SolveCFS Biobank Beginning

[jspotila]

I don't know how much this is costing the CAA. They were smart to find a way to get federal funding for the project. I imagine they are on the hook for test kits, etc.?

Cort, the Association does not have federal funding for the BioBank.

How much does the Biobank cost the CAA?

There is an annual membership cost paid to Genetic Alliance for the biobanking infrastructure and support. That is a fixed cost of $20,000 per year that does not change depending on the number of subjects enrolled and samples and stored. There are variable costs charged for the collection and storage of clinical information, blood samples, tissue samples and DNA samples. The Association will be charged for each subject enrolled, depending on the specific requirements for processing the samples that are obtained from that individual. Those requirements will change to reflect the nature of studies conducted. The present cost to the Association for each subject enrolled in the BioBank is approximately $450, based on the types of laboratory processing done on each sample. That cost is borne by the Association, not the BioBank subject. The only cost the subject is asked to bear is the cost (if any) for the phlebotomy, which ranges from $10-40. Collection tubes, shipping costs and materials are all provided. We will seek reimbursement of these costs with future studies and will try to make at-home phlebotomy services available, but at the present time our limited resources cannot support these additional expenses.

 

[Hope123]

I wanted to comment on the point about people participating in studies. In my prior life, I had some experience with research. People participate for a multitude of reasons, some of which could be judged as selfish and some of which could be judged as altruistic, but everyone has their own reasons for doing it. Few studies are ever totally benign and the Light study was potentially harmful in that exercise could cause a severe relapse for some of the participants. Perhaps some felt monetary or other compensation was appropriate for this or other risks (e.g. going to the clinic) they would be undertaking. Perhaps some were scared and did not want to find out whether they had a retrovirus or not. We don't know so let's not judge.

Re: funding the biobank. The biobank could start out as free for researchers to encourage interest but over time, depending on how things go, perhaps the CAA could charge a reasonable fee to institutions or researchers for access to defray costs. Also, I thought there was an ongoing intiaitive at NIH to fund registries, esp. for rare diseases? (CFS not rare but might as well be rare being an orphan disease.)

 

[starryeyes]

Teej (can I call you Teej?),

I'm sorry about any hurt feelings.

Thanks for your reply and right back at you! :Sign Peace:

Of course you can. :Retro smile:

 

[leelaplay]

I wanted to comment on the point about people participating in studies. In my prior life, I had some experience with research. People participate for a multitude of reasons, some of which could be judged as selfish and some of which could be judged as altruistic, but everyone has their own reasons for doing it. Few studies are ever totally benign and the Light study was potentially harmful in that exercise could cause a severe relapse for some of the participants. Perhaps some felt monetary or other compensation was appropriate for this or other risks (e.g. going to the clinic) they would be undertaking. Perhaps some were scared and did not want to find out whether they had a retrovirus or not. We don't know so let's not judge.

This is so true Hope. Thanks for the reminder.

 

[Kati]

I wanted to comment on the point about people participating in studies. In my prior life, I had some experience with research. People participate for a multitude of reasons, some of which could be judged as selfish and some of which could be judged as altruistic, but everyone has their own reasons for doing it. Few studies are ever totally benign and the Light study was potentially harmful in that exercise could cause a severe relapse for some of the participants. Perhaps some felt monetary or other compensation was appropriate for this or other risks (e.g. going to the clinic) they would be undertaking. Perhaps some were scared and did not want to find out whether they had a retrovirus or not. We don't know so let's not judge.

Re: funding the biobank. The biobank could start out as free for researchers to encourage interest but over time, depending on how things go, perhaps the CAA could charge a reasonable fee to institutions or researchers for access to defray costs. Also, I thought there was an ongoing intiaitive at NIH to fund registries, esp. for rare diseases? (CFS not rare but might as well be rare being an orphan disease.)

Very good points Hope.

 

[Stuart]

I had the same concerns as teejkay, I am concerned about the diagnostic criteria. It is common for doctors to have accepted idiopathic fatigue under CFS.

The CDC and CAA and many CFS doctors have participated in blurring the lines. Many past studies are tainted due to inclusion of idiopathic fatigue patients.

There are many who for self interests would like these patients to be continued to be included in patient and study cohorts. I hope this biobank helps get past that history.

Given the option I would donate to the group who tells me what the study is for; will give me the results; and wont charge me for donating my time and samples. This is a problem that I see, most PwME/CFIDS are in need of information on their health status.

Many patients cant get their doctors to do the tests, in the U.S. many have no health insurance and are years into the fight for disability benefits. In fact, these results may be what would help in that very battle.

Research is needed, so much time has been wasted as well as money on illegitimate studies, but a Patient Advocate is still needed! Not as an ambiguous amorphous group, but the patients themselves.

I dont see one.

 

[jspotila]

I had the same concerns as teejkay, I am concerned about the diagnostic criteria. It is common for doctors to have accepted idiopathic fatigue under “CFS.”

