October 13th, 2020 3-5PM ET
Tuesday on The Robert Scott Bell Show:
Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant. A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT. Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details. “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a statement. J&J emphasized that so-called adverse events — illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses.
The placebo response: a hidden risk to Covid-19 trials The response to the Covid-19 pandemic by drug and vaccine developers has been swift. BioCentury lists more than 400 unique compounds — small molecules, antibodies, and vaccines — that are currently in clinical development for Covid-19. Yet the success of this work is at risk due to an invisible threat: the placebo response. It could contribute to clinical trial failures and delay the delivery of medications and vaccines to mitigate this global public health disaster. The placebo response is a complex psychobiological phenomenon that describes the clinical improvement seen in patients taking dummy or sham medicines. It can also comprise some proportion of the measured effect among patients receiving active drugs. Multiple behavioral, psychophysiological, and neuroimaging studies have shown that the placebo response is a real, multifactorial effect associated with changes in biochemical pathways in the brain. The effect is patient specific and is influenced by patient expectations and certain well-defined personality traits. While drug developers are attuned to considering the placebo response in areas like pain and depression, it may not be immediately apparent why it is so critical for the development of Covid-19 therapies and vaccines. What set the stage was the FDA’s regulatory guidance, released in May, directing how the biopharma industry should evaluate drugs and vaccines being developed to fight the pandemic.
Medical Doctor Warns that “Bacterial Pneumonias Are on the Rise” from Mask Wearing “A group is suing Tulsa Mayor G.T. Bynum and Tulsa Health Department Executive Director Bruce Dart, saying the city’s mask mandate is harmful to healthy people,” reports Activist Post. The group includes business owners and two doctors who “are asking the city to immediately repeal the mask mandate which was passed by city council last month.” At a press conference, optometrist Robert Zoellner said:“…the fear factor has got to step back. This idea that I don’t want to give you something that I don’t even know that I have is almost at the point of ridiculous. Let’s use some common sense.” Dr. James Meehan, MD followed by warning that mask wearing has “well-known risks that have been well-studied and they’re not being discussed in the risk analysis. “I’m seeing patients that have facial rashes, fungal infections, bacterial infections. Reports coming from my colleagues, all over the world, are suggesting that the bacterial pneumonias are on the rise. “Why might that be? Because untrained members of the public are wearing medical masks, repeatedly… in a non-sterile fashion… They’re becoming contaminated. They’re pulling them off of their car seat, off the rearview mirror, out of their pocket, from their countertop, and they’re reapplying a mask that should be worn fresh and sterile every single time.”
Comment of The Day!
As to the McMaster story, I believe there was a FOIA-type request done to this university and they admitted they had NOT isolated the virus IN THE ORDINARY MEANING OF THE WORD. “Isolation” in the lab does not mean isolate as you or I would understand it. I will find this link for you, because the response letter was posted online over the summer. They admitted they didn’t have an isolated virus in the conventional sense of the word, which means they did NOT. A similar request was made in the UK with similar results. This will be posted and I will link you to the info later on today or tonight.
McMaster researcher plays key role in isolating COVID-19 virus for use in urgent research A McMaster researcher has played a critical role on a small team that has successfully isolated and grown copies of the virus responsible for COVID-19, enabling urgent Canadian research into how it behaves and how it might be controlled. Arinjay Banerjee, a postdoctoral researcher at McMaster’s Institute for Infectious Disease Research, specializes in coronaviruses and in bats, a rare combination that gave him the ideal qualifications to collaborate with colleagues from Sunnybrook Health Sciences Centre and the University of Toronto on the project. The team isolated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the agent responsible for the ongoing outbreak of COVID-19, believed to have jumped to humans from bats. “I’d always told my friends, ‘When I grow up, I want to be a guy who gets called in if there’s an outbreak,’” Banerjee said. “What’s happening with the outbreak is sad, but I’m glad I can contribute to the process of understanding this and controlling this outbreak.” Working at a secure containment facility at the University of Toronto and using samples taken recently from two patients in Canada, the team was able this week to confirm it had isolated and propagated the virus, creating a source of COVID-19 for study as the world races to develop vaccines and treatments, and to build a better understanding of how the virus behaves.
Trump’s Doctor Says The President Now Tests Negative For Covid-19—But Not With A PCR Test White House doctor Sean Conley said in a memo released Monday that President Donald Trump has now tested negative for the coronavirus two straight day, as the president pushes ahead with planned campaign events 11 days after he was first diagnosed with Covid-19, but his statement did not say when the president was tested, and the type of test cited raises questions. In a statement Monday, Dr. Conley said Trump has “tested negative on consecutive days using Abbott’s BinexNOW antigen card.” Dr. Conley added that in combination with additional data on “viral load, subgenomic RNA and PCR cycle threshold measurements,” the tests indicate “a lack of detectable virus replication.” Dr. Conley did not release specific numbers about the PCR threshold nor did he say Trump tested negative with a PCR laboratory test, which is a more sensitive test generally seen as more reliable in determining whether someone is infectious. Dr. Conley’s use of the BinexNOW test appears to fall outside the scope of the FDA’s emergency use authorization of it, which states the test should be used “within the first seven days of symptom onset”; Trump developed symptoms 10 days ago.
