FDA approves first dietary supplement under new drug application with the indication of serious or life-threatening illnesses

Background: Research began on botanical/herbal organisms to study plant cells. The idea behind this was that plant cells have basic similar actions as do animal cells (i.e., both are Eukaryotic cells). These cells can show what activity is produced from the Technology/Innovation behind ImunStem, without risk to animals or humans, and still retrieve data to verify the theory. By using plants and studying plant cell activity, then later comparing plant cell, animal cells, and human cell responses, it thus shows activity for all cell structures. The activity was also studied from patients taking ImunStem for the indication of Serious or Life-threatening conditions or diseases. Patient medical report results showed an overall improvement in bodily function as blood report results were compared. Patients that were administered ImunStem showed improvement in their overall health and patients with chronic disease had reduced pain as ImunStem was administered over time. The pain was reduced because the body was in the healing process and a reduction in inflammation would occur during healing and the patient's health would improve. ImunStem was produced based on the theory that the product could rejuvenate the cell and bring the cell back to a homeostasis balance. This balance to the cell (through nutrition) can give the surrounding cells a homeostasis balance that may heal cells and tissues in the body. It is believed that the function of a Quantum Wave effect is explained through the discipline of Quantum Mechanics. The Quantum Wave may disrupt the subatomic particles that provide adhesion to allow the product through the cell wall and move to its target location. In Quantum Mechanics, particles have wavelike properties. The Schrodinger equation, for example, governs how these waves behave. Methods: Administration of ImunStem was given to patients in a life-threatening situation where no standard acceptable treatment was available and in which there was not sufficient time to obtain approval from the Institutional Review Board. Results: ImunStem showed positive medical results for patients with Serious or Life-threatening conditions or diseases, which prompted the US Food and Drug Administration (FDA) to move forward so patients could be provided treatment that was not otherwise available to them from their physicians/doctors. ImunStem was applied for and received its New Drug Application (NDA) No.: 204701 with the indication of Serious or Life-threatening conditions or diseases and National Drug Code (NDC) No.: 70642-001-01 on July 02, 2018. Golden Sunrise submitted an NDA application on January 07, 2013, November 05, 2018, and April 03, 2020 with a request for FDA Fast Track designation, Breakthrough Therapy designation, Accelerated Approval designation, and Priority Review program process are the pathway allowing the ImunStem product to receive acceptance by the FDA.

Requests for Ivermectin and Healthcare Distrust in the Rural South

INTRODUCTION: The unprecedented nature of the COVID-19 pandemic has led to contentious discourse around issues related to vaccines and unproven COVID-19 therapies (UCTs), such as ivermectin. Despite recommendations against its use, ivermectin remains heavily used, and in some areas, highly demanded. We explored perceptions of patients living in the rural South about UCTs and healthcare distrust. METHOD(S): This mixed methods study was conducted from 2021-2022 in Moultrie, Georgia. Adult patients with a history of COVID-19 were recruited from inpatient and outpatient settings of a healthcare system. Validated phone questionnaires assessing healthcare distrust and a 30-minute qualitative interview exploring healthcare trust, perceptions of UCTs, and evidence-based therapies (eg monoclonal antibodies and vaccines) were conducted. Thematic analysis was applied to transcripts. Nonparametric independent samples Mann-Whitney U tests used conducted to compare survey means (95% CI). RESULT(S): We recruited 26 patients (62% female, 85% white). Eight themes emerged: 1) Anecdotal stories and personal experiences influence decision-making about COVID-19;2) Use of a haphazard approach to ;research';3) Strong distrust of national government and healthcare organizations;4) Strong trust in local doctors and the local health system;5) Decision-making is viewed as weighing pros and cons;6) Lack of consistency in COVID-19 related medication decisions (eg ivermectin, monoclonal antibodies, remdesivir);and 7) Patients value autonomous decisions about their healthcare and feel they have a right to try medications (knowing possible risks). High survey means indicated high distrust;healthcare distrust mean scores of those who requested/used ivermectin versus those who did not had a mean difference of 7.1 points (p=0.027). CONCLUSION(S): Although trust of healthcare and government was low, trust in local physicians was high. Patients value the right to try ivermectin, this desire was fueled by distrust of government. If clinicians are perceived as aligned with the government, such alignment may void trust of clinicians. Health messages should invoke patient autonomy and be framed as presenting options (including pros/cons) and should balance patient autonomy with clinicians' ethical parameters around unproven medical treatments.