The BioBank study criteria clearly and specifically state that a subject MUST have a diagnosis under the Fukuda or Canadian case definitions by one of the four doctors listed (Bateman, Gluckman, Klimas or Lapp). Idiopathic fatigue, by definition, would not meet the stated BioBank study criteria.

 

[Hope123]

I don't have a problem with the CAA starting with these four doctors initially as long as there are plans to allow others to participate in it in the future. It's possible the CAA asked who was interested and these were the ones who responded. Also, for those concerned about whether the 'sickest' or whether the 'right' people will be included, with the exception of Dr. Gluckman, whom I am not familiar with, the other three docs have been involved in CFS care/ research for 15-20 years and are well known for being supportive of CFS sufferers. Dr. Klimas in fact is doing research on homebound/bedbound CFS sufferers. Can the CAA tell us more about Dr. Gluckman's background and work?

In terms of details about a study, this is usually given once you have expressed interest and the researchers decide you fit their selection criteria through usually painstakingly detailed subject consent forms.

 

[usedtobeperkytina]

well, I was feeling a little guilty because I was thinking I need to save my blood. Number one, less pricks means less likely veins will collapse. Secondly, as Klimas said, we have low blood volume. Not to mention traveling to the doctor and paying the fee.

But now I see you have to be a patient to one of these four doctors. Well, that leaves me out, here in Clay, Alabama. Not even one in Birmingham or any city in Alabama.

I will reconsider when you include doctors here. I understand choosing just a few, very knowledgeable doctors.

But I notice Peterson is left out.

Tina

 

[Hope123]

But I notice Peterson is left out.

Tina

Tina, this was my concern when I mentioned in other posts about why not merge the WPI and CAA biobanks together? Peterson is affiliated with the WPI bank.

Jspotila mentioned in another post that CAA assumed that WPI had their own rules and that the Genetic Alliance had their own rules about merging banks. Who knows how the CAA and WPI talk to each other? All I can hope for is that the CAA and WPI continue to work together for us. On the patient side, there's nothing to say you can't donate to both biobanks.

 

[jspotila]

I don't have a problem with the CAA starting with these four doctors initially as long as there are plans to allow others to participate in it in the future.

Yes, as the BioBank expands and resources permit then it is likely other clinicians will be able to participate.

Can the CAA tell us more about Dr. Gluckman's background and work?

Here is the information page on Dr. Gluckman at the University of Pennsylvania.

 

[Kati]

If I had the opportunity to give out 10 vials of blood for ME/CFS research, I would. Even if it meant that I'd crash-

I want out of this disease, and the only way I can get out is through research. And to facilitate research, already well defined cohort blood being available all at in the same place will be a great asset.

Thank you to CAA to put this bio-bank into place and I hope that it gets filled with excellent samples, and used wisely.

 

[starryeyes]

The BioBank study criteria clearly and specifically state that a subject MUST have a diagnosis under the Fukuda or Canadian case definitions by one of the four doctors listed (Bateman, Gluckman, Klimas or Lapp). Idiopathic fatigue, by definition, would not meet the stated BioBank study criteria.

I'm very pleased about that.

 

[justinreilly]

Check the Blood: Think of this: the Light's are doing the exercise studies right now. They're taking blood before and after people exercise and they just looked at cytokines and found something in the more severely ill patients but not in the less ill patients. Suppose someone comes along in a year or two and says "I know what's going on, its not the cytokines" that are really causing people pain its an different immune factor".

All they have to do is check the blood in the biobank. They don't have to enroll patients in another exercise study, have them get on that expensive bike, etc. -all they have to do is check the blood in the biobank! They don't need a $200,000 grant, They don't a year to get a grant proposal together and another year to get it funded. All they need to do is get permission to check the blood! This is dynamite stuff.

Want to know if XMRV is more active after patients exercise - check the blood!
Want to know if HHV6 is more active? - check the blood!

So, are you saying that when a researcher does a study, she can store blood from the study at the bio-bank for future use? If so, this is great. Anything to reduce hassle, costs and especially study subjects having to exercise would be most welcome!

It's helpful for everyone but its perfect for small research efforts without alot of money - like the CAA's and MERUK's and other organization - who need to cut corners wherever they can. These are the groups that are doing the most creative research.

The bio-bank generally sounds like a great project. Kudos to CAA for this.

 

[Cort]

That's my understanding. The WPI did just this with XMRV. They have their sample repository - they had samples from doctors across the country - they simply took out the samples and tested them and they were off to the races.

Here's the genetic alliance biobank site: http://biobank.org/english/view.asp?x=1

I wonder if these are somewhat different projects, though. Maybe my understanding of the biobanks is different. I thought they just needed a freezer and a place to keep the information on the sample. That's what I think the WPI has (?). I must be missing something given the $450 cost per sample.

