Member questions for Dr. Sadie Whittaker, new Chief Scientific Officer of Solve ME/CFS Initiative

A recent editorial from Dr Whittaker
I am honored to be a part of the ME/CFS community and I am so pleased to be writing my first editorial in Research 1st.

While new to this disease, I have spent many years working in the fields of biotech, clinical development, healthcare advocacy and policy, and public health strategy. I know that experience can be applied to drive towards the goal of making ME/CFS understood, diagnosable and treatable.

There are two areas I’d like to focus on from a research standpoint: first, how do we meaningfully integrate those who know most about this disease – patients – into everything we’re doing, whether that’s tailoring how we communicate about our research to better meet patient needs, or by integrating patients into the review panel for our Ramsay Awards. Second, how can we collaborate as an organization, and foster collaboration among the researchers we fund, to succeed faster.
Click to expand...
https://solvecfs.org/june-2018-research-1st-reflections-from-dr-whittaker/
 
Last edited:
Dr Whittaker answering a question on Facebook
Dr. Whittaker answered your questions from Facebook. The first question comes from Fiona who asked “whether it's mitochondrial dysfunction, autonomic nervous system dysfunction or immune dysregulation, all the key features of ME/CFS involve the hypothalamus. Why aren't researchers looking into this more extensively?”

From Dr. Whittaker:
Hi Fiona, thank you for starting a discussion on hypothalamic dysfunction. There has been some work to explore the influence of the HPA (hypothalamic-pituitary-adrenal) axis, a stress-response system, in ME/CFS. HPA dysregulation does appear to be associated with ME/CFS, but we don’t have evidence of a causal role. However, there is interest in expanding knowledge in this area and developing treatments based on this target. For example, Dr. Nancy Klimas and her group at the Institute for Neuro Immune Medicine have put forward research suggesting a role for the HPA axis, HPG (hypothalamic-pituitary-gonadal) axis, and the immune system in perpetuating or regulating both Gulf War Illness (GWI) and ME/CFS. They are now exploring this model in a clinical trial.
Click to expand...
https://www.facebook.com/SolveMECFSInitiative/posts/10155554960477108:0
 
Most patients will meet either the IOM or CCC criteria but there are some that meet the ICC criteria. Unless they are researched as a disease group of ME patients, how can their very severe neurological issues and infections ever be treated? It seems as if they have gone into neurological meltdown with possibly irreversible damage that would demand its own treatment interventions. Their relentless infections may need a different approach than a patient who only meets IOM or CCC. And if not recognized now, when? Once treatment interventions are developed for SEID and ME/CFS patients, that does not guarantee those interventions will work on those with ME. And drug companies tend to have an adversity to developing specialized drugs and treatments for smaller groups of patients. ME patients are almost an orphan disease within the ME/CFS disease spectrum. I wouldn't think any treatments developed for Asperger would really work for Autism and vice versa.

We don't know for certain if they are really the same diseases (SEID vs ME/CFS vs ME) but could it be they are and are just different types? And like Age-related Macular Degeneration (dry atrophic vs wet neovascular or exudative) can one possibly progress to the other? Over decades I have gone from meeting IOM criteria to CCC. I may be sliding into ICC but it is difficult for me to understand and navigate this criterion.

Also, how do we educate the healthcare system to our allergies to many medications? I have failed on many medications and even supplements due to them drugging me or causing the side effects listed that most "ordinary" patients do not get. Minocycline has given me vertigo which somewhat subsided but definitely left me with dizziness and unsteadiness as well as 24/7 Tinnitus. (My doctor told me ongoing side effects after stopping the drug only happens to about 1% of patients.) How do we get other state's Departments of Health to educate their doctors on ME/CFS like the NY Dept. of Health has done?
 
We also need to educate the healthcare system that using depression and psychotic drugs to help us sleep is not working. They are not helping us sleep and just pretty much drug us during the day. Knocking someone out is not helping them sleep.
 
I visited the SMCI website to remind myself what research SMCI support. I think the website needs some work. The About Us page says
SMCI is the trusted source for up-to-date medical information, current research, and policy development.
Click to expand...

But if you click through on 'Research Programs' you are taken to a page called 'SMCI Science and Discovery Programme - For Researchers'. It says this:
Our 2012 grantees had a research focus on safe and effective treatments.
Click to expand...
There's no following text about what happened in 2013, 2014 and so on. It also gives Zaher Nahle's name as the contact.
I think, given the expressed desire for the participation of patients in research, it is odd to have a page titled 'For Researchers' when you click through from a 'Research Programs' heading.

The Patient Resources page is under construction. Which is at least a sign of movement in the right direction but you'd hope it wouldn't stay that way for long.
The 'About the Disease' page has a picture of a heart symbol held between two hands, with a DNA helix in the middle of the heart. What has that got to do with ME/CFS? What's it trying to tell us - that ME/CFS is a genetically caused heart disease? That we should love and take care of our DNA?

And it says this
Acupuncture, hydrotherapy, yoga, tai chi, and massage therapy have been found to help and are often prescribed for symptom management.
Click to expand...
Which I think is odd, given all the possible things the page could have said that would be more important. Found to help? Really? I think the evidence would be weak. Massage therapy sounds a nice safe thing to do, but I was amazed to find that I was getting 3 day PEM after sessions.

So, there's not really a question for Dr Sadie Whittaker in all of that, but perhaps she might like to take the opportunity, on behalf of SMCI, to tell us what is happening with the website. Perhaps funding research seems a more important use of funds and effort, but if SMCI wants to be credible, with researchers and with patients, a decent website is a good start and doesn't cost a lot.
 