Hour 2 – John Hewlett – Cardio Miracle
The discovery of the function of nitric oxide which won the Nobel Prize in medicine gave humanity hope to conquer the deadliest disease on the planet. Scientist would soon learn nitric oxide not only regulates blood pressure and increases blood flow, but plays a vital role on the whole body system. The goal to change lives one person at a time became Cardio Miracle’s clarion call. To do this the founder, John Hewlett, embarked on a five year journey to produce the world’s finest nitric oxide supplement. Cardio Miracle’s commitment to excellence resulted in the formulation of the most effective defense against heart disease and to provide the best natural pathway to produce nitric oxide in the body. Cardio Miracle was designed to give the body an instant jolt of nitric oxide and then sustain the nitric oxide boosting effects for a 12 hour period. The highest quality ingredients were selected before this formula was put through rigorous laboratory testing to ensure efficacy, quality and sustained delivery. The end result is the most synergistic blend of mostly organic, bioavailable active ingredients.
Struggling with Painful Neuropathy? Nitric Oxide Might Help One of the painful symptoms of diabetes is peripheral neuropathy. It’s the result of nerve damage and poor circulation. Nitric oxide may help support healthy circulation. Boosting nitric oxide, or NO, might help improve circulation, so your extremities get the oxygen and nutrients they need to function. Pain from neuropathy – common in people with diabetes – could be the result of damaged nerves. Poor circulation cuts off the supply of oxygen and nutrients that allow them to function properly. The improper nerve function may cause your body to perceive pain. Nitric oxide helps relax and dilate blood vessels so blood flows more easily, and oxygen and nutrients are delivered. Limited circulation can cause pain in other ways. It’s known to lead to swelling (edema) that puts pressure on nerves and swells capillaries that are required for oxygen supply. Think of what happens when you wrap an elastic tightly around your finger. It turns blue, swells, and eventually becomes painful enough for you to remove the elastic. NO counters this natural rubber band effect caused by poor circulation, helping to relieve swelling. Pain medications, including opioids which are highly addictive, are often prescribed to treat pain related to nerve damage. But these medications do nothing to address the cause of pain.
Ten or more medications, often prescribed to older heart failure patients, raises concerns More than half of older patients hospitalized for heart failure, a progressive condition in which the heart doesn’t pump blood as well as it should, are discharged from the hospital with prescriptions for 10 or more medications, according to new research published today in Circulation: Heart Failure, an American Heart Association journal. “High medication burden, also known as polypharmacy, is commonly associated with adverse events and reactions,” said Parag Goyal, M.D., M.Sc., senior study author and assistant professor of medicine at Weill Cornell Medicine and a geriatric cardiologist at NewYork-Presbyterian/Weill Cornell Medical Center in New York City. “As the treatment options for various conditions including heart failure expand and the population ages, it is becoming increasingly important to weigh the risks and possible benefits of multiple medications.” To explore the medication burden of older adults with heart failure, researchers examined the medical charts of 558 adults, aged 65 and older, covered by Medicare and hospitalized for heart failure between 2003 and 2014 at one of 380 hospitals in the U.S. All were participants in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study, a large nationwide prospective observational cohort of over 30,000 participants that began in 2003 and continues with ongoing follow-up.
Higher doses of vitamin D slowed progression of frailty in older mice, preclinical study shows When it comes to vitamin D, most adults exhibit either frank deficiency, which results in clear clinical symptoms, or insufficiency, which often goes undetected. But how that insufficiency impacts physical health and the vulnerability of older adults to frailty as they age has been difficult to determine. Now a University at Buffalo study of 24-28–month-old mice, the equivalent of 65-to-80-year-old adults, has found that frailty can be slowed with what might be considered “over” supplementation with vitamin D, referred to as “hypersufficiency.” Published Sept. 30 in Nutrients, the research builds on previous work that Kenneth L. Seldeen, Ph.D., first author and research assistant professor in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB, has been conducting for more than a decade with colleague Bruce R. Troen, MD, professor of medicine and chief of the Division of Geriatrics and Palliative Medicine and director of the Center for Successful Aging, both in the Jacobs School.
Study shows whole-fruit vitamin C boosts feelings of vitality A University of Otago study has shown adults low in dietary vitamin C can improve their feelings of vitality by eating two kiwifruit a day for two weeks. The study highlights the advantages of ingesting vitamin C through whole fruits such as kiwifruit. Observed effects were more marked than in a matched population taking vitamin C predominantly through a supplement tablet. Researchers from Otago’s Department of Psychology (Dunedin) and the Center for Free Radical Research in Christchurch ran a placebo-controlled intervention to test whether increasing vitamin C through whole fruit or tablets can improve feelings of vitality or zest for life. They recruited 167 participants between 18 to 35 years-old who had low baseline levels of vitamin C and randomly divided them into three groups; a kiwifruit group, an equivalent vitamin C tablet group (250 mg), or a placebo-tablet group. Each day for four weeks, participants were asked to eat two Sungold kiwifruit (a fruit known to be exceptionally high in vitamin C) or consume their tablet. Blood vitamin C levels and questionnaire measures of mood, fatigue, and well-being were measured fortnightly throughout the study.
Remember Friends, The Power to Heal is Yours!
More upcoming RSB events:
Trinity Health Freedom Virtual Expo – October 24-25