Podcasts about drug administration fda

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Best podcasts about drug administration fda

Latest podcast episodes about drug administration fda

The Todd Herman Show
Gates' and Fauci's people are deleting the records and hiding their crimes … it's their attempt at the Covid cover-up - Episode 37 - Hour 1

The Todd Herman Show

Play Episode Listen Later Jan 19, 2022 45:52


THE THESIS: The Party is erasing entire Covid patient databases, they are laundering “cases” and infections of injected people into the data of the “un-injected”, the FDA--a pharmagandist group--is aiding in the cover-up. But, God is watching.   THE SCRIPTURE:  Galatians 6: 7-10 7 Do not be deceived: God cannot be mocked. A man reaps what he sows. 8 Whoever sows to please their flesh, from the flesh will reap destruction; whoever sows to please the Spirit, from the Spirit will reap eternal life. 9 Let us not become weary in doing good, for at the proper time we will reap a harvest if we do not give up. 10 Therefore, as we have opportunity, let us do good to all people, especially to those who belong to the family of believers. THE NEWS: Vaccines Not Durable, Omicron Might Turn COVID-19 Endemic: Bill Gates US Government to end daily COVID death reporting. A document issued issued Jan 6 by the US Health and Human Services tells hospitals they are no longer required to report daily COVID-19 deaths to the federal government starting Feb 2. Story broken by @DataDrivenMD ← A SOCIALIST is calling this out?  Canada disappears an entire Covid database The dictator of the Province of Washington is--once again--lying about Covid “cases” in the people who have been injected and people who have not. - Michael Butcher THE MONOLOGUE: WHAT ELSE ARE THEY COVERING UP? [AUDIO] - Klaus Schwab opens World Economic Forum's virtual "Davos Agenda" and introduces China's Xi Jinping. [AUDIO] - Here's Klaus Schwab talking about gene-editing of human beings with Charlie Rose FOIA docs reveal Pfizer shot caused avalanche of miscarriages, stillborn babies When a group called Public Health and Medical Professionals for Transparency asked Pfizer to share the raw data from their COVID vaccine trials and post-marketing surveillance that was used to license the injection, the pharma giant linked up with the Food and Drug Administration (FDA) to refuse the Freedom of Information Act (FOIA) requests. In fact, the FDA (meant to serve and protect public health) hired Justice Department lawyers and went to court to shield the pharmaceutical giant from having to reveal its data – for 55 years. . . . Fortunately, a judge ruled that the FDA and Pfizer would have to answer their FOIA requests. Among the first reports handed over by Pfizer was a “Cumulative Analysis of Post-authorization Adverse Event Reports” describing events reported to Pfizer up until February 2021. It reveals that the drug behemoth received more than 150,000 serious adverse event reports within three months of rolling out its COVID shot, but here we will focus on Table 6 of the data on pregnant and lactating women who received the shots in the first few months of the rollout, which began December 11. Most of these women would have been healthcare workers because that was who the first rounds of shots went to. As the clinical trials preceding the rollout excluded pregnant women, these would have been the first pregnant and lactating women to have ever received the “vaccines.” Table 6 states that of 270 “unique pregnancies” that were exposed to the “vaccine”, “no outcome was provided for 238 pregnancies.” This leaves 32 pregnancies with known outcomes. Pfizer's report states that there were 23 spontaneous abortions (miscarriages), two premature births with neonatal death, two spontaneous abortions with intrauterine death, one spontaneous abortion with neonatal death, and one pregnancy with “normal outcome.” That means that of 32 pregnancies with known outcome, 28 resulted in fetal death. Children forced to Zoom into school ended up with suboptimal immune systems—the opposite of herd immunity. Young people with myocarditis  [AUDIO] - Robert Kennedy of explaining why pharma thugs wants this shoved into the arms of kids.  [AUDIO] -  Fauci speaking to Schawb about “disinformation.” Fabienne Schlumpf: Triple-Vaccinated Olympic Athlete Develops Myocarditis, Possible End Of Career A List of World Class Athletes Who Died Or Suffered Severe Injuries After COVID-19 Vaccine – PART 2 [AUDIO] - I do not agree Alex Berenson is controlled opposition, I love his work AND I think he carefully triangulates things and Dr. Robert Malone appeared to find out See omnystudio.com/listener for privacy information.

The Gary Null Show
The Gary Null Show - 01.12.22

The Gary Null Show

Play Episode Listen Later Jan 12, 2022 60:38


Research shows hemp compounds prevent coronavirus from entering human cells   Oregon State University, January 11, 2022 Hemp compounds identified by Oregon State University research via a chemical screening technique invented at OSU show the ability to prevent the virus that causes COVID-19 from entering human cells. Van Breemen and collaborators, including scientists at Oregon Health & Science University, found that a pair of cannabinoid acids bind to the SARS-CoV-2 spike protein, blocking a critical step in the process the virus uses to infect people. The compounds are cannabigerolic acid, or CBGA, and cannabidiolic acid, CBDA, and the spike protein is the same drug target used in COVID-19 vaccines and antibody therapy. A drug target is any molecule critical to the process a disease follows, meaning its disruption can thwart infection or disease progression.   Tomato concentrate could help reduce chronic intestinal inflammation associated with HIV   University of California Los Angeles, January 11, 2021 New UCLA-led research in mice suggests that adding a certain type of tomato concentrate to the diet can reduce the intestinal inflammation that is associated with HIV. Left untreated, intestinal inflammation can accelerate arterial disease, which in turn can lead to heart attack and stroke. The findings provide clues to how the altered intestinal tract affects disease-causing inflammation in people with chronic HIV infection, suggesting that targeting the inflamed intestinal wall may be a novel way to prevent the systemic inflammation that persists even when antiviral therapy is effective in controlling a person's HIV.     Too much sitting could mean worse outcomes for cancer survivors   Cancer Care Alberta (Canada), January 11, 2022 A new study shows those who sit too much and are not physically active are much more likely to die early from cancer or any other cause than those who are more active. Data on cancer survivors who took part in the U.S. National Health and Nutrition Examination Survey from 2007 to 2014 showed that inactive survivors who reported sitting more than eight hours a day were at the highest risk of dying. "Cancer survivors who did not meet the Physical Activity Guidelines for Americans [150 minutes per week of moderate-to-vigorous intensity leisure-time physical activity] and sit longer than eight hours per day had more than a fivefold increase in the risk of death from all causes—cancer and non-cancer," said lead researcher Lin Yang. The link was particularly troubling because the researchers found that as many as one-third of cancer survivors didn't exercise and sat more than six hours a day. Only about one-third got the recommended 150 hours of exercise a week, Yang said.     Running could improve brain function in people with Gulf War illness   Texas A&M University, January 10, 2022 It has now been three decades since 700,000 American troops responded to the invasion of Kuwait in the first Gulf War, and more than a third of those troops still suffer from the same condition: Gulf War Illness (GWI). Previously labeled Gulf War syndrome, GWI is characterized by persistent reduced cognitive function, memory problems, mood and sleep disturbances, chronic pain and fatigue. The exact cause of GWI is not known, though it is suggested that some combination of the prophylactic drug pyridostigmine bromide (PB), the mosquito repellant N, N-diethyl-m-toluamide (DEET), insecticide permethrin (PER), multiple pesticides, low doses of Sarin, and chronic war-related stress are to blame. Positive findings notwithstanding, the impracticalities of a drug that is not yet approved by the U.S. Food and Drug Administration (FDA) led Shetty to explore more accessible means. With perhaps the most simple of interventions that could be asked (certainly one familiar to our veterans), he found that running a few times each week could be powerful in the relief of GWI-related symptoms.     Why high-dose vitamin C kills cancer cells   Low levels of catalase enzyme make cancer cells vulnerable to high-dose vitamin C University of Iowa, January 9, 2022 Vitamin C has a patchy history as a cancer therapy, but researchers at the University of Iowa believe that is because it has often been used in a way that guarantees failure. Most vitamin C therapies involve taking the substance orally. However, the UI scientists have shown that giving vitamin C intravenously--and bypassing normal gut metabolism and excretion pathways--creates blood levels that are 100 - 500 times higher than levels seen with oral ingestion. It is this super-high concentration in the blood that is crucial to vitamin C's ability to attack cancer cells. Earlier work by UI redox biology expert Garry Buettner found that at these extremely high levels (in the millimolar range), vitamin C selectively kills cancer cells but not normal cells in the test tube and in mice. Physicians at UI Hospitals and Clinics are now testing the approach in clinical trials for pancreatic cancer and lung cancer that combine high-dose, intravenous vitamin C with standard chemotherapy or radiation. Earlier phase 1 trials indicated this treatment is safe and well-tolerated and hinted that the therapy improves patient outcomes. The current, larger trials aim to determine if the treatment improves survival. In a new study, published recently in the December issue of the journal Redox Biology, Buettner and his colleagues have homed in on the biological details of how high-dose vitamin C (also known as ascorbate) kills cancer cells.   People with early-onset Parkinson's disease may benefit from boosting niacin in diet   University of Leicester (UK), January 10, 2022 •    Team studied fruit flies with a mutation that mimics the human disease •    Niacin/Vitamin B3 is found in a variety of foods including meats and nuts •    Research suggests niacin boosts levels of NAD compound in body for energy generation and DNA repair, which is critical for keeping mitochondria in shape and Parkinson's at bay •    Drugs that block NAD-consuming DNA repair already exist to treat cancer - therefore these drugs could be repurposed to protect faulty mitochondria in Parkinson's disease "This study strengthens the therapeutic potential for Vitamin B3/niacin-based dietary interventions in the treatment of Parkinson's disease" - Dr Miguel Martins, MRC Toxicology Unit, University of Leicester People with certain forms of early-onset Parkinson's disease may benefit from boosting the amount of niacin in their diet, according to new research from the University of Leicester. Niacin, or Vitamin B3, is found in a variety of foods, including nuts and meat. The team from the MRC Toxicology Unit at the University of Leicester studied fruit flies with a mutation that mimics the human disease.     America's Crisis of Cultural Moral Panic   Richard Gale and Gary Null PhD Progressive Radio Network, January 12, 2022 It is one thing to show a man that he is in error and another to put him in touch with truth… No man's knowledge can go beyond his experience” – John Locke (Essays Concerning Human Understanding) Locke was not alone in questioning what we believe to be true knowledge, and pointing out the consequences of failing to discern falsehoods from reality. Locke was in excellent company.  Due to the scientific revolution, which inspired several generations of deep thinkers, naturalists and philosophers, including Rousseau, Kant, Spinoza, Darwin, Bacon and Voltaire, the Age of Enlightenment or the Age of Reason has dominated the intellectual world of ideas for nearly two centuries. Locke's statements remain pertinent because today there is a new generation that has been indoctrinated by the shortcomings of scientific materialism. It was intended to bring forth a new purity, an idyllic perfectionism of thought and beliefs founded alone upon objective inquiry. But now this higher ideal has degenerated into a juvenile revolution fuelling identity politics, the cancel culture of wokeness, and a passionate micro-aggression that derives hedonist pleasure in ridicule and insult. One of its more lofty goals is to end free speech as we know it – except for those who are woke. Other goals are to institute a faux collectivism and to abolish meritocracy or social rewards earned through effort and achievement. For many years, important voices of critical thought – Noam Chomsky, Henry Giroux, Jordan Peterson, to name a few, have been warning us that this day was rapidly approaching. However, since there are no dynamic leaders in the youth's woke moment of Maoist-style cleansing and purging of wrong-views, wrong attitudes and wrong beliefs, most of us in the older generations wrongly assume it would be a passing phase. But it wasn't. In fact, the consequences of this unleashed furor, evidenced by an absence of self-reflection and critical thought, has been channeled into a mob rule of dissent and abuse.  In the virtual world gatherings of protest across social media, it is nearly unstoppable. No one is challenging them, neither the mainstream media nor the majority of academia. Rather, corporate leaders and persuasive forces within the ranks of liberal democratic institutions are coming to their aid. Therefore, it proceeds under the cover of a silent political power to sustain its energy. On the other hand, today's youth have every reason to feel disenchanted and to suffer rampant existential angst, the emptiness of not feeling a deeper sense of purpose and meaning in the world at large.  American neoliberalism's and our educational system's single-minded attention on science and technology -- which in themselves are amoral disciplines -- and rote memorization and testing has resulted in two decades of our youth becoming increasingly illiterate in the humanities, critical evaluation and reflective inquiry.  It is also the most irreligious generation in American history. Without the skills of introspective thought to develop a sense of genuine well-being and true happiness, or what Plato called eudomonia as opposed to hedonia, (the pursuit of temporary or transient pleasures), our nation has tossed its youth to the rabid dogs of the social Darwinian rat race for survival. Therefore, it is not surprising that suicides among today's teens and twenty-somethings have risen 47 percentduring the past two decades.  Sadly the casualty rate is higher after we consider there are 36 percent more people living in their 20s today than there were at the turn of the century. Thirty-two percent of youth through their 20s have clinical anxiety disorders, 1 in 9 suffer from depression and almost 14 percent have ADHD.  Although the medical community would like us to believe these are either inherited or biological conditions attributable to brain chemical imbalances, there is absolutely no scientific consensus proving there is a direct, observable causal relationship between brain function and mental states.  Certainly there are correlated relationships; but correlation is not causation.  The latter is solely a belief, an assumption, without any conclusive and confirming data. The causes are elsewhere and perhaps to be found in our dysfunctional society and the complete breakdown of traditional ethical structures and universal values. In 1972, South African sociologist Stanley Cohen proposed the Moral Panic Theory, an irrational widespread fear that threatens one's sense of values, safety and cohesion to one's “tribal” identity.  This moral panic, Cohen observes, is bolstered by the injustices of the ruling elite and its mouthpieces in the media. It also centers aroundthose who society marginalizes and is based upon “ethnicity, class, sexuality, nationality and religion.” Ashley Grossman, writing for ThoughtCo, makes the point that those in power will ultimately most benefit from moral panics “since they lead to increased control of the population and the reinforcement of the authority of those in charge.” The panic aroused grassroots movements provides the government or state “to enact legislation and laws that would seem illegitimate without the perceived threat at the center of the moral panic.” The popular fear of the Covid-19 virus and the unvaccinated created by our federal health officials and their news media allies is another recent example of Moral Panic Theory. Unfortunately, most of the country has entered a Moral Panic phase: the vitriolic propaganda in both parties, the greed and opportunism of the oligarchic and corporate elite, QAnon and the Alt-Right, and the Woke-Left. Repeatedly woke students are demanding their schools and colleges make assurances that they are emotionally safe from ideas and philosophies that challenge their fragile comfort zones. Teachers and professors who challenge their students' illusions about knowledge and their fragile self-identity are being ostracized with calls for administrative dismissal. How many academicians are forced to remain silent to avoid the consequences of the new woke Inquisition? Such student actions are indicative of their weak sense of self-worth and existential angst; yet we must look at modern parental upbringing and our culture's leading elders, as noted by Jonathan Haidt, to diagnose the causal factors for this psychological catastrophe of two entire generations. Consequently, when collective panic reaches a threshold, Cohen's theory might explain the sudden eruption of irrational behavior entangled in the rise of a cancel culture built upon an intellectual anarchy that is frighteningly irrational. And it is equally endemic to the reactionary maleficence of white supremacists and militias. So when a new book emerges, White Fragility by Robin DiAngelo, and becomes the holy grail of woke truths, we are lectured that what will not be tolerated is any deviation or heresy its espoused twisted emerging social norm. The author's central theme is that if you have the misfortune of being born with the wrong genes into the wrong family a with the wrong skin color, you are a racist and will be such for the remainder of your days.  Hence every White person is condemned with a defective moniker blazed across the forehead. And since meritocracy likewise is damned, all achievements are reduced to an inherited privilege of having been born Caucasian.  Your attempt to defend yourself and profess your free speech is a testament of your heresy. No apology or act of humility can save you. It is a life sentence without parole for good behavior. White Fragility is already being taught in many schools, with the full cooperation of teacher unions and school administrators. Resistance will be a subversive act and an admission of your racism. It is critical to observe this may be heading towards a new paradigm of Orwellian social control. Yet there is barely a shred of credible scientific evidence to support DiAngelo's hypotheses.  It is a flawed opinion, and a dangerous one at that.  Worse, its long-reaching conclusions could advocate for a repressive regime of a future scientism dictatorship that Nobel laureate Bertrand Russell warned.  Russell noted that “collective passions” have a penchant to inflame “hatred and rivalry directed towards other groups.” He was acutely aware that “science is no substitute for virtue; the heart is as necessary for the good life as the head.” And DiAngelo's screed falls into the dark abysmal waters of genetic determinism that gave rise to racist fascism. Russell further cautioned that this distorted over-reliance on faux science could be “a curse to mankind.” Perhaps, during its Icarus moment, wokeness will self-destruct under its own rashness and the internal fire of its undiscerning ardor.  What carnage it leaves in its wake remains to be seen. Yet there is nothing new or original in the cultural rebellion we are witnessing. This game has been played out before in previous acts that strived for an adolescent and unreachable social perfection.  It will have its blowback.  In his Principia Mathematica, Isaac Newton observed that for every action there is an equally opposing reaction. However, we have yet to witness how it will boomerang. But we will.  In the meantime, a new class of wannabe priests is emerging within the woke movement, a priesthood David Hume warned about in his Essays, Moral, Political and Literary, which will in turn be an adversary to liberty. Consider the backlash after Harpers magazine published a Letter on Justice and Open Debate to warn about “a new set of moral attitudes and political commitments that tend to weaken our norms of open debate and toleration of differences in favor of ideological conformity.”  Signed by over 160 brilliant minds, academicians and authors – liberal and conservative -- including Noam Chomsky, Jonathan Haidt, Susannah Heschel, Steven Pinker, Gloria Steinem, etc, the letter gives a stark warning of the unwelcomed consequences of the new culture of censorship that the demonstration's leaders are ushering into the nation at large. The woke now demand retribution against its signers, in effect shutting down the nation's 200-plus years of free speech, the right to disagree and public discourse. Have those who are most rabidly eager to condemn and cancel the wide diversity of voices who disagree with their beliefs considered earlier precedents for their actions? It was the Spanish Inquisition.  In principle, how many today are in effect labeled heretics and “witches” because they have spoken publicly in favor of free speech and oppose censorship? May not the woke movement in turn become the harbinger of a new Inquisition, a new platform of economic and social persecution by the powerful and wealthy waiting in the corridors after the cult of woke loses its steam? The causal problems to our terrified culture is of course far deeper and has been identified and analyzed repeatedly in the writings of Chris Hedges and Henry Giroux.  Our nation thrives on victimizing others.  Now the once disenfranchised victims of the liberal woke generation, erupting from its simmering angst and meaninglessness, are determined to be the new victimizers. What is the end game when a populist uprising of disillusioned and psychologically traumatized youth at the mercy of capitalism's parasitical march to claim more victims gets the upper hand. The movement has now evolved beyond its original demands of racial justice for the Black and other minority communities who have been discriminated against by our institutions, particularly law enforcement and the private prison system. Now it is rapidly morphing into a massive autonomous cult of divisiveness and self-righteousness without a moral backbone that recognizes the essential values of forgiveness, reconciliation, and cooperative engagement for preserving a sane and productive culture that benefits all.     Insurance companies should ‘penalize' the unvaxxed, ethicist at New York University recommends   Professor Arthur Caplan said that people who have chosen not to get jabbed should pay higher insurance premiums and be barred from getting life insurance LifeSite News, Jan 6, 2022 An ethicist at New York University said that people who have not gotten jabbed should be punished by insurance companies. “By and large, if you're vaccinated and boosted, even if you get infected, you're going to be fine. You're going to be fine here. It's the unvaccinated who are going to be hurt, so why should anyone who is boosted bother at this point to do anything that makes the unvaccinated more safe?” CNN's John Berman asked Professor Arthur Caplan, the director of the medical ethics division at NYU Grossman School of Medicine. Professor Caplan agreed that the unvaccinated should be shamed and treated poorly by society, though he said he hopes he can change their minds. “I'll condemn them. I'll shame them. I'll blame them,” Professor Caplan said. “We can penalize them more, say you will have to pay more on your hospital bill. You can't get life insurance, disability insurance at affordable rates if you aren't vaccinated.”     NO DEATHS FROM VITAMINS - Safety Confirmed by America's Largest Database   Orthomolecular News Service, January 7th 2022 The 38th annual report from the American Association of Poison Control Centers shows zero deaths from vitamins. It is interesting that it is so quietly placed way back there where nary a news reporter is likely to see it. The AAPCC reports zero deaths from multiple vitamins. And, there were no deaths whatsoever from vitamin A, niacin, pyridoxine (B-6) any other B-vitamin. There were no deaths from vitamin C, vitamin D, vitamin E, or from any vitamin at all. On page 1477 there is an allegation of a single death attributed to an unspecified, unknown "Miscellaneous Vitamin." The obvious uncertainly of such a listing diminishes any claim of validity. There were no fatalities from amino acids, creatine, blue-green algae, glucosamine, or chondroitin. There were no deaths from any homeopathic remedy, Asian medicine, Hispanic medicine, or Ayurvedic medicine. None.   (NEXT)   40% of Israel could be infected with Covid-19 in current wave, says PM   France24, January 10, 2022 Israel could see up to nearly 40 percent of the population infected by coronavirus during the current wave, Prime Minister Naftali Bennett said Sunday, as testing facilities nationwide buckled Data presented at the cabinet meeting indicates that here, in Israel, between two to four million citizens in total will be infected during this current wave. A country of just 9.4 million, Israel has seen infections nearly quadruple over the past week compared to the previous one. The health ministry reported 17,518 new infections on Saturday. Health ministry data showed that more than 4.3 million Israelis were fully vaccinated with three shots, while 204 people are hospitalised in serious condition as a result of Covid-19 illness on Sunday. More than 1.5 million Covid cases, including 8,269 deaths, have been officially recorded in Israel.   (NEXT)   4th COVID Booster Shot Could Cause ‘Immune System Fatigue,' Scientists Say   As Israel moves ahead with fourth COVID shot, scientists told the New York Times the additional booster may cause more harm than good. Childrens Health Defense, January 7, 2022 COVID-19 booster shots could do more harm than good, according to scientists interviewed late last month by The New York Times. The scientists warned “that too many shots might actually harm the body's ability to fight COVID” and “might cause a sort of immune system fatigue.” On Monday, Israeli authorities began offering anyone over age 60 a chance to get a fourth shot, or second booster of the COVID vaccine. But scientists told The Times, before Israel confirmed it would offer the fourth shot, the science is not yet settled on using an additional booster shot to combat the new Omicron variant. There is one official report of an Israeli dying from Omicron. However, according to The Times of Israel, it is unclear that Omicron caused the death of the individual — a man in his 60s hospitalized weeks earlier from a pre-existing condition. A new report from the UK Health Security Agency showed booster doses are less effective against Omicron than previous variants, and their effectiveness wears off in only 10 weeks. Professor Hagai Levine, an epidemiologist and chairman of Israel's Association of Public Health Physicians, told The New York Times there's no published scientific evidence a fourth shot is needed to prevent severe illness from Omicron. “Before giving a fourth shot, it is preferable to wait for the science,” Levine said.   (NEXT)   145-Country Study Shows Increase Of Transmission And Death After Introduction Of Covid Vaccines   Truth Press, January 11, 2022 Instead of bringing an end to this pandemic as promised, the widespread rollout of the experimental vaccines has actually caused a sharp increase in Covid-19 cases and deaths across the world, according to a recently published preprint study that looked at data from the 145 of the most vaccinated countries in the world. The 99-page study titled “Worldwide Bayesian Causal Impact Analysis of Vaccine Administration on Deaths and Cases Associated with COVID-19: A BigData Analysis of 145 Countries” found that in the US specifically, the jab has caused a whopping 38% more Covid cases per million – and an even more astonishing 31% increase in deaths per million. In total, researchers found that almost 90% (89.84%) of the 145 countries experienced this negative effect from the vaccines after they were made available. From the study: “Results indicate that the treatment (vaccine administration) has a strong and statistically significant propensity to causally increase the values in either y1 [variable chosen for deaths per million] or y2 [variable chosen for cases per million] over and above what would have been expected with no treatment. y1 showed an increase/decrease ratio of (+115/-13), which means 89.84% of statistically significant countries showed an increase in total deaths per million associated with COVID-19 due directly to the causal impact of treatment initiation [vaccines]. y2 showed an increase/decrease ratio of (+105/-16) which means 86.78% of statistically significant countries showed an increase in total cases per millionof COVID-19 due directly to the causal impact of treatment initiation.” Perhaps the most telling part of the study's results is that the countries which recorded the fewest Covid deaths in 2020 were the ones to experience the largest increases in cases and deaths once the vaccine was introduced, with some of them seeing increases as high as over a thousand percent. In the study's conclusion, researchers warned that the substantial increase in deaths and cases should be “highly worrisome” for the policymakers around the world who have been promoting the experimental vaccines as the “key to gain back our freedoms.”   (NEXT)   Covid Vaccine-Injuries: "An Avalanche", says Attorney Aaron Siri   In November 2021, attorney Aaron Siri explained to an expert panel at Congress that his firm was seeing "an avalanche of submissions" from people seeking help to sue after covid vaccine-injuries.         Here we are in early January 2022, and:        ~ The CDC's data released December 31, 2021 contains 1,017,001 covid vaccine-injury records.        ~ The WHO's global database (VigiAccess) has collected 2,933,902 covid vaccine-injury records.        Even young children are being vaccine-injured.       From CDC's own publication, MMWR Dec. 31, 2021:        ~ "5,277 VAERS reports received for children aged 5–11 years" [1,028 (19.5%) were excluded from this analysis]        ~ "Approximately 5.1% of parents reported that their child was unable to perform normal daily activities on the day after receipt of dose 1, and 7.4% after receipt of dose 2. Approximately 1% of parents reported seeking medical care in the week after vaccination"       ~ "Two reports of death during the analytic period [November 3 - December 19, 2021]

