2022 INIM Conference - Q&A Transcript
Does using pre-meds before vaccine reduce efficacy of producing antibodies? is Allegra OK over benadryl?
Mast cell focused drugs do not change your response to the vaccine - antihistamines and mast cell stabilizers EXCEPT steroids - the worlds best mast cell stabilizer.
When you say autoimmune flare-up from vaccine is that for a few days or could be months long?
Mostly they have been very short lived - a week, maybe two. But, we have 6 patients (of hundreds) that had a flare that has lasted for months. One that has not gotten back to baseline.
Dr. Klimas, thank you for you and your institute’s work on ME/CFS! With respect to vaccines, should one take the meds/supplements you note help reduce the risk of a flare AFTER taking the vaccine and a flare is in process?
Prevention works best - take the stabilizers for at least a few days before the vaccine is better) antihistamines the day of (before vaccination) and for several days after.
Will the PASC with ME/CFS comparator trials be generalizable to other post-infection fatiguing illnesses, or will they need their own studies?
It depends on what you mean. Post Lyme is often included in the ME/CFS research - we would need enough post lyme in the cohort to see if it's comparable. The NIH deep phenotyping study included a post Lyme group so we should at least be able to compare to that. Also, I didn't mention that the NIH is doing a deep phenotyping now on long COVID, so they should be able to compare that data to the recently completed NIH Deep Phenotyping study on ME/CFS.
How long until diagnostics can be expected for individuals outside the US? How would you recommend to go about a possible patient to receive or rule out a diagnosis?
Some labs such as Great Plains Lab already have branches in Europe. Please check online.
Dr. Rey, with respect to toxic load, does living in an area with naturally-high radium (e.g., the ‘radium belt’ in U.S.) impact ME/CFS and/or mast-cell issues?
I would suspect so. I haven't treated anyone with radium toxicity; however, other members of the American Academy of Environmental Medicine that live/practice in those areas have presented case reports on radium impacted patients.
Have both ME/CFS since 2009 and Von Willebrands disease. Does your research look into potential ME/CFS treatments vs impact on bleeding disorders?
This is where "personalized medicine" is so important. And, also, how much we struggle when we design studies to be inclusive but, also, have a design that can answer import questions for subgroups of people with these illnesses. So usually at phase 1 (the small numbers, everyone treated with the point of showing safety and feasibility) we are pretty restrictive in the criteria. When it moves to phase 2 and phase 3 (large or very large numbers ), we can do this sort of subgroup analysis to see if the safety and efficacy (did it work) is seen in people with other conditions. Long answer for saying: it depends on where we are in the trial - early or late.
Thank you Dr. Klimas for all you have done and continue to do for the ME/CFS community. If I understood you correctly, you will either have results or will be doing a major trial at the end of August which will yield 'curative' treatment. (Prayers said and everything crossed!) I have been housebound since May 2021. IF treatment becomes available through your studies, will my PCP be able to prescribe for me?
We will be starting this study. It follows a decade of bench science to lead to this study. It is currently entirely funded by private donations, so we will be limited to doing what we can afford. We have applied for federal funding. We also want to do this sort of modeling in long covid and we are applying for that as well.
Dr. Rozenfeld, is there any relationship between - or are any studies being done related to - ME/CFS and Parkinson’s?
Good question, I do not think there are studies connecting ME/CFS and Parkinsons.
Will Dr. Tanio consider taking medicare for patients unable to hold a full-time job?
I can't speak for Dr. Tanio, but the NSU HealthCare System has a way to reduce costs for financial hardship patients - there is some paperwork, but the office manager can walk you through it.
Are there any studies utilizing veterans available for hyperbaric or light therapy?
We have a veteran study underway with hyperbarics for Gulf War illness, the same group does Traumatic Brain Injury repair research. We are anxious to raise the funds to have an onsite hyperbaric unit so we can offer this clinically as well as a research tool.
How do we volunteer for clinical trials? Is there an age restriction?
If you’d like to volunteer for clinical trials, please contact Zachary Barnes: zb84@nova.edu | office - (305)575-7000 ext. 14217 Cell - (617)435-5634.
If you are eating probiotic rich foods, does that eliminate you from the Kaneka Probiotic Study?
No - so long as you don't change what you eat during the study period.
Thank you all so much for your presentations and work! What can be done to improve the time lag between research and the implementation of key findings by physicians and patients?
Our biggest problem now is recruitment - a big surprise, since pre-pandemic people were so hungry for answers it really wasn't as big an issue. But, the time it takes to do each step is limited by recruitment - we have been recruiting the long COVID study (COVID UPP) since last Fall, we have sent out 20,000 plus emails and about 1% even click the link to see what we are trying to do. We really need help so we can move on to the next step.
Dr. Klimas, are long COVID patients being tested for polyclonal hypergammaglobulinemia which is seen in ME/CFS; low blood volumes also found in ME/CFS; or genetic interferon signatures?
The research answer is yes on all counts. The patient assessment should include the studies of gammaglobulin levels and clonality; we also use blood volume as a clinical measure when we have trouble getting the dysautonomia under control; genetic interferon signatures is research right now. But, we do clinically measure cytokine panels to better understand what is going on in ME/CFS and in long COVID. People coming into the long COVID study will have this done for free!
For Dr. Rey - your thought on causality vs. correlation on mycotoxins and ME/CFS?
I think it's part of the cause and, therefore, try to diagnose and treat mold toxicity in all ME/CFS, GWI and long COVID patients I treat.
Thank you, Dr. Klimas. I hope and pray federal funding becomes available. Do you have any kind of timeline as to when we might expect some kind of update(s)?
If we are successful in getting this study off the ground this summer (and we should), we should have answers about this time next year. If its promising we would then move to a larger phase 2 placebo-control study.
I'll be 65 next month (been ill 15 years in December), so not sure if I will benefit, but very hopeful for the younger patients of this population.
All that we have learned about ME/CFS informs our current treatment protocols. The research we do hopes to help set guidelines nationally and internationally, but all of the knowledge we have learned to date informs our treatment protocols.