Last edited:
From Dr Whittaker's editorial
https://solvecfs.org/june-2018-research-1st-reflections-from-dr-whittaker/

A big focus for SMCI over the coming months will be the biobank and registry. As I have seen in other diseases, I know that establishing a large body of patient data will drive discovery. I am committed to advancing the biobank and registry in a collaborative a way– this is a global disease so let’s establish a single global biobank and registry of consolidated data that is available for anyone who needs it. I look forward to engaging individuals with ME/CFS and their caregivers to incorporate their knowledge and ensure that the data capture is conducted in a way that addresses their needs.
Click to expand...

A question could be
How is this single global biobank and registry of consolidated data going to work? Do you plan to have just one site in the world where samples are stored? Wouldn't just close collaboration between biobanks and registries be a more achievable aim? Will this planned single global biobank and registry provide coverage of post-Ebola ME/CFS?
 
Thanks for the questions/suggestions so far.

Some bio for Dr Whittaker
Dr. Sadie Whittaker, is the Chief Scientific Officer of Solve ME/CFS Initiative (SMCI). She received her PhD in molecular biology at University of Birmingham, UK, and her BSc in Biochemistry from University of Leeds, UK. She worked first as a medical writer for Amgen before rising to the Director of Clinical Development and finally to US Medical Lead for Biosimilars there. Thereafter, she founded ScienceOne, where she served as CEO.

Dr. Whittaker joined Solve ME/CFS Initiative (SMCI) in May 2018, where she manages the Ramsay grants and serves as SMCI’s liaison with the National Institutes of Health (NIH) Collaborative Research Centers (CRCs) and Data Management Coordination Center (DMCC).
Click to expand...
 
How do we stimulate more research into ME? I see a mix of areas that it would be interesting to have addressed:
  • How do we get more researchers interested in ME?
  • How do we get drug companies interested or at least watching the research?
  • How do we get more funding or what can we do to encourage the generation of high quality research proposals?
 
Thanks Dr. Sadie for taking the time to answer our questions. A major problem we face now that will cause problems down the line needs to be acted upon by NIH. Nancy Klimas is ready to begin clinical trials but there is no mechanism in place for her to do so - she just hasn't the money.. I understand she has funding for a pilot trial but beyond that, there is nothing in place. Likewise, the NIH program announcement (PA) for ME/CFS does not allow funding for clinical trials. That’s something that Dr. Koroshetz said WOULD change, but it hasn’t. Getting that PA to specifically allow grant proposals for clinical trials could clear the way for Nancy Klimas, Ampligen, Cortene and others to apply for funding. So Dr. Klimas is ready to start trials and Dr. Koroshetz is sitting on his hands while our lives continue to pass us by.
What can be done to get NIH to act on this particular issue NOW?? The NIH budget is larger than it's ever been. I think I speak for the majority of ME patients when I say we are so sick of waiting for NIH to take appropriate action. As a speaker said at the recent CFSAC meeting, NIH have dipped their toes in the sea. It's time for them to jump in. That's bringing weird images into my head but you get the gist.
 
Any more questions from anybody?

I'm intending to ask her to give a bit of an overview of her background, and ask whether she feels any of her previous experience can be of particular use in her role with Solve.

I'll also ask if, as someone who is presumably relatively new to the ME field, she feels there are any avenues that aren't currently being followed that could be of use, whether that is in science or any other aspect.
 
Andy said:
I'm not sure she'd know, though obviously I can ask her. Looking at what details we have about her previous work she seems to have a private sector background.
Click to expand...

It's an interesting question by itself and possibly of interest to the SMCI which relies on donations.

If it turns out that we donate more than average, we can include that info in advocacy material to strengthen the message that we really need more government funding.

If it turns out that we donate less than average, we can say that patients should be able to donate more (factoring in the impact of the illness in any comparisons to other illnesses).
 
Perhaps they have already thought of this, but I wonder if their biobank/patient registry has a mechanism to retrieve samples from patients who are in remission. While the system is obviously set up to acquire samples from patients who are ill, they might want to proactively try to acquire and store samples from patients who are in remission - an arguably more difficult task since remissions are relatively rare and may be confined to a "window of opportunity" of uncertain length.

I'm just thinking that a lot might be learned by comparing samples (blood, microbiome, etc.) from the same patient, both while ill and in remission. Patient remissions don't adhere to a timetable, so a mechanism like a biobank seems like it would be well suited to capture this potentially important data. It could be as simple as emailing registered patients and saying "Hey, if you find yourself in remission, CONTACT US!"
 
I would like to hear more about your plans for patient involvement. You said:
There are two areas I’d like to focus on from a research standpoint: first, how do we meaningfully integrate those who know most about this disease – patients – into everything we’re doing, whether that’s tailoring how we communicate about our research to better meet patient needs, or by integrating patients into the review panel for our Ramsay Awards.
Click to expand...

Can you tell us more about your plans for this, in particular will you use social media, such as this forum, and will you find a way to involve people with severe ME?
 
From what I can see looking at the SMCI website it seems the research focus is on finding out more about what is going wrong in ME, and in collating information and samples through data and biobank. This is all great and I wouldn't want any of this to stop.

But there is another area of research too - treatments. As you are probably aware, there are doctors and patients around the world experimenting with different treatments such as antivirals, antiretrovirals, low dose naltrexone, sodium dochloroacetate, assorted nutritional supplements and herbs and diets such as paleo, low carb and keto.

Does Solve see itself anytime supporting/funding any of these being properly researched in small clinical trials which if successful could then look to NIH or drug companies to fund large scale trials?
 
You must log in or register to reply here.
Back
Top Bottom