Session 1 Vaccine Safety Science

Session Chair: Christina Hildebrand

Debra Gambrell, D.O., West County Osteopathy Vaccines and Anesthetics

What can we learn from looking at these two areas of medicine, side-by-side? The specialty of anesthesia comes with well-known risks to neurologic, hepatic, and renal development. There is ongoing research into the neurologic effects of anesthetic agents in children. How does the process of anesthesia compare to vaccination? Is there a way by looking at the mechanisms of anesthetic injury, that we can find these same mechanisms of injury with vaccination? Is there a way to mitigate these risks? Having watched thousands of children undergo anesthesia, of which hundreds have been unvaccinated, I have noticed a normal physiologic trend that is absent in vaccinated children. These children respond differently than unvaccinated children. I am currently designing a study to look at these parameters more closely. If the field of anesthesia hasn't accepted the idea that "The science is settled," why should the field of vaccine science?

Kimberly Liang, MD, University of Pittsburgh

Lupus Nephritis Presenting as Nephrotic Syndrome After Influenza Vaccination

Lupus nephritis (LN) is a severe end-organ manifestation of systemic lupus erythematosus (SLE). Vaccinations are generally considered safe in SLE as long as disease activity is quiescent, but there have been few case reports of vaccinations preceding SLE and LN flares. We report new-onset LN in formerly stable SLE following influenza vaccination. Patient is a 38 year-old African American female with SLE but no history of LN who was referred for new onset of proteinuria and microscopic hematuria. She had received the flu vaccine in November 2015, at which time she had no protein on urinalysis (UA). UA in February 2016 showed new 300 mg/dL protein and 2 RBC. Random urine protein/creatinine (Cr) ratio was 3.02. Edema increased significantly over the next few weeks. Renal biopsy in March 2016 showed membranous nephropathy with minimally active focal lupus nephritis (Class V +/- Class III (A)). She was treated with prednisone 20-40 mg/day, mycophenolate mofetil (MMF) 3 g/d, hydroxychloroquine, furosemide, spironolactone, lisinopril, and atorvastatin. Due to persistent nephrotic syndrome (7.4 g/day), MMF was switched to oral cyclophosphamide (CYC) in early July 2016. Her proteinuria improved to 3.9 g/day in late July 2016. Due to severe urinary tract infection, cytopenias, alopecia, and nausea, she discontinued CYC in September 2016. Proteinuria remained 2 g/day in November 2016, when she was started on azathioprine. Previous studies have shown that SLE disease activity is generally stable after influenza vaccination over a period of 1 month to 20 weeks of follow-up. However, some cases of increased SLE disease activity, flares of pre-existing LN, increased autoantibody titers, and onset of other autoimmune conditions following influenza vaccination have been reported. This case also supports a potential association between influenza vaccination and new onset of LN in a stable SLE patient. There is a need for increased awareness that vaccinations may be potential triggers for LN onset, and further research in this area is warranted.

Judy Mikovits - M.A.R.C., Inc.

Vaccine Components and Host Interactions: Genetics, Epigenetics, Antigenic Load and Compromised Immunity

The one size fits all concept of western vaccination paradigms began when little or nothing was known about T cell and innate immunity. Moreover, only recently were microbiota considered active participants in the immune response. Dysregulation of crosstalk between the developing immune system and the brain is now realized to be central to neuroimmune disease pathogenesis. The data explosion from immunobiology research shows that immune related adverse events inform all vaccinology. Abandonment of the current archaic strategy for vaccinology and vaccine development is long overdue. High content technologies for genomics, epigenomics, transcriptomics, immune and microbiome profiling should be utilized for increased safety and efficacy. The elimination of toxins in vaccine components and identification of hosts with genetic and immune susceptibilities to vaccines are attainable. In this chapter, our focus is on predictive factors of response and toxicity of the host rather than on individual agents.'