Midday
Healthwatch with Dr. Leana Wen: Responding to the COVID-19 surge

Midday

Play Episode Listen Later Jan 3, 2022 49:47


Today, in our first show of the new year, it's the Midday HealthWatch.  Tom's guest is Dr. Leana Wen, who for years has been so generous sharing her time and expertise with Middaylisteners. Dr. Wen is an emergency physician and former Baltimore City Health Commissioner. She teaches at the George Washington University School of Public Health. She's also a columnist for the Washington Post, a medical analyst for CNN, a Senior Fellow at the Brookings Institution and the author of Lifelines: A Doctor's Journey in the Fight for Public Health. This morning, the US Food and Drug Administration (FDA) authorized booster shots of the Pfizer-BioNTech coronavirus vaccine for 12 to 15-year-olds, and it lowered the time frame for everyone getting a booster from six months to five months after the second dose of the Pfizer vaccine. The Centers for Disease Control and Prevention (CDC) will review the FDA panel's ruling. They're expected to make an official recommendation on Wednesday. Over the New Year's weekend, the US was reporting nearly 300,000 new cases of COVID-19 every day. That number has climbed to more than 400,000 daily cases as of today and it's likely much higher, given the number of people who are self-testing for the virus, and not reporting positive results. And it's not all due to the omicron variant. The Delta variant still accounts for more than 41 percent of cases in the United States, as of the week that ended on Christmas Day. The positivity rate in Maryland is nearly 27% and Maryland hospitals are under orders to limit various procedures so that scarce medical personnel can concentrate on patients with severe COVID-related disease. Maryland reported more than 14,000 new cases in the last 24 hours. More than 2,700 people are currently in Maryland hospitals; that's nearly 200 more than on Sunday. As we mentioned, children over the age of 12 will soon be eligible to get a booster. But, first things first: nationally, only 32% of kids above the age of 5 have received their first shot. And, a year into vaccine availability, only about 62% of Americans are fully vaccinated, well behind dozens of other countries. Dr. Leana Wen joins us on Skype for the hour to discuss these and other COVID-related developments... And as always, we welcome your questions and comments. See omnystudio.com/listener for privacy information.

#GoRight with Peter Boykin
THE FDA AUTHORIZED A PILL TO TREAT COVID

#GoRight with Peter Boykin

Play Episode Listen Later Jan 3, 2022 7:33


Pfizer is buying a biopharmaceutical company that works on cardiovascular and inflammatory medicines... It's a curious purchase, considering that one of the most prevalent side-effects of Pfizer's covid vaccine is heart inflammation. Sounds like Pfizer is double-dipping on profits: Make money off the vaccine that causes heart inflammation. Then make more money off treatments for the inflammation you caused.Gross.https://thenationalpulse.com/2021/12/20/pfizer-is-buying-a-cardiovascular-biopharma-company-for-6-7bnTHE FDA AUTHORIZED A PILL TO TREAT COVID. HERE'S WHAT WE KNOW ABOUT ITThe Food and Drug Administration (FDA) just approved the first pill to treat newly infected Covid patients, and it can be taken from the comfort of your own home. The pill has been proven to fight off the worst effects of the virus. The pill is called Paxlovid and is created by Pfizer. The FDA authorization allows doctors to prescribe Paxlovid for high-risk patients, ages 12 and over. Clinical trials show it's most effective if taken in the first five days that symptoms arise.It's only going to high-risk patients right now because there is a limited supply: roughly 60,000 courses available in the U.S. But they anticipate having 250,000 available by the end of January.The major benefit to taking this pill as opposed to some of the other therapeutic treatments that are currently available is that you don't need to be in a clinical setting to take it and it doesn't require an IV or injection. Paxlovid is just three pills taken twice a day for five days at home.Clinical trials found that the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate Covid within three days of symptoms arising. It also found:Less than 1% of patients were hospitalized and none died at the end of the 30-day trialCompared to 6.5% of placebo group patients who were hospitalized, which included 9 deathsThis isn't a new concoction: This new pill is part of a family of antiviral drugs that have been around for decades known as protease inhibitors which block a key enzyme that viruses need to multiply in the body. This type of anti-viral has been used to treat HIV and hepatitis C in the past.Therapeutics > Vaccines: I have always favored the development of effective therapeutic over mass vaccination. President Trump felt the same way. After he beat Covid in October of 2020, he said: “We have to get [theraputics] approved, and I want to get ‘em to the hospitals where people are feeling badly. That's much more important to me than the vaccine.”So this pill seems like a step in the right direction.The flip side: With all of that said, Pfizer charges the U.S. government $500 per treatment. So the Pfizer medical machine is making money hand over fist between this and their mRNA jabs. So there are definitely questions to be raised over why this treatment is accepted, but cheap, widely available drugs like Ivermectin and Hydroxy aren't. But that's a whole other topic for another day...[Source: Associated Press]https://www.spreaker.com/user/9922149/the-fda-authorized-a-pill-to-treat-covid

Voices In Validation
Integrate Risk into Change Control

Voices In Validation

Play Episode Listen Later Dec 28, 2021 53:10


This week, Alan Golden hosts a comprehensive discussion on the changes driven by risk and conversely risk updates that are driven by change as well as risk integration. Alan will share his expertise from over 30 years in the medical device industry. Alan Golden: Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management, and process/test method validation. Alan has more than 30 years of experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.    This episode is brought to you by IVT Network's Validation Week.

Ben Fordham: Highlights
How eyedrops hitting US shelves could do away with reading glasses

Ben Fordham: Highlights

Play Episode Listen Later Dec 28, 2021 1:25


An eye drop which could mean millions of people don't need to wear glasses has been approved by the US Food and Drug Administration (FDA). See omnystudio.com/listener for privacy information.

Alan Jones Daily Comments
How eyedrops hitting US shelves could do away with reading glasses

Alan Jones Daily Comments

Play Episode Listen Later Dec 28, 2021 1:25


An eye drop which could mean millions of people don't need to wear glasses has been approved by the US Food and Drug Administration (FDA). See omnystudio.com/listener for privacy information.

3AW Breakfast with Ross and John
World first eye drop could allow millions to ditch reading glasses

3AW Breakfast with Ross and John

Play Episode Listen Later Dec 27, 2021 5:44


An eye drop which could mean millions of people don't need to wear glasses has been approved by the US Food and Drug Administration (FDA). See omnystudio.com/listener for privacy information.

CIOs and Bow Ties
DEA Emboldens Delta-8 Hemp Businesses By Signaling That The Cannabinoid Is Federally Legal

CIOs and Bow Ties

Play Episode Listen Later Dec 27, 2021 8:08


Our website - https://www.gregsilberman.com/private-client-group/https://www.youtube.com/watch?v=sYzUgyvbr5w (come learn with me)points form the article:- DEA Emboldens Delta-8 Hemp Businesses By Signaling That The Cannabinoid Is Federally Legal- Officials with the federal agency have indicated to state regulators that only products containing more than 0.3 percent delta-9 THC—the most commonly known intoxicating cannabinoid—is controlled, but the 2018 Farm Bill that legalized hemp does not explicitly ban THC isomers.-Food and Drug Administration (FDA), the latter of which recently issued warnings about possible adverse health effects from delta-8 products.- what I want to say, and I'll be very, very deliberate and clear, at this time I repeat again, at this time per the Farm Bill, the only thing that is a controlled substance is delta-9 THC greater than 0.3 percent on a dry-weight basis.This communication is available for information purposes only and does not constitute an offer or sale or any form of general solicitation or general advertising of interests in any fund or investment vehicle. Any such offer will only be made in compliance with applicable state and federal securities laws pursuant to an offering memorandum and related offering documents which will be provided to qualified prospective investors upon request.  Prospective investors should review a Fund's offering memorandum carefully, which includes important disclosures and risk factors associated with an investment in a Fund. The views and strategies described may not be suitable for all investors. They also do not include all fees or expenses that may be incurred by investing in specific products. Past performance is no guarantee of future results. Investments will fluctuate and when redeemed may be worth more or less than when originally invested. You cannot invest directly in an index. The opinions expressed are subject to change as subsequent conditions vary. Reliance upon information in this material is at the sole discretion of the reader. Advisory services offered through ACG Wealth Inc. ACG Wealth Inc. is an affiliate of ACG Investment.

RW notícias - fique sempre bem informado
Remédio contra a Covid-19 tem uso emergencial liberado nos EUA

RW notícias - fique sempre bem informado

Play Episode Listen Later Dec 22, 2021 2:36


A Food and Drug Administration (FDA), agência reguladora norte-americana, autorizou o uso emergencial do tratamento oral da Pfizer contra Covid-19. A recomendação de administração do Paxlovid é para pacientes adultos e pediátricos (maiores de 12 anos com ao menos 40kg) com covid que tenham alto risco de desenvolver quadros graves da doença.

