As many of you know, there has been concern in the chronic inflammatory response syndrome (CIRS) community regarding the recent publication from the FDA (9/4/19) stating that the FDA will not include VIP on the registry of drugs that may be compounded. This decision is in follow up to a similar opinion from February 2019, which in turn was the result of a decision made by the FDA, November 3, 2016 to remove VIP from a list of drugs that can be compounded.
VIP was first used in CIRS patients in November, 2008. Its use has revolutionized care of CIRS in that not only does VIP correct symptoms and proteomics seen in affected patients, but it also corrects gray matter nuclear atrophy (think of early Alzheimer’s!) and the transcriptomic (gene activation and suppression) abnormalities that are the ultimate source of this illness. Without VIP, patients will be forced to either suffer needlessly (this illness can kill people too) or search for another neuroregulatory peptide that can safely reproduce the extraordinary benefits of VIP.
In the years since VIP was first used, it has been estimated that over 1000 physicians have prescribed VIP as a nasal spray for over 10,000 patients from at least five pharmacies. VIP has an impeccable safety record. For best results, we suggest that published criteria for safe use of VIP be followed.
What can we do to stop this proposed regulatory change? There are three different approaches that potentially could maintain current usage status of VIP.
An organized campaign of letter writing to the FDA from providers and patients alike needs to begin. We have 90 days to comment on the adverse effects that would befall patients were VIP removed from public use. The FDA will read and note each issue raised in public commentary. For every statement made to the FDA, a copy should be maintained in a master file. Temporarily, that file will be held in the office for The Center for Research on Biotoxin Associated Illnesses, 500 Market Street, Suite 103, Pocomoke City, 21851. Debbie Waidner (410-957-1550, M-F) can help answer questions.
It is possible that the time period between the FDA’s announcement of action planned versus the actual action will permit ongoing use of VIP, including current patients.
It is also possible that the scientific, clinical and manufacturing data required by the FDA that is now being collated will convince the FDA to (i) issue a waiver of user fees needed to pursue an IND; (ii) issue an acceptance of the three published papers on use of VIP in CIRS patients as adequate to satisfy requirements for approval of Phase 1 status; and (iii) lay the groundwork for Phase 2 clinical trials. Application for an IND for Phase 2 trials would be submitted with request for approval of Phase 1.
It is more likely that the FDA will continue to suggest application for an IND as they did at the end of the November 3, 2016 meeting. Our data then supported the contention that VIP has a role in treatment of chronic fatiguing illness. This concept is especially well shown with transcriptomic studies in published, IRB-approved trials. We know the procedures the FDA requires for an IND. They are detailed and must be followed. We have begun the effort to respond to the FDA with over 2000 pages of published materials and exhibits collected this week. There is much more to do.
To that end, we have made arrangements to consult with an FDA expert, Dr. John Schaefer, an individual who has 40 years of experience working with pharmaceutical companies and other groups to shepherd our IND application correctly.
If we are to successfully obtain FDA approval, we need to raise a lot of money. The IND process is expensive. We have a 501-c-(3), a non-profit organization, The Center for Research on Biotoxin Associated Illnesses, willing to funnel earmarked donations to support the IND work. Donations are charitable and are eligible for tax benefits. We realistically need $100,000 just to get started. If our application is not detailed and thorough, we will fail. All donations are used to fund the IND process without any administrative fees.
VIP has been documented to improve the quality of life enormously in desperately ill patients. We can not afford to lose use of VIP! Please donate to CRBAI with an earmark “FDA-VIP-IND process.” If we are successful with the initial phases of application, we must be ready to raise much larger amounts of additional capital in the future.
Please make a comment (exact information on comments is forthcoming). Please make a donation!
Ritchie C. Shoemaker, M.D.