drive. A $50,000 matching grant means your donation before Dec 31st will be doubled. Find out more about donating here.
Signing Up for the SolveCFS BioBank – If you haven’t yet signed up and want to, contact Gloria Smith at BioBank@SolveCFS.org or by phone at 704-362-2343 to learn more. The biobank needs both ME/CFS patients and family and friends who can serve as healthy controls.
This is great news. I would like to know though, what are the components of a ‘rigorously-characterized sample’ . Can someone tell us the exact characteristics some time? What is their symptom list and other characteristics?
If they are like Bob Miller’s, it’s reassuring that they’re on the right track.
The samples were all from patients that came from ME/CFS experts like Dr. Peterson, Dr. Klimas, Dr. Bateman, etc. for the big XMRV study. I imagine that they mostly came from patients who were quite ill. I know Corinne Blandino’s samples from Dr. Peterson, for instance, are in there.
Hi Cort,
Thanks for the encouraging info on these studies! Do you have any idea on the timing of when will hear some of the results? It would be nice if we hear something in the 1st half of 2015!
I’m also curious if you’ve heard anything about Dr. Montoya’s work we thought we’d hear about last year? Maybe you can do an interview with him to get an update!
Scott
Would love to do an interview with Montoya – he’s tough to get a hold of, though :).
The Alladeini and Houghton study results sound like they’re going to be published this year. I’m really excited about the Houghton study. He’s a very careful researcher – if he publishes something that means he’s really found something…
🙂
I had the pleasure of meeting Suzanne Vernon, Ph.D. in Santa Barbara 8-10 years ago. She was so encouraged about the future!!! Never thought I’d still be ill, but now my brilliant daughter who is in physiology and epidemiology just wrote her first paper on ME/CFS. Here’s a great reason for us to support our family and friends in their scientific research careers—they understand our lives—it may be one of them who figures out how to help us!! GO SCIENCE!!!!
Yes, indeed! That’s great to hear about your daughter 🙂 I imagine some sons and daughters will go into medicine because of this.
Is there an actual physical location of this biobank? Seems it would be very
expensive to maintain.
The SolveCFS BioBank information I received since signing up in August of this year states it is “an ‘on-demand’ sample collection approach”. That is, they will contact me for a sample when I’m selected for a study.
From other replies it does sound like there may have been some samples collected and banked before now though.
The samples are banked somewhere – I don’t know where. Actually there are quite a few ME/CFS biobanks now but none that I can tell that are attracting new researchers like the SolveME/CFS Initiatives BioBank is.
In late August as the Ice Bucket Challenge was winding down, I was feeling envious, jealous, and frustrated by their success and sulky and resentful that we ME/CFS folks hadn’t stumbled on something like that! …I’m hoping that owning up to such obnoxious and negative feelings might lessen in some way the karmic burden, and the embarrassment of having just admitted them “out loud”! Sigh… 😀
The positive that came from that wallowing about was that I finally acted on my desire to sign up for the SolveCFS BioBank. I requested and returned the paper consent form which has to be done by snail-mail, been assigned an ID number, and completed a SolveCFS BioBank Questionnaire (can be done on-line or on a paper form via Postal Service).
The information I’ve received states that the BioBank uses an “on-demand sample collection approach” and I will be contacted to provide a blood or saliva sample if/when I’m selected for a study. I may also be asked to provide additional information for the study. I can choose to participate or not when contacted. I may be charged by the lab or clinic I go to for a blood draw; I would use my provider’s clinic and intend to ask if they might waive charges given it’s for research – worth a shot or worth the cost either way.
I did receive one donation solicitation from SolveCFS in November so signing up appears to place one’s contact information on the SolveCFS mailing list.
From the SolveCFS BioBank information sheet: “anyone age 10 years and older can participate” and they “invite the family and friends of ME/CFS patients to participate…because it helps us understand what is different and possibly causing Me/CFS.”
Now that I have a feel for what’s involved, and given the possible increased awareness of ME/CFS via “Unbroken”, I’m considering putting out an invitation to sign up for the BioBank to friends and family via FaceBook. …And now that I’ve said that out loud too, I’d better get to it!
Perhaps this is a way we can ride the awareness wave at this time. No bucket of ice water or polar plunging involved – just request the Informed Consent and, when it arrives, cozy up with some warm tea or hot chocolate, fill it out, and send it back!
To Cort Johnson,
Did you ever live in Lewes DE? I used to know someone with that name who worked in real estate. Kath Johnson
🙂 Afraid not – never been to Delaware or worked in real estate. I’ve bumped into one other Cort Johnson in my life…:)