The Gary Null Show
The Gary Null Show - 12.17.21

The Gary Null Show

Play Episode Listen Later Dec 17, 2021 61:24


More evidence for vitamin D in MS prevention   University of California San Francisco and Australian National University, December 13 2021. Neurology reported findings of an association between greater time spent outdoors and a reduction in the risk of developing early onset multiple sclerosis (MS) among children and young adults. “Sun exposure is known to boost vitamin D levels,” explained study co-senior author Emmanuelle Waubant, MD, PhD, who is a professor at the UCSF Department of Neurology. “It also stimulates immune cells in the skin that have a protective role in diseases such as MS. Vitamin D may also change the biological function of the immune cells and, as such, play a role in protecting against autoimmune diseases.” Nineteen percent of participants with MS reported spending less than 30 minutes per day outdoors during the summer before the study, compared to only 6% of those without the disease. In comparison with spending less than 30 minutes outdoors during the previous summer, 30 minutes to an hour per day spent outdoors was associated with an adjusted 52% lower chance of acquiring MS and spending 1 to 2 hours daily was associated with an 81% lower risk. High ambient ultraviolet radiation exposure during summer was also protective against the disease.   (NEXT)   Social stress messes up the hippocampus Polish Academy of Sciences, December 3, 2021 Stress might endanger your hippocampus according to a research paper recently published in PLOS One by Stankiewicz and colleagues. Social stress modifies the hippocampal transcriptome Stress responses have been correlated with altered inflammatory functions; for example, infiltration of leukocytes in the brain of socially defeated mice has been reported. The fact that both the hippocampus and the prefrontal cortex stress mice led the researchers to believe that chronic stress may impact the whole brain.   (NEXT)   Popular antioxidant linked to pain relief   University of Naples Federico II (Italy), December 12, 2021 People with pain of unknown causes who took alpha-lipoic acid (ALA) experienced less pain than a placebo group, a double-blind study in the December 2021 issue of Biomedicine & Pharmacotherapy revealed.1 According to the study authors, these findings suggest that this three-decades-old ingredient might be a viable option for patients with unknown causes of joint, muscle or nerve pain. “The use of ALA…represents an interesting option, especially in primary pain with unknown etiology where no specifically-targeted drug can be selected, and where symptomatic drugs may not always be effective but may be associated with serious adverse effects under prolonged treatment,” wrote Cristina Esposito of University of Naples Federico II and associates.   (next)   Why an avocado may be the key to a healthy life (and a slim waist)   University of Wollongong (Australia), December 13, 2021 University of Wollongong's (UOW) Associate Professor Yasmine Probst has been researching the link between diet and health outcomes for years. In one of her recent scientific papers, published in the prestigious British Journal of Nutrition, she finds a correlation between avocado consumption and lower body weight and a smaller waist circumference. "Firstly, we were able to show that both lower body weight and a lower waist circumference have been positively associated with increased avocado intake. Then, we noticed that greater consumption of avocados was also associated with significantly lower consumption of discretionary (junk) foods," Professor Probst explained.   (NEXT)   Study reveals environment, behavior contribute to some 80 percent of cancers   Stony Brook University December 16, 2021 A team of researchers from Stony Brook University have found quantitative evidence proving that extrinsic risk factors, such as environmental exposures and behaviors weigh heavily on the development of a vast majority (approximately 70 to 90 percent) of cancers. The finding, reported in  Nature, in a paper titled "Substantial contribution of extrinsic risk factors to cancer development," may be important for strategizing cancer prevention, research and public health. IThe interdisciplinary team of researchers from the Departments of Applied Mathematics and Statistics, Medicine, Pathology and Biochemistry, concluded the opposite – that most cancers are the result of external risk factors.   (NEXT)   Melatonin exacerbates asthma   Tohoku University (Japan), December 10, 2021 Asthma sufferers generally find their condition gets worse at night. Now, a research group may understand why. Melatonin, a sleep hormone that is sometimes prescribed to treat insomnia, exasperates the constriction of the bronchus—the pathway that moves air to and from the lungs. Patients with asthma often experience a worsening of asthmatic symptoms at night in so-called "nocturnal asthma." According to reports, more than 50 percent of asthma deaths occur at night, exposing a link between nocturnal asthma symptoms and asthma deaths. Although some have proposed several triggers that explain the pathogenesis of nocturnal asthma, the precise mechanisms regulating this asthma phenotype remain obscure.   (OTHER NEWS NEXT)   2021 Arctic Report Card reveals a (human) story of cascading disruptions, extreme events and global connections   THE CONVERSATION. December 14, 2021 On Dec. 14, 2021, a team of 111 scientists from 12 countries released the 16th annual Arctic Report Card, a yearly update on the state of the Arctic system. Like an annual checkup with a physician, the report assesses the Arctic's vital signs – including surface air temperatures, sea surface temperatures, sea ice, snow cover, the Greenland ice sheet, greening of the tundra, and photosynthesis rates by ocean algae – while inquiring into other indicators of health and emerging factors that shed light on the trajectory of Arctic changes. As the report describes, rapid and pronounced human-caused warming continues to drive most of the changes, and ultimately is paving the way for disruptions that affect ecosystems and communities far and wide. The sea ice is also thinning at an alarming rate as the Arctic's oldest and thickest multi-year ice disappears. This loss of sea ice diminishes the Arctic's ability to cool the global climate. It can also alter lower latitude weather systems to an extent that makes previously rare and impactful weather events, like droughts, heat waves and extreme winter storms, more likely. The eight major Arctic rivers are discharging more freshwater into the Arctic Ocean, reflecting an Arctic-wide increase in water coming from land as a result of precipitation, permafrost thaw and ice melt. Remarkably, the summit of the Greenland ice sheet – over 10,000 feet above sea level – experienced its first-ever observed rainfall during summer 2021. This year's report highlights how retreating glaciers and deteriorating permafrost are also posing growing threats to human life through abrupt and localized flooding and landslides. It urges coordinated international efforts to identify these hazards. More rain in the Arctic will further multiply these threats. The Arctic Report Card compiles observations from across the circumpolar North, analyzing them within a polar projection of our planet. This puts the Arctic at the center, with all meridians extending outward to the rest of the world. In this view, the Arctic is tethered to societies worldwide through a myriad of exchanges – the natural circulation of air, ocean and contaminants, the migration of animals and invasive species, as well as human-driven transport of people, pollution, goods and natural resources. The warming of the Arctic is also allowing for greater marine access as sea ice loss permits ships to move deeper into Arctic waters and for longer periods of time.   (NEXT)   Congress cashes in: Report finds dozens of DC lawmakers held shares in vaccine companies LIFESITE NEWS, Dec 15, 2021 A Business Insider analysis has shown that at least 75 federal legislators held stock in Moderna, Johnson & Johnson, or Pfizer in 2020. Meanwhile, the paper trail shows Big Pharma corporations shelled out millions of dollars to finance electoral campaigns and lobby the federal government. The data raised serious ethical concerns about the objectivity of the legislature, prompting questions about how much government actors stand to profit from coercive jab mandates which have deprived Americans of their rights and kneecapped a struggling economy. According to the December 13 report, an analysis of federal financial records led Business Insider to conclude that “[d]ozens of Republican and Democratic lawmakers on Capitol Hill have invested in companies that have a direct stake in the nation's response to the COVID-19 pandemic.” In its analysis — part of the Conflicted Congress project — the news outlet reviewed some “9,000 financial-disclosure reports for every sitting lawmaker and their top-ranking staffers.” The report found that last year at least 35 U.S. representatives and 13 senators held shares in Johnson & Johnson, which has produced the only single-shot COVID injection on the market. Meanwhile, 34 representatives and 11 senators held shares in Pfizer, the Big Pharma giant whose double-dose mRNA jab has been approved under an “emergency use authorization” by the Food and Drug Administration (FDA) for children as young as five years old. Moderna's shareholders are fewer, with just two representatives and their spouses holding shares in the Bill Gates-funded corporation. “Lawmakers held these investments in COVID-19-minded companies as Congress was at the center of pandemic relief efforts,” Business Insider reported. “In 2020 and 2021, members of Congress voted on six relief bills together worth nearly $6 trillion. Congress also authorized more than $10 billion to help drug companies develop and distribute vaccines and forced health insurers to cover the cost of getting the shot.” Non-profit organization OpenSecrets, which follows the financial dealings of politicians, reported that through PACs and individuals Pfizer spent over $4 million in 2020 to bankroll candidates and committees. Employees and PACs working for Johnson & Johnson, meanwhile, spent over $2 million. “Both Pfizer and Johnson & Johnson gave more to Democrats than to Republicans,” Business Insider reported, adding that “[o]f the big three vaccine manufacturers, Pfizer leads with the most money spent lobbying members of Congress during the pandemic.” Pfizer spent nearly $11 million to lobby the federal government in 2020, OpenSecrets found, while Johnson & Johnson spent $7.9 million on lobbying last year. Business Insider added that the relative newcomer Moderna, which began to lobby the federal government back in 2019, spent $280,000 on lobbying in 2020 and $420,000 in 2021.   (NEXT)   Taiwan: 79% of Covid Cases Are People Who Are “Vaccinated”   DAILY EXPOSE, DECEMBER 13, 2021 • For the three weeks 19 November to 10 December 2021, 170 (79%) of the 215 people who tested positive for Covid had previously had at least one dose of a Covid injection. The summary of the positive tests or Covid “cases”, by vaccination status, shown by the CDC's daily reports for the period 19 November to 10 December (E&OE).  Excepting two days, 26-27 November, all days show that more than 60% of positive test were those who had been “vaccinated” against disease. Prof. Sucharit Bhakdi has said: the Covid vaccines were designed to fail.  Antibodies produced in the blood stream, such as those produced after an injection into a muscle, cannot protect anyone from a respiratory infection.  If a person is infected with a respiratory virus after being injected it is not a “breakthrough” infection as the “vaccination” did not protect against respiratory viral infection in the first place. Dr., Richard Fleming has concluded the same.  Using Pfizer, Moderna and Johnson & Johnson's trial data used to calculate efficacy of their Covid injections, Dr. Fleming demonstrated that with an absolute risk ration of 0.88%, less than 1%, “there is no statistical reduction in Covid cases between the vaccinated and the unvaccinated.”   (NEXT)   Digital Surveillance — the Real Motive Behind Push to Vaccinate Kids   “The real purpose behind the historic, unprecedented push to vaccinate the very young, even against diseases like COVID that do not pose a threat to them, is to fold the current generation of children into the blossoming global digital identity system.” By Michael Nevradakis, Ph.D., Childrens Health Defense. December 15, 2021 It was the beginning of the preceding decade, January 2010, when Bill Gates, via the Bill & Melinda Gates Foundation, proclaimed “[w]e must make this the decade of vaccines,” adding that “innovation will make it possible to save more children than ever before.” In launching this so-called “Decade of Vaccines,” the Gates Foundation pledged $10 billion in funding. But Gates wasn't the only actor behind this initiative. Moreover, in 2010, a “Global Vaccine Action Plan” was announced as part of this initiative. It was a collaboration with the World Health Organization (WHO), UNICEF and the National Institute of Allergy and Infectious Diseases (NIAID), with Dr. Anthony Fauci serving on the leadership council. As the Gates Foundation stated at the time: “The Global Vaccine Action Plan will enable greater coordination across all stakeholder groups — national governments, multilateral organizations, civil society, the private sector and philanthropic organizations — and will identify critical policy, resource and other gaps that must be addressed to realize the life-saving potential of vaccines.” What, or who, is the GAVI Alliance? Also known as the “Vaccine Alliance,” it proclaims a mission to “save lives and protect people's health,” and states it “helps vaccinate almost half the world's children against deadly and debilitating infectious diseases.” GAVI goes on to describe its core partnership with various international organizations, including names that are by now familiar: the WHO, UNICEF, the Bill & Melinda Gates Foundation and the World Bank. (Far from helping the world's poor, the World Bank has been described by a former insider, John Perkins, as an organization that uses “economic hit men” to subjugate financially crippled countries). In 2018, GAVI, through its INFUSE (innovation for update, scale and equity in immunization) Initiative, put forth the following “food for thought”: “Imagine a future in which all children have access to life-saving vaccines no matter where they live — a future in which parents and health workers ensure their timely vaccination, a future in which they have their own digitally stored health record that cannot be lost or stolen, a future in which, regardless of gender, economic or social standing, this record allows each child (and parents) to have access to a bank account, go to school, access services and ultimately build a prosperous life. “This future is possible today. With the latest advances in digital technologies that enable more effective ways to register, identify births and issue proof of identity and authentication for access to services — we are on the brink of building a healthier and more prosperous future for the world's most vulnerable children.” The GAVI Alliance also closely collaborates with the ID2020 Alliance, founded in 2016, which claims to advocate in favor of “ethical, privacy-protecting approaches to digital ID,” adding that “doing digital ID right means protecting civil liberties. Unsurprisingly, there is no clarification provided regarding the potential loss of civil liberties for individuals who choose, for any reason, not to be vaccinated and who are therefore excluded from large swaths of society in areas where COVID passports have been implemented and enforced. Such rhetoric on the part of ID2020 is reminiscent of the public statements put forth by the European Union (EU) as it was preparing to launch its so-called “Green Pass” earlier this year. Highlighting the possibilities that the GAVI-ID2020 collaboration could bring, the INFUSE call for innovation states: “According to the ID2020 Alliance — a public-private partnership that includes Gavi — the use of digital health cards for children could directly improve coverage rates by ensuring a verifiable, accurate record and by prompting parents to bring their children in for a subsequent dose. “From the parents' perspective, digital records can make it convenient to track a child's vaccines and eliminate unnecessary paperwork. “And as children grow, their digital health card can be used to access secondary services, such as primary school, or ease the process of obtaining alternative credentials. Effectively, the digital health card could, depending on country needs and readiness, potentially become the first step in establishing a legal, broadly recognized identity.” The final report from these sessions indicates, among other things, a desire from the stakeholders for the expansion of public-private partnerships for the further development and implementation of digital ID regimes worldwide, including in the Global South. One of the stakeholders present, the not-for-profit Secure Identity Alliance, touts its support for “the provision of legal, trusted identity for all and driving the development of inclusive digital services necessary for sustainable, worldwide economic growth and prosperity.” A paper published in July by the Security Identity Alliance discusses “making health certificates a workable reality.” One of the five principles the paper puts forth for such health passports is that they are “futureproofed,” by offering “multi-purpose functionality” in order to “ensure ongoing value beyond today's current crisis.” Moreover, one of its founding members and current board members is the Thales Group, a private company involved in aerospace, defense and security — in short, a defense contractor. On its website, the Thales Group proudly promotes its “smart health card” and Digital ID Wallettechnology. Amidst utopian language claiming “we're ready for change” and “putting citizens in control,” the Digital ID Wallet promises the public the ability to “access the rights and services to which we are entitled.” The U.S. House of Representatives on Nov. 30 passed H.R. 550, the Immunization Infrastructure Modernization Act of 2021. If passed by Congress, this law would provide $400 million in funding to expand vaccine-tracking systems at the state and local level, enabling state health officials to monitor the vaccination status of American citizens and to provide this information to the federal government. Vaccine passports and no-fly lists for the unvaccinated — a concept for which Fauci expressed his support — could be created under the law. In September, for instance, Apple announced a partnership with eight states — Arizona, Connecticut, Georgia, Iowa, Kentucky, Maryland, Oklahoma and Utah — to make those respective states' driver's licenses available in digital form via the Apple Wallet platform. Indeed, New York went so far as to make a “blueprint” of its vaccine pass platform available, “as a guide to assist other states, territories, and entities in the expansion of compatible COVID-19 vaccine credential systems to advance economic development efforts nationwide.” Looking at the EU, one of the bloc's priorities as part of its 2019-2024 five-year plan is to create a “digital identity for all Europeans.” Namely, each EU citizen and resident would have access to a “personal digital wallet” under this initiative. The EU subsequently presented its plans for the “European Digital Decade,” where under the EU's “Digital Compass,” 100% of key public services will be available digitally, with a target of 80% uptake of digital identification documents. A recent article in The Atlantic, “Why Aren't We Even Talking About Easing COVID Restrictions?” questioned why vaccine passport mandates in the U.S. have no sunset date. Indeed, if the proclamation of the Secure Identity Alliance regarding the need to “futureproof” such digital documents is any indication, it may be the case that governments have no intention to scrap vaccine passports.   (NEXT)   AmazonSmile donated more than $40,000 to anti-vaccine groups in 2020   THE GUARDIAN. 15 Dec 2021 Amazon's charitable program is paying tens of thousands of dollars to anti-vaccine groups in a move experts say is “shocking” as millions of Americans remain unvaccinated in the face of another Covid-19 wave. AmazonSmile reportedly donated more than $40,000 to leading sources of vaccine misinformation in 2020, according to separate analyses by Popular Information and the Washington Post. The charity program of the e-commerce giant donates 0.5% from purchases to designated nonprofits – including at least a dozen organizations working against widespread vaccination in the US. The National Vaccine Information Center has received $41,533.71 over the course of several years, according to an anonymous volunteer. Last year, Amazon gave them $12,675, the Post reports – one of a dozen groups to receive such funding. Children's Health Defense, headed by Robert F Kennedy Jr, received $10,969; Physicians for Informed Consent received $3,626; and Informed Consent Action Network received $2,970.41.   (NEXT)   Latest VAERS estimate: 388,000 Americans killed by the COVID vaccines   Steve Kirsch, December 14, 2021 I have argued that the anaphylaxis rate is an appropriate number to use to (under) estimate deaths because I believed that deaths would be less reported than anaphylaxis to VAERS for two reasons: 1) usually lacks the time proximity to vaccination, 2) the person seeing the death may not know the vaccination status of the victim and may not technically be required to report the death. That day has arrived courtesy of Wayne at VAERS Analysis. Wayne did a URF computation using death data in CMS. This overcomes any objections about the validity of using anaphylaxis rates as a proxy for death rates. The VAERS URF he computed was 44.64. This seems reasonable to me. It's really not far from the 41 I calculated. Also, Wayne subsequently looked at the numbers for 9 states. The average value was 40, not far from the 41 I calculated from anaphylaxis. I had one of my team members double check his numbers. No mistake. Now, let's see what that means. As of Dec 14, 2021, there are 9,136 deaths reported into VAERS. If we subtract out more than twice the total number of deaths reported in any previous year (to be super conservative about estimating background deaths): So our new best estimate of the number of “excess deaths” caused by the vaccine is 388,000. Because there isn't a plausible mechanism of excess death other than the vaccine (certainly our “always vigilant” CDC has never suggested an alternate cause), the process of elimination leads us to conclude the obvious: that these excess deaths were, in fact, caused by the vaccine. This should really be a surprise to anyone paying attention to the clinical trials. For example, in the Pfizer trial, you were much more likely to die if you got the vaccine than if you got the placebo. They simply forgot to mention that in the abstract of the paper (and they were incapable of accurately counting the number of deaths in each group as well). In short, the vaccine is a killing machine.  

ASCO Daily News
Confronting Challenges in Oncology in 2022 With Dr. Derek Raghavan

