CRBAI Fundraiser for VIP
Dear Friend of CRBAI and Surviving Mold,
Over the past 17 years, you may have received a fund raising letter from the Center for Research in Biotoxin Associated Illnesses (CRBAI), the 501-c-3 non-profit research arm of Dr. Shoemaker and Surviving Mold. To date, over $2 million has been donated for research-very penny has gone to clinical studies. Our database on chronic inflammatory response syndrome (CIRS) is incredibly broad-based, thanks to your help. From HLA to NeuroQuant and TGF beta-1 to VIP, over 20 studies on human health effects from biotoxins have been funded (all or in part) by CRBAI. If you or someone you love has personally benefited from the prior work of Dr. Shoemaker in diagnosing and treating chronic inflammatory response syndromes (CIRS), then you know the importance of the work of CIRS physicians. Our work could not have happened without your help.
In the past, it was just Dr. Shoemaker who asked for donations. Now the entire steering committee of Surviving Mold stands united with this new and most urgent request for support. To save the use of VIP, we must ACT NOW to be able to file and obtain an Indication for New Drug (IND) use for VIP. Just the fees from the FDA for are nearly $2.4 million. We have completed the pharmaceutics required for the IND but face costs for animal studies and attorneys, to name a few. We need $5 million. No kidding.
The VIP Story: After the fungal meningitis disaster (60 deaths) caused by contaminated injectable steroids made and sold by a compounding pharmacy in 2012, Federal response included making new laws (Drug Quality and Security Act, Public Law 113-54, passed 11/27/2013) that provided oversight and regulatory power for the FDA over all compounding pharmacies and all compounded medications.
VIP is one such medication. In 2014, CRBAI provided support for and submitted a brief to the FDA on behalf of Hopkinton Drug, the only pharmacy compounding VIP at that time. There are now at least three pharmacies making VIP. Since 2008, we know of 354 physicians who have prescribed VIP with over 7000 patient refills. The drug has brought hope to hundreds and essentially a normal life to so many.
At the 11/3/2106 FDA hearing on whether or not to put VIP on the “May Compound List,” the pre-meeting Federal consensus was NO, but due to the strength of our data, the consensus was changed to “submit an IND.” Without an IND, we lose VIP as treatment.
Your past donations have directly impacted patient care, especially treatment with VIP. Because of your generosity, we have funded research leading to these new findings:
• VIP fixes gene regulation: Genomic testing, looking at differential gene activity, not just SNPs, shows that when regulation of gene activity is dysfunctional as routinely is found in CIRS, the vital activity of protein manufacture by ribosomes and creation of ATP for energy by mitochondria is incredibly affected. VIP fixes this gene regulation gone haywire! Read the paper here, and view the gene expression figures here. Our research, presented in November, 2015, is ahead of NIH-funded genomics CFS research (final report due December, 2018; cost $18 million). This genomic testing (Next Generation Sequencing; transcriptomics) can be done by physician order through Surviving Mold.
• VIP fixes the brain: Even more exciting is the finding that treatment with VIP corrects the atrophy (shrinking) of specific brain regions (grey matter nuclei) shown on NeuroQuant caused by CIRS. We have shown that the inflammation, causing neurologic injury that causes symptoms, is reversible! A new approach to Alzheimer’s just down the road! This study likely be published this month.
• Studying the genomics of brain injury (and repair): We are beginning a multi-site clinical trial that will look at genomics before and after correction of NeuroQuant deficits in CIRS. This unique study is designed to identify the genomics of brain injury and repair.
Over the past year we have accomplished much:
• 10 additional medical providers became certified in the CIRS protocol and 25 more have begun the certification process
• 2 additional papers were published on CIRS
• Two conferences were held:
o The Third Annual State of the Art CIRS Conference, held in Irvine, California in October, 2016.
o A Virtual Conference was held in Fort Worth, Texas in April, 2016.
As you can see, we’ve been busy over the past year, but have so much more work to do. Please consider a tax deductible donation at one of the following levels:
__ $100 will pay for one hour of statistical analysis.
__ $500 will pay for NeuroQuant analysis. Make a donation of this level and receive a copy of the Third Annual State of the art in CIRS Conference DVD
__$1500 will pay for one PAX gene tube testing. Donate at this level and receive a 30-minute discussion with one of our senior physicians (Drs. Mary Ackerley, Keith Berndtson, Scott McMahon, Sonia Rapaport, and our very own, Ritchie Shoemaker).
__$5000 will pay for one CIRS-physician-in-training to study with a certified physician. Donate at this level and receive before and after genomics studies (two genomic tests).
__$10,000 will pay for 20 analyses of depurination of the ribosomal sarcin-ricin loop (it is in the RNA-seq paper). Donors at this level will receive five genomic tests.
__$50,000 will pay for a published paper. Our generous donors at this level will receive public recognition of support in the paper.
Please send your generous donation today to CRBAI, 500 Market St, Pocomoke, MD 21851. Your support is urgently needed.
We wish you the very best health and with your help, look forward to reporting new advances next year.
Sonia Rapaport MD;
Mary Ackerley MD;
Scott McMahon MD,
Keith Berndtson MD
Ritchie Shoemaker MD
Contact Debbie Waidner at 410-957-1550 for more information.