Speaker Panel Q/A

Session 2 Vaccine Law 

Alan Phillips, J.D. (Session Chair)

My presentation will review 1) vaccine politics (documented facts raising legitimate, serious questions about current vaccine policy & law); 2) the Vaccine Injury Compensation Program and Vaccine Adverse Events Reporting System; 3) vaccine exemptions in over a dozen different exemption contexts and subcontexts (e.g., vaccines required at birth; for daycare, school & college enrollment; as a condition of employment; for military members, families, schools and civilian contractors in all branches of the military; for immigrants, including foreign-adopted children; for children in child custody disputes (divorce, etc.); for international travel; and other situations in the U.S.; and 4) current vaccine legislative concerns types of vaccine bills and why some pharmaceutical exemption bills and current exemption laws are unconstitutional, and what to do about that; what bills are needed to promote a vaccine informed-choice agenda; and how to strengthen pro-informed-agenda legislative activism to enhance prospects of success against the massive pharmaceutical lobby.

Ginger Taylor, MSc

The Failure to Recognize, Evaluate,Treat and Compensate Vaccine Injury: The Case of Maine

The 1986 National Childhood Vaccine Injury Act (NCVIA) grants liability protection to the vaccine industry in cases of vaccine injury or death, thus morphing the US National Immunization Program (NIP) into an unaccountable entity. Parents have complained for decades of false safety claims made by vaccine interests, of serious adverse vaccine reactions left undiagnosed, untreated and uncompensated in their family members, and of revelations of fraud in vaccine research. As a result of the removal this accountability mechanism, there remains little means by which vaccine injury families, and those concerned with the safety of the NIP, can access accurate information about the program, true risk analysis of vaccines, and even what individual physicians know about the products they are administering. In 2015, rather than engaging with the public or instituting reforms, the vaccine industry and their partners in public health launched an aggressive legislative agenda to introduce more than 100 bills in US states to restrict and remove vaccine exemptions rights. Five vaccine bills were proposed in Maine in 2015, which afforded a rare window into the Maine Vaccine Program, its participating individuals and organizations, and their lack of knowledge on the existence of the VICP that was designed to replace their legal liability and serve their vaccine injured patients. We will discuss the specifics of the response by vaccine interests to parental advocacy to institute measures to educate physicians on the VICP and vaccine package insert information, to hold medical entities accountable for vaccine safety claims, and to implement standard of care assessments and treatment for HHS established vaccine adverse reactions. The failures in patient care due to the effects of the NCVIA are more easily mapped in a small state like Maine, but likely represent the state of vaccine safety and injury practices in all US States.

Speaker Panel Q/A

Session 3 Post-Vaccine Therapies

Dr. Ted Fogarty (Session Chair)

Session Overview: 

Dr. Fogarty will be coordinating the themes of a superficially disparate group of speakers via cognitive and imaging diagnostics in a fashion that ultimately makes economic sense for population health proponents as well as health freedom advocates.  Follow the money through the environmental medical journey of the speakers in this session with Dr. Fogarty.  From the best use of psychologists’ time in the trenches as described by Steve Kossor to the rapid resolution of acute encephalopathy by the approach of Dr. Daphne Denham to acute concussion, this session will get you thinking!  As we discuss imaging biomarkers and laboratory methods identified for response to interventions we can plan the future of cutting edge neurological care in the acute outpatient setting as well as see how its already being practiced by gifted clinicians.  Dr. Ken Stoller adds a specific tie to the hyperbaric medical approach to chronic encephalopathy induced by HPV vaccination and Dr. Christian Bogner wraps up the session with an evolutionary approach of tapping cannaboid receptors as part of a greater whole-person treatment of autism.  Peppered through the session in between these great speakers will be introductions and ethical/economic cost/policy points being made by Dr. Fogarty derived from his concept of Ethical Vaccinomics, understanding of the genetic and environmental causes of autism, evolutionary medicine as coded in DNA responsiveness to pressure, oxygen and the glutathione system.  Data mining from neuroradiology in selected case reports and clinical studies he has been a part of will fill in the mortar points for these great foundations of medicine in this integrative breakout.