ASCO Daily News

Play Episode Listen Later Dec 16, 2021 26:40


Guest host, Dr. John Sweetenham, associate director for Clinical Affairs at the UT Southwestern Harold C. Simmons Comprehensive Cancer Center, and Dr. Derek Raghavan, President of the Levine Cancer Center at Atrium Health in North Carolina, discuss some of the major issues ahead for the oncology community in 2022, including tension caused by the COVID-19 pandemic, achieving true equity of care, how to use molecular testing in an optimized fashion, and the future of the oncology workforce. Transcript  Dr. John Sweetenham: Hello, and welcome to ASCO Daily News podcast. I'm John Sweetenham, the associate director for Clinical Affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center and guest host of the podcast. Today, we'll be discussing the challenges ahead for the oncology community in 2022 with Dr. Derek Raghavan, President of the Levine Cancer Institute at Atrium Health in North Carolina. Our full disclosures are available in the show notes, and disclosures relating to all episodes of the podcast can be found on our transcripts at asco.org/podcasts. Derek, always a pleasure to have you here, and great to have you back on the podcast again.   Dr. Derek Raghavan: Hey, John. Always enjoy chatting together.   Dr. John Sweetenham: Derek, we're interested today to get your insights into what you think are going to be the major challenges facing the oncology community in 2022. I think each of us could come up with a pretty substantial list, but very interested to hear what you think are going to be those issues which are going to be uppermost in our mind as we move into the new year.   Dr. Derek Raghavan: Well, I think there are a number of important issues, John. I think everybody in clinical practice, medical or nursing, or whatever, have been brutalized somewhat by the COVID-19 pandemic, and I think everyone's tired and a bit cranky, and they're upset with a schism between the fringe and the science-based clinicians. So, I think that underscores everything. And there's an anxiety and a tension that I think is just new.   From the practical standpoint, which is where I think your question is directed, yeah, I think there will be issues that relate to achieving true equity of care. And I think hopefully, the focus will move from analysis paralysis to actually doing things and measuring outcomes. I think there will be the tension between value, price, and cost. People are spending an awful lot of money on health care. That's going to be an issue.   We have very good information on molecular prognostication, but a lot of the data that are coming out are from technologies that are not fully validated and not even standardized. There's a lot of disinformation and misinformation coming out, and I think we're going to have to address that. I think those are 3 themes that could keep us talking for quite a while.   I think the other thing, which is more up your alley than mine, is we've been watching CAR T[-cell therapy] emerge. I think we've got a beginnings of a pretty good handle on how CAR T[-cell] relates to hematological malignancy. It's much less clear in the solid tumors, and there is a bit of a tendency to do what used to happen in the 1970s and '80s, which is here's a new treatment. Let's give it a whack and see what happens.   But this is very expensive. We don't want to fall into the trap of how bone marrow transplant was introduced as a standard of breast care management for nearly a decade, based on somewhat flimsy evidence. So, we need to be a little more thoughtful about how we introduce CAR T[-cells] into the solid tumors.   Dr. John Sweetenham: Thanks. Yeah, plenty to discuss there, as you say. And what I'd like to do just because it is such a topical issue and continues to be at the moment is just pick up a little on the COVID-19 theme. I think that we've all seen a great deal of discussion in recent months about many of the consequences of COVID-19, including delayed screenings, late diagnosis, clinician burnout, and so on. But I'm interested in your insights on a couple of things.   Number 1, since we're now seeing the emergence of further new variants, what do you think that this is going to mean for the oncology community in terms of handling these new variants within the context of our patients with cancer? And then secondly, because I'm intrigued by one of the things you mentioned in our discussions about this podcast, you mentioned the changed relationship between health professionals and parts of the community as a consequence of COVID-19. And interested to hear you expand just a little bit on that. So, kind of 2 questions wrapped up in 1 there.   Dr. Derek Raghavan: Yeah. Well, I think the 2 are connected. The old style of physicians has always liked to be sure of their ground and to have a firm database when they talk about things. Particularly with the new variants, while it's completely appropriate to be transparent about the fact that they knew that they seemed different and so on, I think there is the problem that there are a lot of physicians who are now becoming TV personalities as much as physicians and who are talking all the time.   I'm not critical of that, but the problem is that they're being honest in saying we don't really know this, but this is what I think, and then they have to change direction. So, what's happening is, for the first time in a long time, physicians are regularly being quoted and being seen as saying things that are not necessarily correct, and that reduces confidence by the community and the physicians. At the same time, COVID-19, in my view, highly, inappropriately became a political football.   You have people who have absolutely no training, so radio hosts, football quarterbacks, basketball stars making extraordinary statements about COVID-19 and their approach to vaccination, masking, and other things where they have absolutely no business doing it. But they are people who are believed. They're high profile. And so, there's now a schism emerging between patients who listen to people who have no medical training at all and no basis for what they say and those particularly in the political domain who have politicized this and created a situation where, once upon a time, a physician was at least seen as coming from the right place and with good intent.   But we've both seen so many of these public demonstrations where physicians and public health physicians are being castigated for simply espousing good practice. Now, with respect to managing the variants, I think the fact is we have some basic principles that I have believed now for 2 years. Masks reduce the chance of getting any type of COVID-19. They just do. If you wear a mask most of the time when you're out and about, you're going to cut your chances down. Vaccination reduces the chance of ending up in the ICU unless you have some sort of immunological deficit.   Dr. John Sweetenham: Yeah. I'm going to switch gears now and return to the first thing that you mentioned right up front, which is the issue of equity and how we are going to address equity issues in the coming year. I think that in many ways, 2020, going into 2021, has been 2 years where issues of equity in health care have really come to the fore. And of course, there's been a great deal of discussion around this.   And I think you'd agree with me that we've seen, at the same time, that some of the strategies that we have been using during the COVID-19 pandemic, including telehealth, which one would have hoped would be a great equalizer, actually has the potential to exacerbate some of the disparities that we've been seeing in health care. But you mentioned analysis paralysis, and just to pick up on that theme, despite the huge amount of coverage that equity has received in medical journals and the media, where do you think we actually are in finally truly addressing some of the cancer care disparities that we see?   Dr. Derek Raghavan: Well, I think, John, you know that I was one of the early chairs of the ASCO Task Force. Otis Brawley and I chaired that task force together. Very early in the piece, I'm going to say probably 15 years ago, we wrote really quite a strong position paper on this whole issue. And so, we got started early in doing stuff on what we thought would be important, and we did, with support from the Komen Foundation, was to start training people of color in the oncology space and keeping them working in underserved communities by paying off their college loans for the period of time that they did that.   So, people have been doing stuff for a while. I think what's happened in the last decade, and it has been a slow change, is that there's been more a move to saying, let's get started. So, if you look at Chris Lathan up at Harvard, at one of their underserved hospitals, if you look around the country, consider the Bristol Myers Squibb Foundation, which puts money into active projects that are about doing stuff rather than having meetings to consider doing stuff. I think there's been that swing.   Dr. John Sweetenham: When we think about equity and disparities of care, we're often drawn towards the cost of cancer care and how much that plays into disparities and inequity in the delivery of cancer care. And picking up on that theme that you mentioned around value, cost and price, and maybe we could think about linking that with the use of CAR T-cell therapy and the application of CAR T-cells in the solid tumor world, if that is going to happen, what do you think we can do during 2022 to confront some of the cost and price issues that we're seeing within our cancer care environment right now?   Dr. Derek Raghavan: Well, I sometimes think in a utopian fashion, which doesn't get me very far, I have to say. What I'd love to see in the United States, because we spend far more money on everything health-wise than any other country in the civilized or uncivilized world, but what I'd like to see is a bipartisan initiative run by people who actually understand health care and health care economics that would go to the issue of, how do you get better bang for your buck? And it would include doing some tough things.   We waste money outrageously. We'll treat third-line metastatic pancreas cancer off trial. Nothing works in third-line metastatic pancreas cancer off trial. It's worth maybe a clinical trial to help the next person in line. That's how we make progress. But just to keep giving the same old litany of drugs in the hope that it might work is a waste of money. As I talked about before, BMT for breast cancer turned out to be a huge waste of money over a long period of time. So, if you can actually create a scenario where government set some rules and took the courageous, and this why it would have to be bipartisan, it would actually start to rationalize health care.   You know, John, the Oregon experiment many years ago, where one party started to rationalize care, and the other party accused them of rationing care. I mean, you can't have that happen. We've also seen both sides allocate the task of developing health care algorithms to people who are great politicians but know nothing about health care or economics. So, I mean, there are easy ways to do it. What we can do ourselves is be honest. Tell people what bang they'll get for their buck.   The person who is likely to have, say, an 80% chance of being dead within 4 months may not wish to mortgage his house if he's told that. On the other hand, he might well want to mortgage his house if he thinks that a very expensive treatment will give him the chance of being alive in 5 years. So, we, as physicians, shouldn't make that decision. It's the patient's right to be able to choose life versus the life of their offspring and spouse and future generations. So, I think it's not that complex, and I think if we brought more transparency about good expectations versus poor expectations, gave a better reason for patients getting more involved in trials, we're still at less than 15% of patients with cancer in the USA getting involved in trials, and that's a tragedy.   Dr. John Sweetenham: Yeah, I think also, the other thing that's occurred to me in this context, is the fact that while we tend to hone in on costs of treatment when we get into these discussions, I've been seeing some emerging literature around the cost of follow-up and unnecessary follow-up and imaging and so on in those patients who are in survivorship part of their cancer journey. And there's a huge opportunity there, I think, for us to reduce costs of care with no impact whatsoever on survival, no difficult treatment decisions to be made because we're simply doing an enormous amount of unnecessary testing in these patients who have completed treatment that we know doesn't impact survival. So, I do think that we could take a really serious look at that and make very significant savings. So, I think there's lots of potential there too.   Dr. Derek Raghavan: Yes. I agree, John. And I'd actually give kudos to ASCO in this space because they were early adopters of the Choosing Wisely campaign. They wrote two sets of guidelines about stupid things that we do that make no difference. And to be honest, I think that--I was on that committee, and the committee got tired.   I was one of the few people that actually felt we should keep going and very actively keep issuing guidelines of things that just aren't worth doing and having symposia at the ASCO ASM say that the symposia that are entitled “How to Waste Money” or alternatively entitled “How to Stop Doing Dumb Stuff” would be really quite important. And it would give the basis for sensible medicine to people who do medical legal protection work. So, most people who do multiple PET scans on lymphoma where the patient is completely well and blah, blah, blah are doing it for medical-legal reasons. They're not doing it because they think it will make a huge difference.   And I, of course, am not talking about the people where they're following PET scans as markers of response. So, I think we can do this work. I'd love to see a presidential campaign which is about not doing dumb stuff and where ASCO takes the bully pulpit and says, “we're spending a year policing ourselves, talking about all the things we do that don't actually make things better for patients.”   Dr. John Sweetenham: So, let's extend this theme of expensive therapies. And you mentioned CAR T-cell therapy. And in the hematologic malignancy world, we're now just beginning to see 1 or 2 results, which will be presented at the American Society of Hematology meeting in a couple of weeks from now, positive results from a couple of randomized clinical trials in hematologic malignancy with CAR T-cell therapy. So, what are your thoughts on the application of this treatment in the solid tumor world, and where do you think we are, what do you think we might see during 2022?   Dr. Derek Raghavan: Well, let's talk strategy first. I think a good place to begin is with a good scientific hypothesis. So, we both know how CAR T[-cells] work. We don't have to have a long discussion here about them. It would be patronizing to the audience. But you might think about, what solid tumor is actually going to benefit from immunological manipulation? Where have the checkpoint inhibitors been helpful, and where have they not been helpful? And so, you might focus the initial part of CAR T[-cells] and solid tumor work on those where there's a hypothesis that makes sense.   Then the second thing you could do would be to actually come to the companies that make all their money from CAR T[-cells] and say, perhaps you could invest in this research with us, and we'll do a couple of Hail Mary passes. So, let's look at the tumors where there isn't a good hypothesis, but nothing works, and see if we can get an experience. So, that'd be a nice, simple, easy way to do it. And then measure tight outcomes, have very robust entry criteria so you don't get confused about various toxicities because you're actually starting with patients in reasonable shape and then expanding to all populations.   So, the first part would be phase 1 and 2. Then you, early in the piece, make sure that you have inclusiveness so that you know all the population groups that might benefit from the treatment. I think that'd be a reasonable way to go.   Dr. John Sweetenham: Talking about identifying targets appropriately and target populations for treatment, you had mentioned as one of your other challenges for 2022 the concept around identifying molecular subgroups and molecular prognostication as a way of patient selection. So, could you say a little bit more about that and what you think we're going to need to do in the coming year in terms of refinement of targets?   Dr. Derek Raghavan: Well, John, this is an area of your expertise as well, coming from the hematological malignancy world. Now, I hope we would both agree that having robust reproducible technology is important. The fact that there are so many molecular diagnostic companies that hype their product doesn't necessarily mean that the product is good. So, there needs to be standardization of approaches to using technology, to measuring outcomes.   We need to have comparative sets of data, looking at different technologies to see how they work, and those sorts of studies need to be funded by government because there's no particular reason for the companies to agree to perhaps show that their diagnostic technology is not as good as somebody else's. But this would be a good initiative for the government to actually start to rank order of the products that are out there. I, frankly, think when you think of the impact of all of these molecular diagnostic tests, I've never understood why so many of them are out there without tight U.S. Food and Drug Administration (FDA) regulation. So, I think that's a place to begin.   If you think back to the old breast cancer days when there was immunohistochemistry and a bunch of molecular technologies, the outcomes were so varied when compared on common tumor samples. So, we just seem to be quite comfortable to make the same set of mistakes again. I do think there are responsible investigators doing excellent work in the space, so I'm not critical of the space. I'm answering the question, which is we need now to bring some regulation in to ensure that the quality of the work, reproducibility of the work. You'll even see, and I know you and I have talked about this in the past, there'll be Mr. X who has prostate cancer and gets his PSA measured, which is Prostate-Specific Antigen, looking at how active the cancer is regularly in different labs. That makes absolutely no sense. There's no common standard. PSA in my lab is going to be different from PSA in your's. And so there just should be some nice, simple rules of how to use molecular testing in an optimized fashion.   Dr. John Sweetenham: Yeah, and I wonder also whether we need to be looking a little bit more closely at point of care clinical decision support for some oncologists who may not be as molecularly literate as others because I do think that's another real challenge at the moment is giving guidance to everyone who might see these patients in terms of treatment selection.   Dr. Derek Raghavan: Well, I agree with you completely. I mean, kudos to the major companies because most of them provide pretty good decision support. One with which we worked tended to be a little too positive about its product, and we worked to change that. And now they're actually very useful. We have a big series from our molecular tumor board here that runs over I think a 5-year period that Carol Farhangfar, PhD, has just submitted for publication, which shows that you can heavily influence people who are out in the community by providing centralized support for their use of molecular diagnostic tests. But again, we only deal with the major companies so that we think there's good quality control there. And we don't flip back and forth in an individual patient between one company and another.   Dr. John Sweetenham: Right. Well, I think we're almost out of time, Derek, but I did want to ask you one more question, and it's a real change of gear. But over the last year or so, I think that probably largely because of the COVID-19 pandemic, we have seen some exacerbation of workforce issues in the oncology workforce that we knew already existed. I think there is undoubtedly more burnout being reported than there was before. Certainly, within our own organization, we have seen some increased staff turnover and a number of people who I think, frankly, have realized that they want to move closer to their families.   And so, there's been a certain amount of churn, which I think many of us in cancer centers are experiencing. Interested to know whether you've seen anything similar and what strategies you're using in terms of staff retention and oncology clinician burnout at your center.   Dr. Derek Raghavan: I think this is a difficult problem. The morale at the Levine Cancer Institute, much like the Simmons Cancer Center, is high, and that's driven by the leadership cadre being out there with their troops, visible and actively engaged so that the troops on the line feel that the bosses are part of the deal. And we do silly little things that matter, which is parties and celebrations and thank yous and all that sort of stuff. We get the staff to thank each other. We encourage the patients to thank the staff just with an attaboy or something that just says we appreciate the care.   So, I think this is a challenge. I do think work-life balance in old geezers like you and me has been a slightly different thing from some of the younger physicians who are spending, I think sensibly, more time with their families and don't want to spend these long hours. I think the other thing is there is still a town-gown issue where there are people who can make a lot more money much more quickly in some parts of non-academic practice, and it's getting harder to publish in academic practice, so the rewards for that are slipping a little.   I actually don't really have a solution. I think that the august colleges drawing to the attention of the world that this is a big deal and engaging bipartisan support from the political machinery will be important. I think ASCO can, through its government relations people (ASCO Advocacy), continue to prosecute these issues, which they do. I think there is the mistake that we make in the cancer space is we do still tend to compete between societies.   I've always thought it would be much healthier to have ASCO, ASTRO, ACS, SUO, SSO and all those people having a common council that speaks on this sort of issue with one voice and draws to attention of the people out there that this is a big issue. The best of the doctors (docs) are getting older. The younger docs come through the Taylor laws are less experienced and less well-trained and have a different ethos. So, we're going to lose an aspect of practice that's been part of the tradition of medical practice since the time of Osler, and it's definitely going away.   I have a superb physician fellow working with me at the moment who I would rate as one of the best 3 in 10 years. The reason she's one of the best 3 in 10 years is she practices the style of medicine that my fellows did 25, 30 years ago, most of whom are now professors of medicine somewhere. And good with patients, knows her staff, does research, and somehow manages to have reasonable time for a family. That tradition is starting to go away, and I don't think there is a simple change. And then the final point, the people who run health care today see it as a business. I was in a meeting recently outside my own domain where someone said, you know, I have to figure out whether medicine is really importantly a health care business or whether it's an IT business focused on health care. And that's going to start to lose the human side of medicine. We spent some time on that today. The outcomes will go down if this is just a business.   Dr. John Sweetenham: Well, thanks, Derek. Really appreciate all of your insights today. I think there's no doubt that 2022 is going to be a year of many challenges for those of us in the oncology community and for our patients, but I think it's also inevitably going to be a very exciting year in terms of new developments.   And hopefully, if we're recording another podcast like this in a year from now, the COVID-19 pandemic will be a little bit more in the rearview mirror, and we will be able to focus on many of the other important issues that face us. So again, really appreciate your sharing your insights with us, and wish you all the best for 2022.   Dr. Derek Raghavan: John, always a pleasure chatting, and the same to you and Caroline and the family.   Dr. John Sweetenham: Thank you. And thanks to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclosures: Dr. John Sweetenham: Consulting or Advisory Role: EMA Wellness   Dr. Derek Raghavan: Consulting or Advisory Role: Gerson Lehrman Group, Caris Life Sciences   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guests' statements on the podcast do not express the opinions of ASCO.  The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Charlottesville Community Engagement
December 16, 2021: Charlottesville PC recommends more funding for affordable housing, new sidewalks; Pinkston, Wade take oath of office for Council