Clinician Experiences Related to Requests for Ivermectin and Healthcare Distrust in the Rural South

INTRODUCTION: Ivermectin has been widely requested or prescribed as treatment for COVID-19 despite NIH and WHO recommendations against its use. Even so, clinicians commonly receive requests for unproven COVID-19 therapies (UCTs) and face substantial disruption to the therapeutic alliance when clinicians deny these requests from patients. METHOD(S): This study was conducted from 2021-2022 in Moultrie, Georgia. Physicians or advanced practice clinicians who treated a COVID-19-positive patient in the health system were eligible. Purposive, convenience sampling was used to recruit clinicians to participate in a 30-minute qualitative interview exploring experiences and thoughts related to UCT requests, patient trust in the healthcare system, and personal impact of distrust and UCT requests. Thematic analysis was applied to transcripts. RESULT(S): Participants were 8 clinicians (7 physicians, 1 advanced practice nurse) from several fields (outpatient setting=2, inpatient or mixed setting=6): pulmonary/critical care (n=3), internal medicine/hospitalists (n=2), nephrology (n=1), and family medicine (n=2). Five themes emerged: 1) Clinicians do not understand why people trust social media and not their clinical expertise;such distrust is hurtful and frustrating;2) Clinicians feel ambivalence about discussions about UCTs and are generally accepting of community beliefs;3) Clinicians perceived that distrust in healthcare originates outside of the healthcare system yet patients exhibit trust within the local healthcare system;4) Clinicians are torn about whether to use UCTs to build trust and rapport;5) Counseling strategies are variable yet clinicians spend significant time focusing on education. CONCLUSION(S): Clinicians experience distress related to perceived patient distrust in their recommendations about COVID-19 vaccination and UCT requests. Some clinicians perceive that acquiescing to UCT requests may help repair therapeutic relationships with minimal harm. Clinician perspectives are aligned with themes from a related study of patient trust and UCT request from the same healthcare system. Taken together, these studies provide insight for clinicians looking to craft savvy and ethical messages that are responsive to patient needs while upholding professional standards in prescribing medications.

Safety of emergency, elective and day case operating during the winter period at East Suffolk and North Essex NHS Foundation Trust: lessons from the outcomes of 4,254 surgical patients from the first COVID-19 wave.

BACKGROUND: There is limited evidence on perioperative outcomes of surgical patients during the COVID-19 pandemic to inform continued operating into the winter period. METHODS: We retrospectively analysed the rate of 30-day COVID-19 transmission and mortality of all surgical patients in the three hospitals in our trust in the East of England during the first lockdown in March 2020. All patients who underwent a swab were swabbed on or 24 hours prior to admission. RESULTS: There were 4,254 patients and an overall 30-day mortality of 0.99%. The excess surgical mortality in our region was 0.29%. There were 39 patients who were COVID-19 positive within 30 days of admission, 12 of whom died. All 12 were emergency admissions with a length of stay longer than 24 hours. There were three deaths among those who underwent day case surgery, one of whom was COVID-19 negative, and the other two were not swabbed but not suspected to have COVID-19. There were two COVID-19 positive elective cases and none in day case elective or emergency surgery. There were no COVID-19 positive deaths in elective or day case surgery. CONCLUSIONS: There was a low rate of COVID-19 transmission and mortality in elective and day case operations. Our data have allowed us to guide patients in the consent process and provided the evidence base to restart elective and day case operating with precautions and regular review. A number of regions will be similarly affected and should perform a review of their data for the winter period and beyond.

Sniffin' Sticks Screening 12 test: Presentation of odours on filter paper improves the recognition rate.

To the Editor: Monitoring of olfactory function and diagnosis of olfactory disorders using the pen-based "Sniffin' Sticks test" is problematic during the SARS-CoV-2 pandemic due to hygienic concerns. The aim of this study was to find out whether the results of olfactory testing obtained by presenting odours on a single-use filter paper is identical to performing the test by presenting the odour pens according to the manufacturer's manual.