Dr. Ken Stoller, MD

Hyperbaric Oxygen in Treating HPV Vaccine-Induced Encephalopathy

Since the HPV vaccine was introduced in 2006, I have had the opportunity to treat the untoward neurological sequalae of this vaccine in several teen girls; although, one child actually died before she could be treated. Hyperbaric oxygen has been shown to down regulate inappropriate immune responses as well as rehabilitate neuronal damage from any number of sources. Symptoms range from constant headaches, joint inflammation and other autoimmune symptoms, severe cognitive and behavioral abnormalities, and ovarian failure. In one case, documented by serial neurocognitive testing, a teenager with probable anti-NMDA encephalitis triggered by her HPV vaccine was treated with hyperbaric oxygen and showed dramatic improvements in all neurocognitive indices. Hyperbaric oxygen in known to activate thousands of genes and facilitate mitochondrial biogenesis, and mitochondrial rehabilitation is probably the mechanism at work just as it is in treating post-polio syndrome utilizing hyperbaric oxygen.

Steven Kossor - The Institute for Behavior Change

Treatment Outcome Measurement & Treatment Funding

A system for measuring treatment outcomes for behavioral health treatment programs has been tested for more than 20 years by independent researchers from four different educational institutions. All of these researchers found that treatment outcome measures supplied by the recipients of treatment services (or their parents, if the recipient was a minor) were instrumental in obtaining and maintaining treatment funding in a Managed Care environment. Treatment periods in excess of three years were reliably funded through the use of the system in four Pennsylvania counties, despite vigorous challenges presented by Managed Care Organizations and others who benefit when treatment is dispersed over a large population with relatively little treatment being delivered to any particular individual. The system is efficient in its administration (less than 15 minutes per week), clinically sophisticated (a 10 point annotated Likert scale with benchmarks and explicit rating criteria), with extremely high reliability through the use of a single subject with repeated measures experimental design with hierarchical linear modeling as one of several applicable analytic procedures. The results of the four independent analyses will be presented with opportunity for discussion of necessary precautions to reduce or eliminate sources of error variance including rater malingering and bias.

Christian Bogner, MD, FACOG - Beaumont Hospital System, Detroit, MI

Vaccines, Autism and Cannabis

Autism is a worldwide epidemic. Many parents report a regression of their child after certain vaccines. Until today, mainstream medicine claims there is no link between autism and vaccines. Many scientists bring together novel concepts from thousands of scientific research papers and present a breakthrough understanding into the complex disease mechanism. Autism is a neuro-inflammatory disorder involving specialized cells in your brain called microglia. These immune surveillance cells act as guardians of the brain environment. Depending on the signal they receive, they can be neurotoxic. These cells, however, may also be anti-inflammatory and aid in shaping of new neuronal circuitry. Vaccines, agricultural chemicals as well as genetics are the core focus of microglial activation. We will explore how these cells respond to insults and how we can attempt to send signals to witness their paradox abilities leading to neurochemical homeostasis.

Speaker Panel Q/A

Session 4 HPV Vaccine and the Law 

Chairperson: Kim Mack Rosenberg

TBA

Distribution of Mechanisms of Pathogenesis Across HPV Clades: Implications for Public Health Policies

Robert Ricketson, MD - The Institute for Pure and Applied Knowledge

In this study, we are focused on three aims: to identify the genetic basis of molecular pathogenesis, including oncogenesis, in human papillomavirus; to map the distribution of mechanisms of pathogenesis across the >104 HPV types, only nine of which are targeted by HPV vaccines, and to consider the implications of our findings for public health policy related to partial immunization given that type replacement occurs in the HPV-vaccinated population. The implications of the study may offer alternative intervention strategies directed towards RNA splicing in HPV to reduce the incidence of cervical intraepithelial neoplasia. We are exploring a strategy in which a 3' acceptor splice site is inserted to inhibit reinitiation of translation of E7. Another intervention would be to target the common promoter located upstream from E6 since HPV is transcribed to a single pre-mRNA and then subjected to splicing. Knockout of the promotor would, in theory, knockout both E6 directed p53 ubiquination and E7 interaction with retinoblastoma protein (RBp). That way both transformation and proliferation would be prevented.

Speaker Panel Q/A