Charlottesville Community Engagement

Play Episode Listen Later Dec 16, 2021 24:24


We’re now less than a week away from the solstice, which takes place at precisely 10:59 a.m. on December 21 on the eastern coast of the United States. Until then we’ve got a few more days of lengthening night before the pendulum shifts back to light and the march to 2022 continues with new energy. Between now and then there will be a few installments of Charlottesville Community Engagement and this is the one for December 16, 2021. I’m your host, Sean Tubbs.Charlottesville Community Engagement is a great way to find out about what’s happening and how you can get involved It’s free to sign-up, but there are many opportunities to support the work!On today’s show:Brian Pinkston and Juandiego Wade are officially sworn in as City Councilors, as well as members of the Charlottesville School BoardVirginia Tech and a Richmond consortium have both been awarded half-million grants for economic development A pair of transit updates, including the fact that Charlottesville Area Transit will remain fare-free for four years The Charlottesville Planning Commission provides direction on Charlottesville’s next capital budget In today’s first Patreon-fueled shout-out, Code for Charlottesville is seeking volunteers with tech, data, design, and research skills to work on community service projects. Founded in September 2019, Code for Charlottesville has worked on projects with the Legal Aid Justice Center, the Charlottesville Fire Department, and the Charlottesville Office of Human Rights. Visit codeforcville.org to learn about those projects. COVID UpdateThe number of new COVID cases in Virginia continues to climb, but the percent positivity has dipped slightly. This morning the Virginia Department of Health reported another 3,688 new cases and 102 of those are in the Blue Ridge Health District. Statewide the seven-day percent positivity is 8.5 percent and in the BRHD it’s at 7.2 percent. New elected officials sworn-inThere are still 15 days left in 2021, and City Councilors Heather Hill and Nikuyah Walker have one more meeting on Monday. The near future became a little closer on Wednesday as two incoming City Councilors and three members of the Charlottesville School Board took the oath of office on the steps of Charlottesville Circuit Court. The School Board went first with newcomers Emily Dooley and Dom Morse sworn in individually with family members at their side. Second-termer Lisa Larson-Torres went next. Then it was time for City Councilor-elect Brian Pinkston followed by Juandiego Wade. I asked both if they are ready to take on the task. “You know, I think I’m as ready as I’ll ever be,” Pinkston said. “I joke that it’s a little like getting married or having a kid. You think what you’re getting into but it’s not what you expected. There’s good part and bad parts to that and so the short answer is yes. I’m ready. I’m excited about it. I’m going to roll up my sleeves and try to make a difference.” “I’m ready, I am prepared,” Wade said. “I feel like I’ve been preparing for this for the last years being connected and involved in the community. I feel like now is an opportunity for me to take my service and my commitment to the city to a different level.” In a separate ceremony that also took place yesterday morning, the members of the Albemarle Board of Supervisors were also sworn in, including newcomer Jim Andrews, who will represent the Samuel Miller District. Andrews joined third-term Supervisor Diantha McKeel (Jack Jouett) and two-term Supervisor Ned Gallaway (Rio). Transit updatesIn yesterday’s newsletter, there’s a lot of information about planning for a Regional Transit Vision that may include formation of an authority that could raise funds for expanded service. There’s also a second study underway to determine the feasibility of additional routes to serve urbanized portions of Albemarle County as well as Monticello. The results are in from a survey conducted on two potential scenarios according to Lucinda Shannon, a transportation planner with the Thomas Jefferson Planning District Commission. (project website)“They found that most of the services that people selected in that public outreach was scenario 2 for all three of the areas which is a lot of microtransit connecting with some fixed routes,” Shannon said. The study also found that 98 percent of people who travel to Monticello do so in a car that they either own or rent. That’s based on 51 respondents. The U.S. 29 North survey got 104 responses and the Pantops survey got 54 respondents. The consultants hired for this project are Michael Baker International and Foursquare ITP. The next step is a Board of Supervisors meeting on January 19, according to Shannon. Charlottesville Area Transit will remain fare-free for the next four years. The Virginia Department of Rail and Public Transportation awarded a $1.07 million grant through the Transit Ridership Incentive Program. CAT had already put some of the American Rescue Plan Act funding for this purpose, and the new grant covers fares for an additional year. CAT Director Garland Williams said he anticipates planned route changes will soon be implemented. The adjustments have been through the public process. Williams briefed the Regional Transit Partnership at their meeting on December 2. “We’re still moving forward and hoping to be able to implement in January unless something changes,” Williams said. Learn more about those route changes on the Charlottesville Area Transit website at catchthecat.org. In other news, Jaunt’s new chief executive officer has named Karen Davis the transit agency’s Deputy Chief Executive Officer. Davis served as interim CEO for exactly a year after the Board asked former CEO Brad Sheffield to resign. Ted Rieck started work as CEO earlier this month after heading a similar transit agency in Tulsa, Oklahoma. *Infrastructure grantsTwo entities in Virginia have been awarded $500,000 planning grants from the federal government to increase infrastructure necessary to increase commerce and trade. The U.S. Economic Development Authority awarded Build Back Better Regional Challenge awards to Virginia Tech and the Virginia Biotechnology Research Partnership Authority for initiatives that seek to create “regional industry clusters.” Virginia Tech’s application is called The Future of Transportation Logistics and covers a wide section of southwest and southern Virginia. The idea is to accelerate the adoption of electric and automated vehicles. “Projections by the World Economic Forum expect freight demand to triple by 2050,” reads their application. “This growing demand poses challenges from environmental degradation to a strained transportation workforce.”The New River Valley region includes three truck manufacturers, including the national headquarters for Volvo. The work will involve building a coalition to share information as well as demonstration projects such as upgrading a section of Interstate 81 between Salem to Dublin to accommodate automated vehicles. The Virginia Biotechnology Research Partnership Authority covers the Richmond and Petersburg area and is intended to create an Advanced Pharmaceutical and Research and Development cluster. “A staggering 73% of Food and Drug Administration (FDA)-registered active pharmaceutical ingredients (API) manufacturing facilities are located outside the United States,” reads that application. ”Overseas pharmaceutical manufacturing not only poses a security risk but also takes essential jobs away from the U.S.”Both entities will now be eligible to apply for additional funding from the U.S. Economic Development Authority to implement the projects. Thanks to Route 50 for the information on this grant program. (read their article)In today’s second subscriber-supported public service announcement: The Charlottesville Jazz Society at cvillejazz.org is dedicated to the promotion, preservation, and perpetuation of all that  jazz, and there’s no time like now to find a time to get out and watch people love to play. The Charlottesville Jazz Society keeps a running list of what’s coming up at cvillejazz.org. Sign up for their newsletter today. Tree canopy declineAt their meeting on Tuesday, the Charlottesville Planning Commission held three public hearings on three big topics. But first, they got updates from various committees. Commissioner Jody Lahendro and he relayed news from the Tree Commission about the forthcoming tree canopy study. A preliminary report states that the percentage of the city covered by trees has shrunk by at least four percent since 2015. “Because of COVID, the flyover for this tree canopy study was done in 2018 so it’s dated now,” Lahendro said. “The news is not great as you might imagine.” Lahendro said the city had a tree canopy of 50 percent in 2004 and that declined to 47 percent in 2009. “In 2014 it went down to 45 percent and in 2018, this latest, it’s to 40 percent,” Lahendro said. When you break the city down by neighborhood, nine out of 19 recognized areas are below 40 percent. Lahendro said that is the point where both health and economic development is affected.“And then two of our districts — Starr Hill and 10th and Page — are below twenty percent,” Lahendro said. “Those are where significant detrimental effects are happening.” Lahendro said the city is projected to lose 360 ash trees to emerald ash borers over the next five years. The city can only afford to treat 30 trees. Charlottesville’s FY23-27 CIP discussionThe Charlottesville City Planning Commission has made its recommendations for how to amend the draft capital budget for the next five years. That came at the end of a public hearing Tuesday that featured a discussion with City Council. Elected officials will make the final decision next spring as they adopt a budget that will be prepared under the supervision of a yet-to-be-named interim city manager. (draft FY23-FY27 CIP presentation to Planning Commission) (adopted FY22 budget)The Commission got a look at the information at a work session on November 23, and heard it a second time from Senior Budget Analyst Krissy Hammill in advance of the public hearing. To recap, the capital budget is close to capacity due to the increase of spending in recent years, including a $75 million placeholder for the reconfiguration of middle schools. Council has also authorized a reorientation of priorities to find more money for the schools project. (previous story)“There were some large projects that were previously authorized to use bonds for that we unfunded essentially to be able to move them to get us to a place where we could increase the $25 million for the school project,” Hammill said. “That was the West Main Street project which was originally in the CIP at $18.25 million and the 7th Street Parking Garage which we unfunded about $5 million of that project.”Hammill said to pay for the projects, the city will need additional revenue and will not be able to add any more capital projects for many years unless they are paid for in cash. The city has had a AAA bond rating from Standards and Poor since 1964 and from Moody’s since 1973. “Essentially the AAA bond rating gives the city the opportunity to borrow money at the lowest cost available so that means that more dollars are going to the projects and less dollars are going towards interest,” Hammill said. Hammill said the city is in good financial shape, but funding future investments will be a struggle. At the work session, Hammill invited ideas for further reallocations from other projects. She also said that the Infrastructure Investment and Jobs Act will likely not be a salvation for the city. “Many of us in finance have sort of been waiting in the wings to find out what would be available and it’s actually not a one size fits all and it doesn’t deliver on a lot of what we already have in our CIP,” Hammill said. “So it not going to help us address our financing problems largely.”Another issue is that many of the funding sources will require local matches. She pointed out one opportunity for Charlottesville Area Transit to raise up to $37 million, but the city would have to provide a $2 million match.“That’s not in our curent CIP,” Hammill said. Revisising the Strategic Investment AreaThe two bodies discussed many aspects of the capital budget, including whether or not several general interest line items should be given additional funds in the next year’s budget. Councilor Lloyd Snook questioned one of them related to a 2013 small area plan known as the Strategic Investment Area. “One example would be that we’re suggesting another $200,000 for this coming year and three years beyond that for the [Strategic Investment Area] immediate area implementation,” Snook said. “And that balance in that account is over a million and has been as far as I can tell over a million dollars for quite a while.”Alex Ikefuna, the interim director of the Office of Community Solutions and former director of Neighborhood Development Services, said that balance has been used to pay for a $228,000 study of a form-based code for the area. Nolan Stout reported in the February 4, 2020 Daily Progress on the current Council’s decision to put that plan on hold indefinitely. Ikefuna pointed to one example of how the funding in the account will be used.“We have a Pollocks Branch pedestrian bridge which is currently being finalized for construction,” Ikefuna said. “There are several other project within the SIA that consume that balance.”One of them is a project to upgrade the streetscape on Elliot Avenue in an area where dozens of new homes have been built in the Burnet Commons area. The public housing site at South First Street is also expanding in residential density. Ikefuna also said the SIA fund could also be used for additional costs that may be incurred at Piedmont Housing Alliance’s redevelopment of Friendship Court. “Part of the Friendship Court project includes infrastructure improvement because they have to break up that neighborhood and then integrate that into the city’s grid,” Ikefuna said. “And they may have a cost overrun.”Council approved $5.5 million for the project in October 2020. (read my story)The current year’s capital budget allocated $2 million in cash for the line item of “Friendship Court Infrastructure Improvements” as well as $394,841 for Phase 1 and $750,000 for Phase 2. The draft five-year capital plan anticipates spending $2.5 million on Phase 2 in FY23, and a total of $3.25 million for phase 3 and $4.5 million for Phase 4. Ikefuna also said there’s a project called the Elliott Avenue Streetscape for which a design is almost complete. Snook said Council is not given information about what any of these plans are. “I assume somebody has a plan but it’s not been revealed to us,” Snook said. “I look at the next item. Small area plans. We’re putting in another $100,000 in and the balance of the project is $496,000.” Outgoing City Councilor Heather Hill had one suggestion for where that funding could go. In July 2020, Council chose to proceed with a Smart Scale project over the opposition of some nearby residents and businesses. (July 22, 2020 story on Information Charlottesville)“The Grady / Preston / 10th intersection area related to one of the VDOT projects for Smart Scale funding was identified at that time as something we would want to have more planning around because there was a lot of resistance that there wasn’t a lot of community engagement when that proposed plan was coming to fruition,” Hill said. According to the application for that project, the preliminary engineering phase will not begin until December 2025. There is no design for the Smart Scale project, which was funded on a set of parameters. “Preston Avenue will be realigned to create a consolidated intersection at Preston Avenue / Grady Avenue / 10th Street,” reads the application. “New sidewalks will be constructed throughout the project limits.”Hoping for a sales tax referendumSeveral commissioners expressed concern about the enormity of the school reconfiguration project. The draft plan shows $2.5 million in FY23 and $72.5 million in FY24. Hammill has previously said the money needs to be in place when a contractor is hired for new construction and renovation of Buford Middle School. The school project has not yet come directly before the Planning Commission. “The amount of that project is the entirety of the five-year [capital] FY2017 budget,” Stolzenberg said. “It’s this elephant in the room but it does seem like Council and the School Board have approved the project.” The idea of a dedicated one-cent sales tax increase has been floated to be dedicated funding for the project, but the General Assembly will have to approve a bill allowing Charlottesville voters decide on whether to impose it.“I really, really hope that if we go through with it that the sales tax comes through and frees us from this burden,” Stolzenberg said. Later in the meeting, Commissioners discussed several potential recommendations. One was whether to recommend increasing the amount for affordable housing. Here’s what’s in the proposed CIP. $3 million for the Charlottesville Redevelopment and Housing Authority in FY23, and $9 million in the out yearsA base of $925,000 a year into the Charlottesville Affordable Housing Fund $900,000 a year to the CRHA to administer additional housing vouchers $2.5 million for the second phase of Friendship Court In March, Council adopted an affordable housing plan that set an ambitious spending target for each year, as noted by Stolzenberg. “It’s recommendations are pretty clear,” Stolzenberg said. “Ten million a year. $2 million are tax relief. A million to administration. So it’s really $7 million in direct subsidy and that’s all on page 49 of the plan for reference.” Here’s what the PC’s recommendations are:Reduce funding for the 7th Street parking structure funding to the minimum amount necessary to satisfy Charlottesville’s commitment to provide parking for Albemarle County per a 2018 agreement related to the joint General District Court that will be under construction.Find more more funds for the line items of tree planting, new sidewalks, and bicycle infrastructure, and hazardous tree removal. Reduce funds going to the line item for economic development strategic initiatives, small area plans, and Strategic Investment Area implementationFully fund the Stribling Avenue sidewalk project that Southern Development has agreed to pay upfront for as part of a rezoning that Council will consider in early 2022.Explore ways to add enhancements to the Drewary Brown Bridge to honor the Bridge Builders, potentially using a portion of funds for the West Main Streetscape. Increase budget for Charlottesville Affordable Housing Fund and find ways to fund housing requests that were requested but not included in the draft budget, possibly directing any budget surpluses for this purpose. On Monday, City Council will hold first of two readings on a proposal to reallocate the $5.5 million surplus from FY21 to employee compensation and bonuses. They’ll also consider the transfer of $6.7 million in cash from a COVID reserve fund into the Capital Improvement Plan Contingency Fund. (staff report) This is a public episode. Get access to private episodes at communityengagement.substack.com/subscribe

Breaking Down Biosimilars
Ep 5- The Price and Hoops to Saving Money

Breaking Down Biosimilars

Play Episode Listen Later Dec 15, 2021 14:38


When biosimilars were introduced into the US, there was much talk about how much money they could potentially save patients. Getting a biosimilar developed and approved by the US Food & Drug Administration (FDA) is not as rigorous or time-consuming as for a biologic … which was touted as being more economical. And insurance companies were supposed to pass along savings to consumers. In this episode, Zoe and Conner look at why that hasn't happened to any large degree, and what can be done about it. “I think there's going to be a healthy competition on pricing that we haven't had until now,” says Dr. Simon Helfgott, rheumatologist at Brigham & Women's Hospital in Boston. Among the highlights in this episode: 2:40 – Why the big savings haven't materialized 4:25 – What happens when insurance companies arbitrarily change biosimilar coverage 5:21 – Options available to patients 7:03 – How competition could ultimately help consumers 8:49 – Pharmacy benefit managers, and why they don't benefit patients 11:00 – Rebate contracting, and how it keeps the market share for biosimilars low 12:24 – The good news: Slightly more aggressive pricing structures, and lower costs for some employees Contact Our Hosts: Zoe Rothblatt, Patient Advocate and Community Outreach Manager at GHLF. zrothblatt@ghlf.org Conner Mertens, Patient Advocate and Community Outreach Manager at GHLF. cmertens@ghlf.org We'd love to hear what you think. Send your comments to BreakingDownBiosimilars@GHLF.org See omnystudio.com/listener for privacy information.

Loving Liberty Radio Network
12-11-2021 Liberty RoundTable with Sam Bushman

Loving Liberty Radio Network

Play Episode Listen Later Dec 12, 2021 109:37


Hour 1 * WHO: No Deaths Reported as a Result of Omicron Variant to Date – TheEpochTimes.com * Fauci in an MSNBC interview with Andrea Mitchell on vaccine mandates: ‘Communal good' trumps ‘individual choices' – ‘We really have to get people vaccinated' – Art Moore, WND.com * Why You Can't Find Cheap At-Home COVID-19 Tests – While cheap tests are easily available overseas, Americans are left with few options – Rachana Pradhan and Hannah Norman – The Food and Drug Administration (FDA) had received more than 3,000 emergency use authorization applications, and it didn't have the resources to get through them. * Free pizza has gone from being a Student Body President's campaign promise to a lure used by the Los Angeles Unified School District to get students vaccinated without their parents' permission – The school employee then told the student not to tell his mom, or they would both get in trouble. * BUSTED—Military Memo Leaked – Joe Biden's Department of Defense (DOD) is acting like it is above the law. But this lawlessness will have to answer to the court in our class action lawsuit, Navy SEAL 1 v. Biden – As you know, Liberty Counsel is representing service members against Biden's shot mandates. Hour 2 * Natural Immunity More Protective Over Time Than COVID-19 Vaccination: Study from Israel – Zachary Stieber. * “If you had COVID before and recovered, all the data that we're looking at will suggest that you have bulletproof natural immunity, which is much more robust and comprehensive than vaccine immunity,” Dr. Paul Alexander, an epidemiologist with the Early COVID Care Experts who has compiled 141 studies on natural immunity—including a major study from Israel published in August—told The Epoch Times. * “There is little benefit from getting vaccinated after recovery from COVID,” Dr. Harvey Risch, an epidemiology professor at the Yale School of Public Health, told The Epoch Times. * It's More Than Time To FIRE Fauci! * Facebook admits its ‘fact-checks' are nothing but someone's opinion – Concession appears in court document – Bob Unruh, WND.com * Meta Attorneys: Facebook Fact Check Labels Are Opinion – TheEpochTimes.com * Television host John Stossel sued Facebook and two of its fact-checking partners, Science Feedback and Climate Feedback, earlier this year, accusing the entities of defaming him. * The labels themselves are neither false nor defamatory; to the contrary, they constitute protected opinion – FB Attorney's. * We're Suing Twitter and We Need Your Help – Attorney Harmeet Dhillon. * Mark Meadows Sues Nancy Pelosi and Jan. 6 Panel – Unauthorized access. * Tornadoes Rip Through Multiple States, Death Toll is Rising. * US Inflation Hits Highest Level in Almost 40 Years as Biden Policies Decimate the Economy. * Biden Distances Himself from Push to Defund Police as Blue States See Spike in Crime. --- Support this podcast: https://anchor.fm/loving-liberty/support

Liberty Roundtable Podcast
Radio Show Hour 1 – 12/11/2021

Liberty Roundtable Podcast

Play Episode Listen Later Dec 11, 2021 54:49


* WHO: No Deaths Reported as a Result of Omicron Variant to Date - TheEpochTimes.com * Fauci in an MSNBC interview with Andrea Mitchell on vaccine mandates: 'Communal good' trumps 'individual choices' - 'We really have to get people vaccinated' - Art Moore, WND.com * Why You Can't Find Cheap At-Home COVID-19 Tests - While cheap tests are easily available overseas, Americans are left with few options - Rachana Pradhan and Hannah Norman - The Food and Drug Administration (FDA) had received more than 3,000 emergency use authorization applications, and it didn't have the resources to get through them. * Free pizza has gone from being a Student Body President's campaign promise to a lure used by the Los Angeles Unified School District to get students vaccinated without their parents' permission - The school employee then told the student not to tell his mom, or they would both get in trouble. * BUSTED—Military Memo Leaked - Joe Biden's Department of Defense (DOD) is acting like it is above the law. But this lawlessness will have to answer to the court in our class action lawsuit, Navy SEAL 1 v. Biden - As you know, Liberty Counsel is representing service members against Biden's shot mandates.

American Conservative University
Dr. Harvey Risch: Hydroxychloroquine, Ivermectin, and Other Therapeutics Highly Effective in Early COVID Treatment.

American Conservative University

Play Episode Listen Later Dec 11, 2021 60:33


Dr. Harvey Risch: Hydroxychloroquine, Ivermectin, and Other Therapeutics Highly Effective in Early COVID Treatment. American Thought Leaders  Dec 01 2021  60 mins     “These drugs have been suppressed… for reasons that have nothing to do with the science and the medicine.” In this episode, we sit down with Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health and Yale School of Medicine. He says therapeutics, including https://www.theepochtimes.com/t-hydroxychloroquine (hydroxychloroquine) and ivermectin, can be highly effective against COVID when they are deployed early on and in combination with different medications. In the interview, Dr. Risch criticized the U.S. Food and Drug Administration (FDA) for warning against hydroxychloroquine and chloroquine use to treat COVID-19 and revoking the emergency use authorization (EUA) for hydroxychloroquine and chloroquine. The FDA told The Epoch Times in an email that the FDA made this decision after https://www.fda.gov/media/138945/download (testing) the efficacy of hydroxychloroquine for treating COVID-19, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/MemorandumDecliningRequestforHCQEUA_081020.pdf (including) in patients in an outpatient setting. But Dr. Harvey Risch argues that outpatient reports are exceedingly few because the medication is extremely safe and the emergency use authorization in March 2020 blocked outpatient use, and he believes the FDA has conflated heart rhythm problems from severe COVID infection with adverse effects from hydroxychloroquine use in hospitalized patients. Subscribe to the American Thought Leaders https://ept.ms/ATLnewsletter (newsletter) so you never miss an episode. Follow http://epochtv.com/ (EpochTV) on social media: Facebook: https://www.facebook.com/EpochTVus (https://www.facebook.com/EpochTVus) Twitter: https://twitter.com/EpochTVus (https://twitter.com/EpochTVus) Rumble: https://rumble.com/c/EpochTV (https://rumble.com/c/EpochTV) Gettr: https://gettr.com/user/epochtv (https://gettr.com/user/epochtv) Gab: https://gab.com/EpochTV (https://gab.com/EpochTV) Telegram: https://t.me/EpochTV (https://t.me/EpochTV) Parler: https://parler.com/#/user/EpochTV (https://parler.com/#/user/EpochTV)   HELP ACU SPREAD THE WORD!  Please go to Apple Podcasts and give ACU a 5 star rating. Apple canceled us and now we are clawing our way back to the top. Don't let the Leftist win. Do it now! Thanks. Forward this show to friends. Ways to subscribe to the American Conservative University Podcast Click here to subscribe via Apple Podcasts Click here to subscribe via RSS You can also subscribe via Stitcher FM Player Podcast Addict Tune-in Podcasts Pandora Look us up on Amazon Prime …And Many Other Podcast Aggregators and sites   Please help ACU by submitting your Show ideas. Email us at americanconservativeuniversity@americanconservativeuniversity.com Please go to Apple Podcasts and give ACU a 5 star rating. Apple canceled us and now we are clawing our way back to the top. Don't let the Leftist win. Do it now! Thanks.

American Conservative University
Dr. Harvey Risch: Hydroxychloroquine, Ivermectin, and Other Therapeutics Highly Effective in Early COVID Treatment.

American Conservative University

Play Episode Listen Later Dec 11, 2021 60:33


Dr. Harvey Risch: Hydroxychloroquine, Ivermectin, and Other Therapeutics Highly Effective in Early COVID Treatment. American Thought Leaders  Dec 01 2021  60 mins     “These drugs have been suppressed… for reasons that have nothing to do with the science and the medicine.” In this episode, we sit down with Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health and Yale School of Medicine. He says therapeutics, including https://www.theepochtimes.com/t-hydroxychloroquine (hydroxychloroquine) and ivermectin, can be highly effective against COVID when they are deployed early on and in combination with different medications. In the interview, Dr. Risch criticized the U.S. Food and Drug Administration (FDA) for warning against hydroxychloroquine and chloroquine use to treat COVID-19 and revoking the emergency use authorization (EUA) for hydroxychloroquine and chloroquine. The FDA told The Epoch Times in an email that the FDA made this decision after https://www.fda.gov/media/138945/download (testing) the efficacy of hydroxychloroquine for treating COVID-19, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/MemorandumDecliningRequestforHCQEUA_081020.pdf (including) in patients in an outpatient setting. But Dr. Harvey Risch argues that outpatient reports are exceedingly few because the medication is extremely safe and the emergency use authorization in March 2020 blocked outpatient use, and he believes the FDA has conflated heart rhythm problems from severe COVID infection with adverse effects from hydroxychloroquine use in hospitalized patients. Subscribe to the American Thought Leaders https://ept.ms/ATLnewsletter (newsletter) so you never miss an episode. Follow http://epochtv.com/ (EpochTV) on social media: Facebook: https://www.facebook.com/EpochTVus (https://www.facebook.com/EpochTVus) Twitter: https://twitter.com/EpochTVus (https://twitter.com/EpochTVus) Rumble: https://rumble.com/c/EpochTV (https://rumble.com/c/EpochTV) Gettr: https://gettr.com/user/epochtv (https://gettr.com/user/epochtv) Gab: https://gab.com/EpochTV (https://gab.com/EpochTV) Telegram: https://t.me/EpochTV (https://t.me/EpochTV) Parler: https://parler.com/#/user/EpochTV (https://parler.com/#/user/EpochTV)   HELP ACU SPREAD THE WORD!  Please go to Apple Podcasts and give ACU a 5 star rating. Apple canceled us and now we are clawing our way back to the top. Don't let the Leftist win. Do it now! Thanks. Forward this show to friends. Ways to subscribe to the American Conservative University Podcast Click here to subscribe via Apple Podcasts Click here to subscribe via RSS You can also subscribe via Stitcher FM Player Podcast Addict Tune-in Podcasts Pandora Look us up on Amazon Prime …And Many Other Podcast Aggregators and sites   Please help ACU by submitting your Show ideas. Email us at americanconservativeuniversity@americanconservativeuniversity.com Please go to Apple Podcasts and give ACU a 5 star rating. Apple canceled us and now we are clawing our way back to the top. Don't let the Leftist win. Do it now! Thanks.