The Genetic Alliance is all about working with non-profits

The Genetic Alliance BioBank, a centralized, registry and sample repository that enables translational genomic research, was founded in 2003 by leaders in the disease research advocacy field. It was based on a proof of concept, single condition bank that has operated with excellent outcomes since 1995. It operates as a cooperative venture, extensible and responsive to the needs of the nonprofits engaged in the endeavor. The BioBank provides infrastructure for disease advocacy organizations to pursue sophisticated, novel research collaborations with academia and industry to develop new diagnostics and therapeutics to better understand and treat disease.

 

[Cort]

I guess it is more about simply putting a sample in a freezer. Here's what they do:
through

• Provides clinical data collection system with customizable, web-based interface for participant data entry. Controlled SNOMED vocabulary and minimum data sets provide enhanced data mining opportunities.
• Provides web-applications for ease of sample and data management by the member advocacy organization.
• Provides state-of-the-art storage facility and systems for collection, processing, archiving and distributing biological samples. Offers a la cart genetic and genomic analysis.
• Provides training and mentoring to disease advocacy organizations by experts in BioBanking1 and templates for all necessary documents and protocols.
• Provides tools for disease advocacy organizations to recruit participants to the BioBank, using state-of-the art methods that emphasize trust, privacy protections, data security, empowerment of participants and the member advocacy groups, and ongoing education.2
• Provides a robust and dynamic process for informed donor decision-making, leading to truly informed consent, tailored to specific uses of the samples and related information.
• Provides a robust data mining system for querying and visualizing donor statistics and samples for cohort development.
• Facilitates collaboration between advocacy organization, academic, government and industry partners.3

Data Mining is certainly very important - key, really, if you want to get a lot more bang for your buck. As the biobank grows and the data increases it gets ever easier and easier to dig into it and say see if X subset with these abnormalities exists exists (how XMRV patients are different?).

 

[Cort]

You also get this:

Now, an innovative partnership between the Genetic Alliance BioBank and Gene Logic offers not only a reason to hope, but a way to contribute to a cure. By collaborating through the BioBank, patient advocacy organizations have the capacity to leverage the services of Gene Logic, a leading biorepository and data management firm, to host and manage thousands of DNA and tissue samples donated from patients and their supporters from around the country. Member organizations of the BioBank have established rigorous standards to allow qualified researchers to access the samples for use in approved studies, advancing the possibility of a cure for these diseases.

Data management/mining is particularly important in CFS because researchers are looking at so many different body systems (lots of different types of data) and there are probably so many different types of patients. One of the big 'holes' in CFS research are really large studies (lots of patients) that do alot of tests (lots of data) on which researchers could use statistical analyses to see which groups popout. There may be a viral group (XMRV), an neuroendocrine group, a metabolic group, etc. The way I see as the databank in the Bio Bank grows it itself becomes a very, very large study that data mining specialists can dig into to discern patterns (different groups of patients). The ability to datamine is crucial in kind of amorphous, not really well-defined diseases like CFS.

Just think if you can define a viral group. Once you do that all of sudden your study results get much more positive because you don't have these other patients in their mucking up the study. Doing this is a big key to learning about our disease.

Gene Logic appears to give them the ability to look at gene expression. When you're looking at tens of thousands of genes you have tons and tons of data.

The addition of data management capability for the BioBank will accelerate translation,” said GA BioBank™ founding President Sharon Terry, “Partnering with Gene Logic provides us with expertise in sample and information management. We know that novel solutions are necessary, and building lasting communities as stewards of their own samples and data will enable genotype/phenotype correlations, natural history studies, recontact, ethical participation and phase IV studies.

 

[Cort]

Here the members of the Biobank are:

http://www.biobank.org/english/View.asp?x=1392

• CFIDS Association of America
  
• Inflammatory Breast Cancer Research Foundation
  
• Joubert Syndrome Foundation
  
• National Psoriasis Foundation
  
• PXE International
  
• US Hereditary Angioedema Association

 

[creekfeet]

My endometrial tissue will be going to WPI. :Retro smile:

I hope the SolveCFS BioBank gets ample numbers of samples, but it would be great if they could identify some funding for phlebotomist housecalls, to make it easier for the housebound and/or uninsured to send samples.

The problem of accepting samples from the patients of only certain doctors wouldn't exist if reasonable diagnostic criteria were followed by all doctors... and won't exist when someday all doctors make reasonable diagnoses because clear test(s) for ME/CFS(s) have been developed, partly through research such as will be conducted using these very samples. Cycling viciously, but closer to a breakthrough all the time.

Sci Fi Time: Suppose there are very distinct regional varieties of what has been lumped together as ME/CFS, and even different varieties infecting different socio-economic classes? Think what could remain unfound, as those with insurance and proximity to the right doctors are sampled, and the rest aren't.

 

[jspotila]

The Association fully anticipates that the BioBank will evolve and expand over time. We hope to involve more clinicians in identifying patients using the proper criteria. We hope to have funding for home phlebotomy services. As our resources grow, we will invest more in the BioBank. We want the BioBank to be around for a very long time. This week's announcement is our first roll out; we are doing everything in our power to ensure that it can grow.