The Castle Report
The Worst Thing That Has Happened to Humanity

The Castle Report

Play Episode Listen Later Dec 10, 2021 12:36


Darrell Castle talks about how fear of the pandemic is being used by various people around this world to dismantle democracy, obliterate constitutional rights, and usher in totalitarian governments. Transcription / Notes THE WORST THING THAT HAS EVER HAPPENED TO HUMANITY Hello this is Darrell Castle with today's Castle Report. This is Friday the 10th day of December in the year 2021.  This report will discuss how fear of the pandemic is being used by various people around this world to dismantle democracy, obliterate constitutional rights, and usher in totalitarian governments and leaders. Before I begin I make note that last Tuesday the 7th of December, was the 80th anniversary of the attack on Pearl Harbor that launched the United States into World War ll. That date is an appropriate start from which to begin a discussion of fear and what it is currently doing to the once free people of the world. The United States had a population of about 160 million at the start of the war and during the four years of conflict about 16 million served in uniform or about 10% of the population. They served because their nation had been attacked and because evil had to be eliminated from the world. Their victory gave the world, even defeated foes, a chance at democracy or the right of people to govern themselves. Today, we find ourselves in another battle, the greatest battle of our lifetimes, possibly of all time, according to Robert F. Kennedy Jr. in his book, “The Real Anthony Fauci” which I again urge you to read. Mr. Kennedy describes how a coalition of forces—intelligence agencies, pharmaceutical companies, social media titans, medical bureaucracies, mainstream media, and the military, are using fear induced by a health crises to impose totalitarian control worldwide. Anthony Fauci is the face of this coalition, its most prominent face, because he has been medical advisor to six presidents. Mr. Kennedy argues that the concept of regulatory capture has turned U.S. public health agencies into veritable pharmaceutical companies. For example, the U.S. Food and Drug Administration (FDA) receives 45% of its annual budget from big Pharma. Big Pharma receives much of its profits from the U.S. taxpayers via vaccine payments, etc., which money is then used to fund governmental agencies responsible for regulating the industry. Fauci in his role as head of the National Institute of Allergy and Infectious Diseases (NIAID) no longer looks out for public health but instead is in the business of pharmaceutical promotion. Just a few of the facts exposed in this book would be enough, but there are more than just a few. In 1984 when Fauci took over NIAID, 11.8% of Americans had a chronic disease, and now it is 54%. It was his job to research and discover why autism, allergies and many other diseases were increasing and eliminate the toxins causing it. Instead of acting as a true public health agency he used it to develop and sell pharmaceutical products. He accomplished these things by creating a climate of fear in America and around the world that would make the world run to pharmaceuticals. These drugs were funded by U.S, taxpayers and some of the profits were then funneled back to the agencies that were charged with regulating them. So much money changed hands that it corrupted everyone it touched and the incentive to create more unfounded fear increased accordingly. Originally, it was the AIDS epidemic which was supposed to wipe out the human race. It was a disease which anyone other than IV drug users and male homosexuals had only an infinitesimally small risk of contracting, but it was used to create fear in the general population and thereby sell the drug cocktails developed to treat it. AIDS was terrible and scary but something more frightening was needed to induce the population of the world to rush to the coalition's only available preventive. A series of flus started to appear in the world usually originating in China. Swine Flu, Bird Flu,

CrossroadsET
Live Q&A: FDA Wants 75 Years to Release Pfizer Data; China's Economy Braces as Evergrande Defaults

CrossroadsET

Play Episode Listen Later Dec 10, 2021 64:48


The Food and Drug Administration (FDA) wants 75 years before it fully makes public its data on the Pfizer and BioNTech vaccines. And in other news, China's Evergrande has defaulted, and the world is now bracing for the potential economic impact. In this live Q&A with Crossroads host Joshua Philipp, we'll discuss these stories and others, and answer questions from the audience. ⭕️ Stay up-to-date with Josh with the Crossroads NEWSLETTER

The New American Podcast
FDA Claims It Needs Until 2096 to Fully Release Pfizer COVID-19 Vaccine Data

The New American Podcast

Play Episode Listen Later Dec 9, 2021 5:13


The United States Food and Drug Administration (FDA) is saying that it needs a full 75 years in order to fully release all data concerning the Pfizer and BioNTech vaccine against COVID-19. Previously, the FDA claimed it needed 55 years to release vaccine information such as safety, efficacy, test protocols, and adverse reaction reports, among other data.   Read Full Article Here!

ASCO Daily News
Spotlight on Kidney Cancer With Drs. Toni Choueiri and Sumanta "Monty" Pal

ASCO Daily News

Play Episode Listen Later Dec 9, 2021 22:52


Guest host, Dr. Neeraj Agarwal, ASCO Daily News editor-in-chief and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, discusses the practice-changing KEYNOTE-564 and SWOG 1500 trials with Drs. Toni Choueiri and Sumanta "Monty" Pal. Dr. Choueiri is director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute and Dr. Pal is co-director of City of Hope's Kidney Cancer Program and associate editor of Cancer.Net. (This episode was recorded on 11/18/2021) Transcript Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News podcast. I am Dr. Neeraj Agarwal, the director of the Genitourinary Oncology Program, and the professor of Medicine at the University of Utah Huntsman Cancer Institute, and editor-in-chief of the ASCO Daily News. I'm delighted to welcome two internationally recognized leaders in the field, Dr. Toni Choueiri and Dr. Sumanta (Monty) Pal, for a discussion about two practice-changing studies in kidney cancer published this year-- KEYNOTE-564 and SWOG 1500. As a quick introduction, Dr. Choueiri is the director of Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute. He's also the Jerome and Nancy Kohlberg Chair, and professor of medicine at the Harvard Medical School. Dr. Sumanta "Monty" Pal is a professor in oncology, and co-director of City of Hope's Kidney Cancer Program, and he is an associate editor of cancer.net of ASCO. Our full disclosures are available in the show notes. And disclosures relating to all episodes of podcasts can be found on our transcripts at ASCO.org/podcast. Toni and Monty, what a day it has been for our patients with kidney cancer. I woke up with the news of the U.S. Food and Drug Administration (FDA) approval of the first ever adjuvant immunotherapy for patients with renal cell carcinoma. It is so great to have you both on the podcast today.   Dr. Monty Pal: Glad to be here. Thanks, Neeraj.   Dr. Toni Choueiri: Thank you, Neeraj. So glad to be here.   Dr. Neeraj Agarwal: So, let me start by asking questions to you first, Toni. So, you recently published the primary results of the phase 3 KEYNOTE-564 study, showing the efficacy of adjuvant therapy with pembrolizumab and immune checkpoint inhibitor in patients with renal cell carcinoma. And this study led to the approval of pembrolizumab this morning. So, please tell us more about the study design and why did you do this study.   Dr. Toni Choueiri: Thank you, Neeraj. And thank you, really, ASCO for this wonderful podcast series. And a big hit, I always listen to them when I'm driving or jogging. And really, thanks for this opportunity because kidney cancer adjuvant therapy has been something like a holy grail we're trying to find for a long, long time. The first adjuvant trial, a randomized trial, in renal cell cancer was in 1973 with radiation therapy. And since that time, all the trials except for one have been a complete failure in a way. And the first adjuvant immunotherapy trial was with old immunotherapy cytokine that we don't use much anymore and was in 1992. I was not done with medical school. I was not actually done with high school at that time, let alone medical school. And now that we have, as we all know, a revolution in the oncology field through these immune checkpoint inhibitors that reinvented immunotherapy in cancer, and now that pembrolizumab has shown activity in patients with more advanced disease, we thought about taking this into the adjuvant setting, a setting of patients where they were subjected to surgery. But on the pathology report, we knew that their risk of this cancer coming back, of recurrence, is somewhat intermediate high or high. These are patients that have stage 2 but grade 4, stage 3, D3, D4. These are patients that had node-positive resected. And we took even patients where the kidney is out, but, also, they had a removal of a metastatic site--let's say a lung metastasis--within a year of removing the kidney. And we know these patients we refer to as M1NED are at quite high risk of recurrence. And we randomly assigned 994 patients to receive pembrolizumab for a year versus placebo. And after a median follow-up of only 2 years--so I want to insist here that this is short for any trial in general--we saw a decrease in the risk of recurrence or death. The hazard ratio for disease-free survival was 0.68. So, a 32% decrease in the risk of recurrence or death. We looked at safety, and we already are familiar in the field of GU oncology with pembrolizumab. And we didn't see when we looked at the safety profile any surprises, any enhanced toxicity. Of course, immune-related adverse events are the number one concern with pembrolizumab. There were no deaths on trial related to pembrolizumab. We saw around 7% of patients needing high dose steroid to medicate these immune-related adverse event, and some patients had to come off therapy for that. We also took a look, Neeraj, an early look, at overall survival. We only had 25% of events, 51 deaths. And we did not meet the very rigorous statistical significance that is needed to say that study is positive for overall survival. But the hazard ratio was 0.54, a 46% decrease in the risk of death, which is kind of encouraging. And after a year, the curve starts to separate. Before a year, they're not separating. And that is consistent with prior studies in general.   Dr. Neeraj Agarwal: This is a very interesting point you just raised, that DFS, disease-free survival, is strongly positive. And even overall survival is trending in the right direction, right?   Dr. Toni Choueiri: Correct.   Dr. Neeraj Agarwal: That's great. So obviously, I would like to raise another point here. When we talk about adjuvant study, we usually think about a localized kidney cancer, which is removed by the surgeon, and then [the] patient is coming to see us for treatment in adjuvant setting. But this study, I would like to highlight, as you said, also included patients who had oligometastatic disease, had successful surgical removal of the oligometastatic disease, and they were also eligible for this trial.   Dr. Toni Choueiri: Yes, absolutely. And I think this is somewhat on the recent side in clinical trials in kidney cancer. The reason for that is that, in practice, we see those patients. And we even had two small trials in the TKI era with sorafenib and pazopanib, small studies, were also completely negative. So, we thought here that we should not exclude these patients. They end up being 6%, 7% of all participants, but this remains an area of unmet medical need.   Dr. Neeraj Agarwal: So, how is the hazard ratio in those patients who had metastatic disease removed and then treated with pembrolizumab?   Dr. Toni Choueiri: Yeah, it was very low. It was 0.2, so 0.29. And this was great to see. I don't want to go into really over-interpreting these results. All the hazard ratio--when you look at subgroup analysis or in the forest plot, all the hazard ratio are less than 1. We didn't see something--let's say 1.5--in favor of pembrolizumab. Now you go into a smaller subgroup, then your confidence intervals are very large and hard to interpret, except that to say, look, on average there could be a significant benefit here, but we can't tell.   Dr. Neeraj Agarwal: Sure, absolutely. I agree with you. So, how this is going to affect the current treatment paradigm, which is for patients with newly diagnosed metastatic RCC, where combination of VEGF-TKI plus immunotherapies (IOs) or IO/IO combinations have become standard of care or treatment paradigm?   Dr. Toni Choueiri: I do believe it will be a standard of care currently in the right population. There are a lot of unanswered questions, but that will be answered hopefully with more follow up. We have already, beside these results, reported--so these results were reported in the plenary session at the 2021 ASCO [Annual Meeting]. But later on, another analysis dealing with patient-reported outcome and quality of life was reported at ESMO and also showed no detriment in quality of life--that's the voice of the patient--no detriment with pembrolizumab (pembro). There is a lot still to do and a lot of unanswered questions, such as the non-clear cell histology, those patients who had surgery of their metastatic disease more than a year. But most important, I think, two questions. One, how can you know from the get-go who are the patients that need adjuvant pembrolizumab? We do not have any valid ctDNA. And I know Dr. Pal was involved with a lot of these type of research. We don't have any ctDNA test that is really that faithful and sensitive in the MRD space in renal cell. Many of us are working, so we don't know. We may end up over-treating patients that need surgery only. And actually, we may end up under-treating patients that need, perhaps, pembro, and another drug. And the second thing in those patients--and I hope it does not happen, but unfortunately, it will to some extent--whose tumor progress on adjuvant pembrolizumab, what do you do? What's the treatment paradigm? And actually, there is no data. This is a data-free zone. And I would think somebody whose tumor progressed, tumor continued to grow or grows, while they're actively on pembrolizumab, on IO, is way different than someone whose tumor comes back after 2 or 3 years from stopping the drug. Should we treat them with the same drug? Should we treat them with the TKI plus IO? Luckily, there are trials that are ongoing in patients whose tumor progressed after PD-1/PD-L1 inhibitor to give them a TKI as a control arm, or a TKI plus an immune checkpoint inhibitor. And I know Dr. Pal is very heavily involved with such trials. So, hopefully, we will answer this question, but not anytime soon.   Dr. Neeraj Agarwal: Very interesting, and definitely new results are posing new challenges in how we practice medicine here in the coming future. So, Monty, you are leading a trial with a very similar trial with atezolizumab. And I'm really hoping, we are all really hoping, that we see the other trial being positive, so we have more treatment options for our patients.   Dr. Monty Pal: I couldn't agree with you more. I mean, I definitely think that Toni's study really adds a lot of fuel to the fire suggesting that this strategy of adjuvant immunotherapy may be successful in localized renal cell.   Dr. Neeraj Agarwal: And I'm not going to really delve into the side effects of pembrolizumab and atezolizumab because these drugs are used quite often. They are in widespread use for different types of cancer. But just a quick question, any safety signal, Toni? Did you see any safety signal with pembrolizumab in this patient population?   Dr. Toni Choueiri: Yeah, this is an excellent question. So, nothing that would be different than using pembrolizumab overall knowing in other diseases as a single agent. So, this drug not first in human, as you know, and it's been approved in combination or as a single agent in many diseases. A tumor that the three of us treat is bladder cancer, and we know from another study how to use pembrolizumab. I think that the use of corticosteroid is somewhat of an objective way, at least to me, in looking at immune-related adverse event. And it has been between 5% to 10%, so we're not way off here. But there is no doubt that there are patients that we had no death on trial attributed to drug that may have, with pembrolizumab, some serious toxicities. We had patients that had autoimmune diabetes, hypophysitis, pneumonitis--quite uncommon, but not impossible.   Dr. Neeraj Agarwal: We'll still need to keep an eye for that, basically.   Dr. Toni Choueiri: No doubt.   Dr. Neeraj Agarwal: Yes. So, changing gears, let's talk to you, Monty. You recently presented the primary results of the SWOG 1500 trial in patients with metastatic non-clear cell renal cell carcinoma. Could you please tell us why you did this study and how this study's design was unique compared to similar studies in this setting?   Dr. Monty Pal: Yeah. No, absolutely. Toni did a great job of outlining areas that are sort of free of data in the adjuvant space, particularly with immunotherapy. I think that data-free area for us in kidney cancer for a long time has been non-clear cell histology. We just don't really know how to treat them. And I actually got advice from Toni when I was devising SWOG 1500. We planned it out as a very simple study comparing sunitinib and cabozantinib. And Toni will remember this history well. It sort of went through several iterations. The study blossomed into a six-arm trial. Ultimately, it turned into a four-arm study, looking at sunitinib versus cabozantinib versus two other MET inhibitors--savolitinib and crizotinib. And ultimately, the study was boiled down to essentially what we'd originally proposed. Two of the MET inhibitors--savolitinib and crizotinib--failed to surpass that initial analysis for PFS. So, ultimately, we demonstrated a superiority with cabozantinib over sunitinib for progression-free survival.   Dr. Neeraj Agarwal: So, what is the current treatment paradigm for patients who have newly diagnosed metastatic papillary RCC now?   Dr. Monty Pal: I think for patients who don't have genomic selection, I think that cabozantinib remains the standard. I really want to champion- and maybe Toni can talk a little bit more about this--a study that Toni is leading called the SAMETA trial, which I think has a really innovative design. And it's going to be genomically characterizing patients and randomizing to savolitinib with durvalumab or sunitinib. Tell me, Toni, if I have the design right there.   Dr. Toni Choueiri: Yes. Actually, this is a specific study in a specific population. It's not in papillary RCC as much as in those 30%, 40% of papillary RCC that have MET-driven tumors, so MET alteration, whether through chromosome 7 duplication, through chromosome 7 trisomy, through mutation or amplification. These patients will get either control arm or they will get savolitinib, which is a pure MET inhibitor that is devoid of VEGF-related toxicities, savolitinib plus durvalumab, or durvalumab alone. So, two experimental arms and one control. And the reason for this is we saw activity and quite a good toxicity profile with savolitinib, a pure MET inhibitor, over sunitinib in an earlier trial that was sunitinib against savolitinib in selected patient populations. The study had to close early. So, despite the numerical difference, this was not statistically significant. And then in another study led by Dr. Powles and colleagues, there was also some interesting activity how durvalumab could augment that activity. So, we're launching a phase 3 trial with three arms that you described very well.   Dr. Neeraj Agarwal: That's wonderful. So, what are the next steps, Monty? I mean, this is amazing to see you designing an investigator-initiated trial. This was your concept. You designed it. You built this to be a huge multicenter trial, which was open across the country, funded by the National Cancer Institute. And congratulations for making that happen. It's rare for us to see these trials going from a concept stage to a national trial, and then changing the standard of care. So, what are the next steps now for you and your team in SWOG for papillary RCC or metastatic papillary RCC? How do you build out further with the backbone of cabozantinib?   Dr. Monty Pal: I really appreciate the question, Neeraj. It's so critical to understand that we're just not quite done yet. Toni's study, as I've mentioned, is incredibly innovative. I'm also really thrilled to be working with someone who you've mentored so well, Ben Maughan, at the Huntsman Cancer Institute in Utah. And he's actually designed a brilliant study, which we're going to be leading together, which looks at cabozantinib with or without atezolizumab. Recently, in a study that you and I and Toni were a part of that we just published in JCO, we actually saw quite impressive response rates with the combination of cabozantinib and atezolizumab in patients with papillary RCC, around 47%. Those response rates were actually replicated in a separate study run by Joe Lee at Memorial Sloan Kettering. In the context of papillary disease response rates were again above a threshold of around 40%. So, I think there's something to it. But until we really subject this to randomization, I think we're not going to know whether or not cabo plus IO is standard. So, I encourage everyone to consider Toni's study. I encourage everyone to look out for our trial of cabo plus or minus atezo, which should be rolling out next year.   Dr. Neeraj Agarwal: What is the name of the trial, or the number, for our audience?   Dr. Monty Pal: Yeah, we lucked out with another great number. We got 1500 for the first trial. This is going to be SWOG 2200. So SWOG 2200, and I think it's due to open maybe in the first quarter of 2022.   Dr. Neeraj Agarwal: That's fantastic news. Any new signal? We know cabozantinib is already approved for our patients with metastatic RCC, courtesy METEOR trial led by Dr. Choueiri. Toni, it's amazing to see how many times you have changed standard of care for our patients with metastatic RCC. So, any new safety signal of cabozantinib in this patient population with metastatic papillary RCC?   Dr. Monty Pal: Nothing that appreciated. The toxicity profile was pretty much on par with what you'd anticipate for cabozantinib in the setting. Major side effects were hypertension, hand-foot syndrome, [and] diarrhea. Nothing that really sort of stood out relative to what we would expect in a clear cell population of patients.   Dr. Neeraj Agarwal: That's great. Any final messages for our patients, for our audience, for our listeners?   Dr. Toni Choueiri: Well, let me start, and maybe Monty can add. It's been, and it hopefully will continue to be, this humbling experience, where median survival from metastatic RCC in mid-2000--not long time ago during our training--has been 1 year. And now in metastatic disease, it's 4 to 5 years. And that is only going to get better. And then it's even more humbling to be in a time where you can talk about adjuvant treatment in this disease, renal cell cancer, that continues every year to kill, unfortunately, 14,000 Americans. That's just in the U.S. alone. So, we have to continue in getting more targets, more drugs, more reasonable combination, and the right patient, whether through specific biomarker that are tissue or blood-based or specific liquid biopsies that can tell you who has and who doesn't have cancer at the microscopic levels.   Dr. Neeraj Agarwal: Thank you. How about you, Monty? Any final message for our audience?   Dr. Monty Pal: I couldn't have summarized it better than Toni, just such a wonderful statement around optimism for what we've achieved so far and what's yet to come. And if I could emphasize to anyone in the audience today the need to keep progressing the field further with clinical trials, I think that would be my underlying message.   Dr. Neeraj Agarwal: Thank you again, Toni, Monty, for your valuable insights and thoughts. Thank you for all the inspiration. This is indeed so inspiring to see your work, which is changing the lives of our patients on a daily basis. Our listeners will find links to your studies in the transcript of this episode. I wish you all the best.   Dr. Toni Choueiri: Thank you.   Dr. Neeraj Agarwal: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thank you so much.   Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Pfizer, Merck    , Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Foundation Medicine, Gilead Sciences Research Funding (inst.): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas   Dr. Sumanta (Monty) Pal: Consulting or Advisory Role: F. Hoffmann LaRoche, F. Hoffman Research Funding (inst.): Eisai, Genentech, Roche, Exelixis, Pfizer Travel, Accommodations, Expenses: Genentech, Seattle Genetics   Dr. Toni Choueiri: Employment: Dana Farber Cancer Hospital Leadership: Dana Farber Cancer Hospital, NCCN, KidneyCan, ASCO, ESMO Stock and Other Ownership Interests: Pionyr, TEMPEST Honoraria: NCCN, UpToDate, Michael J. Hennessy Associates, ASCO, Harborside Press, Analysis Group,                AstraZeneca, Alexion Pharmaceuticals, Sanofi/Aventis, Bayer, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Merck          , Novartis, Peloton Therapeutics , Pfizer, Corvus Pharmaceuticals, Ipsen,                 Foundation Medicine, Eisai, PlatformQ Health, Clinical Care Options, Navinata Healthcare, Kidney Cancer Journal, Exelixis, Prometheus, Lpath, NEJM, Lancet Oncology, Cerulean Pharma, alligent, EMD Serono, HERON, Lilly, Janssen Oncology, IQvia, Aveo, and NCI. Consulting or Advisory Role: Pfizer, Bayer, Novartis, GlaxoSmithKline, Merck, Bristol-Myers Squibb, Roche/Genentech, Eisai, Foundation Medicine, Cerulean Pharma, AstraZeneca, Exelixis, Prometheus Laboratories, alligent, Ipsen, Corvus Pharmaceuticals, Lpath, Alexion Pharmaceuticals, Sanofi/Aventis, Peloton Therapeutics, UpToDate, NCCN, Michael J. Hennessy Associates, Analysis Group, Kidney Cancer Journal, Clinical Care Options, Paltform Q, Navinata Healthcare, Harborside Press, ASCO, NEJM, Lancet Oncology, EMD Serono, HERON, Lilly, ESMO, NiKang Therapeutics, Kanaph Therapeutics, Infinity Pharmaceuticals, and Aravive Research Funding (inst.): Pfizer, Novartis, Merck, Exelixis               , TRACON Pharma, GlaxoSmithKline, Bristol-Myers Squibb, AstraZeneca, Peloton Therapeutics, Roche/Genentech, Celldex, Agensys, Eisai, Takeda, Prometheus, Ipsen, Corvus Pharmaceuticals, Cerulean Pharma, Seattle Genetics/Astellas, Bayer, Foundation Medicine, Roche, Calithera Biosciences, Analysis Group, NCI, GATEWAY for Cancer Research, and Congressionally Directed Medical Research Programs (DOD) Patents, Royalties, Other Intellectual Property (inst.): International Patent Application No. PCT/US2018/058430, entitled “Biomarkers of Clinical Response and Benefit to Immune Checkpoint Inhibitor Therapy, International Patent Application No. PCT/US2018/12209, entitled “PBRM1 Biomarkers Predictive of Anti-Immune Checkpoint Response Patents, Royalties, Other Intellectual Property: ctDNA technologies Travel, Accommodations, Expenses: Pfizer, Bayer, Novartis, GlaxoSmithKline, Merck, Bristol-Myers Squibb, Roche/Genentech, Eisai, Foundation Medicine, Cerulean Pharma, AstraZeneca, Exelixis, Prometheus, alligent, Ipsen, Corvus Pharmaceuticals, Lpath, Alexion Pharmaceuticals, Sanofi/Aventis, UpToDate, Peloton Therapeutics, NCCN, Michael J. Hennessy Associates, Analysis Group, Kidney Cancer Journal, Clinical Care Options, PlatformQ Health, Harborside Press, Navinata Healthcare, NEJM, Lancet Oncology, EMD Serono, HERON, Lilly, and ESMO Other Relationship: Medical writing and editorial assistance support may have been funded by Communications companies funded by pharmaceutical companies such as ClinicalThinking, Health Interactions, Envision Pharma Group, Fishawack Group of Companies, Parexel   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.    

American Thought Leaders
Dr. Harvey Risch: Hydroxychloroquine, Ivermectin, and Other Therapeutics Highly Effective in Early COVID Treatment

American Thought Leaders

Play Episode Listen Later Dec 2, 2021 60:33


“These drugs have been suppressed… for reasons that have nothing to do with the science and the medicine.” In this episode, we sit down with Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health and Yale School of Medicine. He says therapeutics, including https://www.theepochtimes.com/t-hydroxychloroquine (hydroxychloroquine) and ivermectin, can be highly effective against COVID when they are deployed early on and in combination with different medications. In the interview, Dr. Risch criticized the U.S. Food and Drug Administration (FDA) for warning against hydroxychloroquine and chloroquine use to treat COVID-19 and revoking the emergency use authorization (EUA) for hydroxychloroquine and chloroquine. The FDA told The Epoch Times in an email that the FDA made this decision after https://www.fda.gov/media/138945/download (testing) the efficacy of hydroxychloroquine for treating COVID-19, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/MemorandumDecliningRequestforHCQEUA_081020.pdf (including) in patients in an outpatient setting. But Dr. Harvey Risch argues that outpatient reports are exceedingly few because the medication is extremely safe and the emergency use authorization in March 2020 blocked outpatient use, and he believes the FDA has conflated heart rhythm problems from severe COVID infection with adverse effects from hydroxychloroquine use in hospitalized patients. Subscribe to the American Thought Leaders https://ept.ms/ATLnewsletter (newsletter) so you never miss an episode. Follow http://epochtv.com/ (EpochTV) on social media: Facebook: https://www.facebook.com/EpochTVus (https://www.facebook.com/EpochTVus) Twitter: https://twitter.com/EpochTVus (https://twitter.com/EpochTVus) Rumble: https://rumble.com/c/EpochTV (https://rumble.com/c/EpochTV) Gettr: https://gettr.com/user/epochtv (https://gettr.com/user/epochtv) Gab: https://gab.com/EpochTV (https://gab.com/EpochTV) Telegram: https://t.me/EpochTV (https://t.me/EpochTV) Parler: https://parler.com/#/user/EpochTV (https://parler.com/#/user/EpochTV)

The Scalpel With Dr. Keith Rose
Ep.206 Thanksgiving 2021: Thankful and Vigilant

The Scalpel With Dr. Keith Rose

Play Episode Listen Later Nov 24, 2021 26:02


Ep.206 Thanksgiving 2021: Thankful and Vigilant   We at The Scalpel wish a Happy Thanksgiving for you and your family.   In this episode of The Scalpel, Dr. Rose is grateful and reflective. He also encourages us to be vigilant - to keep watch over our freedom and the tools we have available to us to keep that freedom.   https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance   The FDA budget for FY 2019 is $5.9 billion.   About 55 percent, or $3.2 billion, of FDA's budget is provided by federal budget authorization. The remaining 45 percent, or $2.7 billion, is paid for by industry user fees.   The FDA budget is equivalent to $9.95 per American per year.   The FDA budget includes 17,686 full time equivalents (FTEs).   https://childrenshealthdefense.org/defender/fda-nearly-half-funding-companies-it-regulates/   The Food and Drug Administration (FDA) has moved from an entirely taxpayer-funded entity to one increasingly funded by user fees paid by manufacturers that are being regulated. Today, close to 45% of its budget comes from these user fees that companies pay when they apply for approval of a medical device or drug.     https://youtu.be/OnId2rQYS6M   White House Energy Secretary Jennifer Granholm responds to a press conference question regarding the release of 50 million barrels of oil from the Strategic Petroleum Reserve   “...how many barrels of oil do U.S. consumers use every day?”   CONTACT THE SHOW Website: https://scalpeledge.com Email: KFR@scalpeledge.com Twitter: @TheScalpelEdge Instagram: @TheScalpelPodcast   #TheScalpel

Bobby Eberle -- 13-Minute News Hour
Transparency? Biden‘s FDA Asks for 55 Years to Release Covid Vaccine Data | Bobby Eberle Ep. 435

Bobby Eberle -- 13-Minute News Hour

Play Episode Listen Later Nov 22, 2021 16:32


Joe Biden's Food and Drug Administration (FDA) is asking a federal judge to allow the FDA to take up to 55 years to release data on the safety and efficacy of Pfizer's Covid-19 vaccine.  It only took 108 days for Pfizer to submit the documents.  Now the FDA wants 55 years to release the same information to the public?  How's that for transparency? As Joe Biden continues to push vaccine mandates, the American people are certainly entitled to the FDA's approval report and data.  Americans shouldn't have to wait until 2076 to get it. #BobbyEberle #FDA55Years #VaccineMandate

On n'est pas obligé d'être d'accord - Sophie Durocher

Entrevue avec Karl Blackburn, Président et Chef de la direction du Conseil du patronat du Québec. Le manque criant de main-d'œuvre ne cesse de croître : quelles sont les solutions à long terme ? Le ministre du travail, Jean Boulet, prévoit un «creux historique» de travailleurs en 2030.  Entrevue avec Jasmin Roy, comédien et animateur.  Le comédien a lancé un guide de «socialisation dynamique» pour aider les ados et les préados à mieux identifier leurs émotions et à recommencer à tisser des liens dans le but de lutter contre l'anxiété. Entrevue avec Josianne Desjardins, journaliste indépendante basée au Mexique. La fusillade qui a récemment causé la mort de deux narcotrafiquants sur une plage touristique au Mexique freine l'enthousiasme de plusieurs touristes à voyager vers cette destination soleil. Entrevue avec Dr Richard Béliveau, docteur en biochimie et chroniqueur au Journal de Montréal.  Une nouvelle avancée prometteuse qui serait peut-être un remède contre le cancer. Après 35 ans passés en oncologie, le Dr dit voit des résultats pour la première fois. Le projet auquel il participe a reçu l'approbation de la Food and Drug Administration (FDA) « ce qui est rare et remarquable ». Pour de l'information concernant l'utilisation de vos données personnelles - https://omnystudio.com/policies/listener/fr

On n'est pas obligé d'être d'accord - Sophie Durocher
Pour le guérir, on va offrir un cadeau empoisonné au cancer, raconte Dr Richard Béliveau

On n'est pas obligé d'être d'accord - Sophie Durocher

Play Episode Listen Later Nov 22, 2021 13:40


Entrevue avec Dr Richard Béliveau, docteur en biochimie et chroniqueur au Journal de Montréal.  Une nouvelle avancée prometteuse qui serait peut-être un remède contre le cancer. Après 35 ans passés en oncologie, le Dr dit voit des résultats pour la première fois. Le projet auquel il participe a reçu l'approbation de la Food and Drug Administration (FDA) « ce qui est rare et remarquable ». Pour de l'information concernant l'utilisation de vos données personnelles - https://omnystudio.com/policies/listener/fr

Today's Focus of Attention
US FDA approves Pfizer and Moderna as vaccine boosters for all adults

Today's Focus of Attention

Play Episode Listen Later Nov 19, 2021 1:15


The US Food and Drug Administration FDA approved this Friday Pfizer and Moderna vaccines as booster shots for all adults. This move expands the previous approval for elderly and those at high risk. Under this scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend.

Rio Bravo qWeek
Episode 75 - Multisystem Inflammatory Syndrome

Rio Bravo qWeek

Play Episode Listen Later Nov 19, 2021 36:15


Episode 75: Multisystem Inflammatory Syndrome in Children (MIS-C).  Dr Schlaerth explains the signs, symptoms, and basic management of MIS-C. Lam explain the role of anti-obesity medications in weight management. Introduction: The Role of Drugs in Weight Loss Management    By Lam Chau, MS3, Ross University School of Medicine     Today about 70% of adult Americans are overweight or obese. Obesity is associated with increased risk of heart disease, stroke, and diabetes, among many other diseases. Studies have shown losing 5-10% of your body weight can substantially reduce your risk of cardiovascular disease.  Traditional belief is that weight loss can only be attributed to diet and exercise. While there are certainly elements of truth to that statement, medication is a safe and proven method for weight management that is often overlooked. The fact of the matter is that weight loss is an ongoing field of study with constant new research and innovations.  In June of this year, a medication named Wegovy was approved for weight loss management by the FDA. This drug is indicated for chronic weight management in patients with a BMI of 27 or greater with an accompanying weight-related ailment or in a patient with a BMI of 30 or greater. Rachel Batterham, PhD, of the Centre for Obesity Research at University College London, shared: "The findings of this study represent a major breakthrough for improving the health of people with obesity. No other drug has come close to producing this level of weight loss — this really is a game changer.” Despite breakthroughs like these, the use of medication for weight loss is still relatively low. Dr. Erin Bohula, a cardiologist and assistant professor at Harvard Medical School, believes “there are probably a few reasons for this, including cost, if not covered by insurance, and a perception these agents are not safe in light of the history with weight loss agents.” A study from 2019 examined the medical records from eight geographically dispersed healthcare organizations. They found that out of 2.2 million patients who were eligible for weight loss medication, only 1.3% filled at least 1 prescription. Weight loss is a dynamic process with many different variables. While it may not necessarily be for everyone, medication can help tremendously and is an option you should consider if you are interested in weight loss[1,2]. This is Rio Bravo qWeek, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California. Our program is affiliated with UCLA, and it's sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home.  ___________________________Multisystem Inflammatory Syndrome in Children (MIS-C).   By Katherine Schlaerth, MD, and Hector Arreaza, MD. History and epidemiologyMost children who get COVID-19 have either no symptoms or very mild symptoms. However, about 18 months ago, a new pediatric complication of COVID-19, possibly postinfectious, was described.  The eight children who were initially described had a clinical presentation which was similar to either Kawasaki Disease or perhaps toxic shock syndrome, and since these children had signs of a hyperinflammatory state coupled with shock, the new syndrome was named Multisystem Inflammatory Syndrome in Children, or MIS-C for short. By midsummer of 2021, the United States had about two thousand cases and 30 deaths in children under 21.  Other name for this condition is Pediatric Hyperinflammatory Shock. DiagnosisWhat are the criteria for a diagnosis of Multisystem Inflammatory Syndrome? They include:Age below 21Fever above 100.4 degrees Fahrenheit or 38 degrees centigrade for 24 hours (a subjective fever for more than 24 hours counts too). Laboratory evidence of inflammation which should include at least two of the following tests: elevated CRP, elevated ESR, elevated fibrinogen level, procalcitonin, D-dimer, ferritin, lactic acid dehydrogenase (LDH), interleukin-6, and neutrophil counts, low lymphocyte count and low albumin.Severe disease necessitating hospitalization with multisystem organs affected. The systems affected include cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic, and neurologic (at least three systems need to be involved). No creditable other diagnosis. Other symptoms include:GI complaints (diarrhea, vomiting, abdominal pain)Skin rashConjunctivitisHeadacheLethargyConfusionRespiratory distressSore throatMyalgiasSwollen hands/feetLymphadenopathyCardiac signs and symptoms include troponin/BNP elevation and arrhythmia. Findings on ECHO may include depressed LVEF, coronary artery abnormalities, including dilation or aneurysm, mitral regurgitation, and pericardial effusion. There also must be a positive test for SARS-CoV-2 and this test can be either a reverse transcriptase polymerase chain reaction (RT-PCR), serologic, or antigen testing. Exposure to someone who has had or is suspected of having had COVID-19 within the last 4 weeks also counts.  Patients with MIS-C may have predominately gastrointestinal symptoms, mucocutaneous findings, and may be hypotensive or “shocky” on presentation. Up to 80% require ICU admission. Thrombocytopenia and /or elevated transaminase levels can also be seen.  MIS-C vs Kawasaki DiseaseThe big issue in diagnosing MIS-C is the overlap with Kawasaki's disease and with toxic shock syndrome. Patients with Kawasaki Disease in their second week of illness often will have thrombosis, not thrombocytopenia. Whereas MIS-C usually affects school age children or adolescents, Kawasaki Disease is more commonly a problem in younger children, who have an average age of 2 years.  Kawasaki Disease is also more common in Asian children and MIS-C disproportionately seems to affect Black and Hispanic children.  Obesity seems to be another risk factor for MIS-C.  Kawasaki's Disease also has different cardiac manifestations from MIS-C. Coronary artery dilatation is common in Kawasaki's disease and left ventricular dysfunction in MIS-C, although sometimes coronary artery dilatation and rarely aneurisms can be noted on echocardiogram in putative MIS-C, which is why differentiation from Kawasaki's Disease is an issue.  PathophysiologyThe cause of MIS-C is probably postinfectious immune dysregulation. Only a minority of MIS-C patients are identified as having COVID-19 by RT-PCR, but most have positive tests for immunoglobulin G.  Statistically, there is a lag of 4-6 weeks between peak community cases of COVID-19 and the time at which children present with MIS-C.   Although research is being done on MIS-C, and theories abound about etiology, there is no clear-cut answer to why some children get MIS-C and the vast majority do not. In a review of the literature on MIS-C using literature from December 2019 through May 2020, gastrointestinal symptoms such as diarrhea, and abdominal pain were 4-5 times more common than cough and respiratory distress.  There was a slight preponderance of male patients and mean age was 8 ½ years. ICU admission was common and 2/3 required inotropic support, over ¼ needed respiratory help with extracorporeal membrane oxygenation warranted in 31 children. The death rate was 1.5 % of these very sick children treated in hospital.  In another smaller study, 80% had mild, but 44% had moderate to severe EKG abnormalities including coronary involvement. The good news was that coronary arteries were normal in all children after a month, and at 4-9 months, only 2-4% had mild heart abnormalities. Unfortunately, mechanisms of MIS-C as well as universal treatment is still being worked out. Published articles may be delayed due to time constraints in publishing. Other immunologic interventions do not have sufficient data. TreatmentWhat about the treatment of children diagnosed with MIS-C?Usually, a variety of specialists become involved initially. These can include pediatric rheumatology, infectious disease, cardiology, and hematology. If children with MIS-C meet criteria for complete or incomplete Kawasaki disease as well, regardless of COVID-19 testing results, IVIG and aspirin are reasonable.  Corticosteroid use must be individualized, and if used it may require a taper.  An echocardiogram can be done initially looking for coronary aneurisms and repeated in a week.  In severe cases, shock may be a presenting factor needing urgent attention. Generally, the treatments used are decided by the aforementioned consults and may consist of immunomodulating therapy, including possibly IVIG (2g/kg), and/or corticosteroids methylprednisolone (30mg/kg).  AntiviralsThe role of antiviral therapy is unclear and remdesivir should be reserved for children with acute COVID-19.  COVID-19 vaccination-associated myocarditisAnother entity which needs further evaluation is COVID-19 vaccination-associated myocarditis in adolescents. This problem is more common in young males and may occur after the administration of mRNA based COVID-19 vaccines. The presentation occurs within 2 weeks of COVID-19 vaccination, and clinical presentation can include chest pressure, abnormal biomarkers (elevated troponins), and cardiac imaging findings. It is unknown if subclinical cases occur.  COVID-19 infection in children, while usually benign, has the potential to become serious, and the association between some mRNA vaccines and the occurrence of myocarditis has yet to be thoroughly studied. We look forward to more and better data to guide the care of children and young adults in these spheres. The risk of having myocarditis is still higher with the actual COVID-19 than the COVID-19 vaccine. The incidence of myocarditis after BioNtech/Pfizer vaccine was 2.13 cases per 100,000 persons in a large study done in a large health care organization in Israel where more than 2 million people were vaccinated (that represents 0.00213%). Another US study showed that there were 77 cases per million doses of vaccines in young male, in contrast, there were 450 cases of myocarditis per million COVID-19 cases in the same age group.____________________________Conclusion: Now we conclude our episode number 74 “Multisystem Inflammatory Syndrome in Children.” Dr. Schlaerth explained that MIS-C is a work in progress in terms of pathophysiology, diagnosis, treatment, and prognosis. MIS-C and Kawasaki Disease are very similar, but, for example, GI symptoms, cardiac dysfunction, shock and multisystem dysfunction are more prominent in MIS-C than Kawasaki Disease. Whereas coronary artery aneurysms are more common in Kawasaki disease than MIS-C. Even without trying, every night you go to bed being a little wiser.Thanks for listening to Rio Bravo qWeek. If you have any feedback about this podcast, contact us by email RioBravoqWeek@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. This podcast was created with educational purposes only. Visit your primary care physician for additional medical advice. This week we thank Hector Arreaza, Katherine Schlaerth, and Lam Chau. Audio edition: Suraj Amrutia. See you next week! _____________________References:FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014, June 04, 2021, U.S. Food and Drug Administration (FDA), https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014. Saxon DR, Iwamoto SJ, Mettenbrink CJ, et al. Antiobesity Medication Use in 2.2 Million Adults Across Eight Large Health Care Organizations: 2009-2015. Obesity (Silver Spring). 2019;27(12):1975-1981. doi:10.1002/oby.22581. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6868321/.  Carroll, Linda, Weight-loss pills can help. So why don't more people use them? NBC News Health Care, September 2, 2018.  https://www.nbcnews.com/health/health-care/weight-loss-pills-can-help-so-why-don-t-more-n905211 World Health Organization, WHO recommends groundbreaking malaria vaccine for children at risk, October 6, 2021. https://www.who.int/news/item/06-10-2021-who-recommends-groundbreaking-malaria-vaccine-for-children-at-risk Lee, Min-Sheng et. al, Similarities and Differences Between COVID-19-Related Multisystem Inflammatory Syndrome in Children and Kawasaki Disease, Front. Pediatr., 18 June 2021, https://doi.org/10.3389/fped.2021.640118.  Gail F. Shust, Vijaya L. Soma, Philip Kahn and Adam J. Ratner, Pediatrics in Review July 2021, 42 (7) 399-401; DOI: https://doi.org/10.1542/pir.2020-004770. Jain SS, Steele JM, Fonseca B, et al. COVID-19 vaccination-associated myocarditis in adolescents. Pediatrics. 2021; doi:10.1542/peds.2021-053427.  https://pediatrics.aappublications.org/content/pediatrics/early/2021/08/12/peds.2021-053427.full.pdf.  Wilson, Clare, Myocarditis is more common after covid-19 infection than vaccination,  New Scientist, 4 August 2021, https://www.newscientist.com/article/mg25133462-800-myocarditis-is-more-common-after-covid-19-infection-than-vaccination/#ixzz79JPn2E47. Son, Mary Beth F, MD, and Kevin Friedman, MD, COVID-19: Multisystem inflammatory syndrome in children (MIS-C) clinical features, evaluation, and diagnosis, Up to Date, September 2021, https://www.uptodate.com/contents/covid-19-multisystem-inflammatory-syndrome-in-children-mis-c-clinical-features-evaluation-and-diagnosis?search=kawasaki%20vs%20misc&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1  

CrossroadsET
Live Q&A: OSHA Suspends Biden Vaccine Mandate; FDA Wants 55 Years to Release Vaccine Approval Data

CrossroadsET

Play Episode Listen Later Nov 19, 2021 67:34


The Labor Department's Occupational Safety and Health Administration (OSHA) announced it has suspended the Biden vaccine mandate for COVID-19 in both implementation and enforcement for businesses with 100 or more employees. And in other news, the Food and Drug Administration (FDA) is asking a court for 55 years to release information on its approval for the Pfizer-BioNTech COVID-19 vaccine. In this live Q&A with Crossroads host Joshua Philipp, we'll discuss these stories and others, and answer questions from the audience. ⭕️ Stay up-to-date with Josh with the Crossroads NEWSLETTER

News & Features | NET Radio
UNMC Leading International Study for COVID-19 Pill

News & Features | NET Radio

Play Episode Listen Later Nov 17, 2021 1:08


Dr. Florescu said a separate study looked at the same drug and its effectiveness for outpatient care following a confirmed COVID infection. That study has good initial results and the pharmaceutical company MERCK is sending a request to the Food and Drug Administration (FDA) for emergency approval. Dr. Florescu and UNMC's study examines the pill's use for preventative care.

Daily News Brief
Daily News Brief for Wednesday, November 17, 2021

Daily News Brief

Play Episode Listen Later Nov 17, 2021 19:09


So, as most of you know, I was in Mexico last week for a family wedding, well it is good to be back in the studio, and back to the hands on the plow. Having grown up in Texas, having lived in New Mexico, it reminded me how important Mexico really is, and I would love to find good connections to build out Fight Laugh Feast Mexico, similar to what we are doing in Canada. So, if you know of any good churches or Christian leaders down in Mexico, and would love to connect them, please email me at Waterboy@CrossPolitic.com. Folks, we are already getting excited about Christmas around here. It is November, so that is allowed right? Well starting now, for all those who sign up for an annual Silver membership or above will get our CrossPolitic Christmas Man Box. This box will come with: -Special Fresca Holiday T-Shirt* -CrossPolitic Patch Hat -3 Fight Laugh Feast Cigars (Little Anthony's) -CrossPolitic Ceramic Camper Mug So, go to FightLaughFeast.com, click on Shop, and make sure you select an annual membership that is Silver or above for this offer. Included in this offer is a 13 month member, meaning we will bill you in January, CrossPolitic stickers, and a signed thank you note by the CrossPolitic crew. Get this while supplies last! Secondly, all club members will be getting a free copy of our Flight Laugh Feast Christmas magazine. I know some club members are already magazine subscribers, so if that is the case, you can just gift the magazine to your favorite friend for Christmas. Lastly ladies, we have not forgotten about you. Actually men, here is your opportunity to buy your wife a unique Christmas present. Rowdy Christian Clothing is now carrying beautiful Fight Laugh Feast bracelets that come in brass, gold, or silver. Go to RowdyChristian.com and order them while supplies last for Christmas! Liberals Don't Want Logic: Play clip: https://rumble.com/vpbc7w-the-view-hosts-cut-off-unvaxxed-conservative-guest-for-sharing-covid-facts.html?mref=22lbp&mc=56yab Texas Dem Ryan Guillen switches to Republican Party over defunding the police, 'chaos' on the border https://www.foxnews.com/politics/texas-dem-switches-republican-defunding-police-border According to Fox News: “A Texas Democrat switched his affiliation to the Republican Party over the party's left-leaning embrace of defunding the police policies and "chaos" on the southern border. State Rep. Ryan Guillen announced in a Monday press conference that he would seek reelection to his south Texas seat as a Republican, saying the Democratic Party's far-left values are no longer in line with his own. Specifically, Guillen cited his now-former party's backing of defunding the police and the compounding crisis at the southern border under President Biden. "Friends, something is happening in South Texas, and many of us are waking up to the fact that the values of those in Washington, D.C., are not our values, not the values of most Texans," Guillen said. "The ideology of defunding the police, of destroying the oil and gas industry and the chaos at our border is disastrous for those of us who live here in South Texas," he continued. The former Democrat had won his seat by nearly 17 points in the 2020 election and has served in the Texas House for almost two decades.” YouTube Cuts Off the Best Real-Time, Legal Coverage of Rittenhouse Trial and Immediately Regrets It https://pjmedia.com/news-and-politics/victoria-taft/2021/11/15/youtube-cuts-off-the-best-real-time-legal-coverage-of-rittenhouse-trial-and-immediately-regrets-it-n1533042 “The Rekieta Law channel, which featured multiple lawyers doing real-time analysis of the trial Rittenhouse trial, often beat the number of people watching the PBS stream. The PBS stream is one of the more reliable ones available to YouTube users and was being used by several outlets.” Well guess what Youtube did to them? Ya you guest, Youtube cut off their live feed as “Assistant District Attorney Thomas Binger began his closing statement”. As you know, we are still suspended from Youtube, I think, until November 22nd. Youtube is big tech, and big tech hates the truth. So any honest attempt at live streaming a fair assessment of the Rittenhouse trial, and that was competing with platforms like PBS, will get the cancel treatment. Rekieta's media team tweeted this out: Florida woman dies after unsuccessful suit to get ivermectin https://thehill.com/regulation/healthcare/581735-florida-woman-dies-after-unsuccessful-suit-to-get-ivermectin A teacher in Palm Beach Gardens, Fla., who was hospitalized with COVID-19 died following her husband's unsuccessful attempts to force doctors to treat her with the anti-parasitic drug ivermectin, according to reports from ABC News. Tamara Drock, 47, spent 12 weeks at the Palm Beach Gardens Medical Center, as explained by her husband, Ryan Drock, per ABC News. According to The Palm Beach Post, she was not vaccinated against COVID-19. Ryan Drock sued the hospital in October over its refusal to administer ivermectin to his wife, ABC News reported. Misinformation about ivermectin's ability to treat coronavirus infections has circulated widely online in recent months. However, the Food and Drug Administration (FDA) has stated that "ivermectin has not been authorized or approved for use in preventing or treating COVID-19 in humans or animals." The agency also noted that "ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea." Ryan Drock's lawsuit was rejected by Palm Beach County Circuit Judge James Nutt in October, according to ABC News's reports, as Nutt said that permitting a judge's rule to override a doctor's recommendation could set a dangerous precedent. Nutt encouraged the Drock family to try to negotiate a deal on their own with the doctors at the hospital. A doctor at the hospital did eventually agree to administer ivermectin, though the family attorney said it was too low of a dose, per ABC. QR code now the only acceptable form of COVID-19 vaccine proof in Alberta According to Canada's government media, I mean Global News: “Alberta residents will now need more than a paper record from a COVID-19 vaccine clinic if they want to sit down at a restaurant, work out at a gym or enter indoor venues like arenas or movie theatres. Albertans hoping to enter any business that has implemented the COVID-19 restrictions exemption program — or Alberta's vaccine passport — will now need to have the QR code provided by the provincial government. As of Monday, proof of vaccine received at the time of vaccination or those saved from MyHealthRecords is longer be accepted. “Alberta's more secure and scannable QR code vaccine record makes it easier for Albertans to safely take part in daily activities,” Health Minister Jason Copping said.”” UK “set to require three vaccinations from those eligible for booster”: https://www.theguardian.com/world/2021/nov/15/no-10-plans-booster-jab-requirement-for-people-to-obtain-covid-pass According to the Guardian: “Ministers are set to require three vaccinations from those eligible for booster jabs in order to qualify as being fully vaccinated in areas where people must prove their status, such as travel or avoiding mandatory isolation. Downing Street sources said the intention was to end up in a place where three jabs, rather than two, was the requirement to obtain a Covid pass showing full vaccination – though currently only over-40s are eligible for the booster. If the Joint Committee on Vaccination and Immunisation (JCVI) continues to recommend boosters for all adults six months after their second jab, then the requirement could be in place in England by the early spring. News of the plan came as England's chief medical officer, Chris Whitty, also warned there was “major concern” about vaccination rates among pregnant women – saying 98% of severely ill pregnant women in hospital had not been vaccinated. Speaking at a press conference on Monday, Boris Johnson said the concept of what constitutes “full vaccination” will need to be adjusted – and said that getting a third jab would become part of that.” Read it and Weep: California Hits All-Time High Gas Prices, and Some SoCal Stations Charge More According to NBC LA: “California just hit a new all-time record high for the average price of a gallon of regular gasoline, and some local gas stations around SoCal are charging even more. At one gas station in the Mid Wilshire district, on Monday, a gallon of regular unleaded is $5.99, while a gallon of premium gas is $6.59. California's gas prices are higher, on average, than any other state: the national price for a gallon of regular unleaded gas is $3.41. According to AAA, the statewide average price for a gallon of regular unleaded gas is $4.68 in California as of Monday. Other regions around SoCal were slightly cheaper than the average California price, but not by much: -In the Long Beach/Los Angeles area, the average price for one gallon of regular gas is $4.67, -in Orange County, the average price for one gallon of regular gas is $4.63, -in San Bernardino County, the average price is $4.61, and -in Riverside County, the average price is $4.59.” Closing This is Gabriel Rench with Crosspolitic News. Support Rowdy Christian media by joining our club at fightlaughfeast.com, downloading our App, and head to our annual Fight Laugh Feast Events. With your partnership, together we will fight outdated and compromised media, engage news and politics with the gospel, and replace lies and darkness with truth and light. Go to fightlaughfeast.com to take all these actions. Have a great day. Lord bless

Science Friday
Kids Under 12 Vaccine, Reduced Cow Methane From Seaweed Diet, Lost SciFri Theme Song. November 5, 2021, Part 2

Science Friday

Play Episode Listen Later Nov 6, 2021 47:41


Fact Check My Feed: More Kids Can Get COVID-19 Vaccines. Now What? Many parents around the U.S. breathed a sigh of relief—or an even more intense emotional reaction—at the long-awaited news that the Centers for Disease Control and Prevention (CDC) had signed off on advising the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11 this week. The recommendation came after a unanimous vote from the agency's committee of outside vaccine experts. And last week, the Food and Drug Administration (FDA) authorized the shot after a review of clinical trial data found both low risk and high efficacy in a smaller, kid-calibrated dose of the vaccine. University of Saskatchewan virologist Angela Rasmussen joins Ira to look at the data behind the FDA's long-anticipated decision. They also discuss the rationale behind booster shots for high-risk adults, what it means that deer in Iowa have been caught transmitting the virus, COVID-pragmatic holiday planning, and other pandemic news.   In First Real-World Experiment, Red Seaweed Cuts Methane In Cows By More Than Half Methane emissions are a hot topic—largely because it's a big contributor to climate change. Methane makes up about 10% of human-caused greenhouse gas emissions. 27% of that comes from the burps of ruminant animals, such as cows. In April, Science Friday did a story about research that showed promising results when steers were fed small amounts of the red algae Asparagopsis in their diets. At the time, these experiments were only done in a closely controlled university setting. Now, the first real-world study on a working dairy farm has been completed. The results? Methane released by the seaweed-eating cows was 52% less on average than their non-seaweed-munching counterparts. Coming on the heels of the Biden administration's methane emissions reduction plan, SciFri producer Kathleen Davis sits down with three key players in this milestone: Joan Salwen, CEO of Blue Ocean Barns in Kailua-Kona, Hawaii, the company that produces the Asparagopsis seaweed powder; Dr. Breanna Roque, animal science consultant at Blue Ocean Barns in Townsville, Queensland, Australia; and Albert Straus, founder and CEO of Straus Family Creamery in Marshall, California.   The Science Friday Theme Song That Got Lost In The Mail Back in 1998, comedian and author Steve Allen, first host of The Tonight Show, joined Ira on Science Friday to talk about the importance of critical thinking. Allen had written a book called Dumbth, calling for improvements in the public's logical reasoning abilities. Ira was a longtime fan of Allen's, and eagerly invited him to discuss the book. During the interview, Allen also took to the studio piano to play his signature song, “This Could Be The Start of Something Big.” As the comedian was leaving, Ira jokingly remarked that Science Friday could use a theme song of its own. Several years later, while cleaning the cluttered SciFri office, staff uncovered an unopened box of mail—including an envelope from Hollywood containing a single cassette tape, marked “Theme Song For Science Friday—Steve Allen.” As part of Science Friday's 30th anniversary celebrations, Ira and SciFri director Charles Bergquist recount the story of the tape, and finally premiere the song, written and performed by the late Steve Allen.      

Cannabis Legalization News
Can Biden Legalize Marijuana? Congressional Research Service Says President Can legalize weed

Cannabis Legalization News

Play Episode Listen Later Nov 5, 2021 5:45


Can Biden Legalize Marijuana? The Congressional Research Service Says He Can.Read about it: https://crsreports.congress.gov/product/pdf/LSB/LSB10655

Super Human Radio
Testosterone replacement in aging men: evidence-based patient-centric study

Super Human Radio

Play Episode Listen Later Nov 4, 2021 136:06


SHR # 2785:: Testosterone replacement in aging men: evidence-based patient-centric study - Daniel Bossa - The deluge of advertisements marketing erectile dysfunction medications and testosterone products has empowered many older men to seek medical help for their sexual and genitourinary problems. As a reflection of this historical transition toward increased attention on men's sexual health, men's health clinics have sprung up across the United States; concomitantly, testosterone prescription sales increased from about $100 million US dollars in the year 2000 to nearly $2.7 billion in 2013. Today, a majority of testosterone prescriptions are written for men aged 40–64 years (1) even though testosterone is not approved by the US Food and Drug Administration (FDA) for age-related decline in testosterone. Citing the lack of data on long-term benefits and risks of testosterone treatment in older men with age-related decline, the FDA has sounded alarm over the growing off-label use of testosterone. Experts have debated whether prescribing testosterone to older men with testosterone deficiency is disease mongering or whether subsets of older men with testosterone deficiency might benefit from testosterone treatment. Fortunately, several recent randomized controlled trials (RCTs) have provided important information on the efficacy and short-term safety of testosterone treatment in older men. This Viewpoint synthesizes data from epidemiologic studies and RCTs and offers a perspective on a patient-centric approach to treatment decision in older men with testosterone deficiency based on an individualized assessment of benefits and risks.

Real Talk with Zuby
#176 Dr. Martin Kulldorff - Covid-19: An Honest Perspective

Real Talk with Zuby

Play Episode Listen Later Nov 1, 2021 65:19


Dr. Martin Kulldorff is a professor of medicine at Harvard Medical School. He served on scientific advisory committees to the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). Martin specialises in epidemiology, biostatistics, and vaccine safety. He is also one of the co-authors of 'The Great Barrington Declaration' - which was critical of many of the public health policies surrounding Covid-19, including lockdowns and school closures.Follow Zuby - https://twitter.com/zubymusic Follow Martin - https://twitter.com/MartinKulldorffSubscribe to the 'Real Talk With Zuby' podcast on Apple Podcasts, Spotify & more - https://fanlink.to/zubypodcast Support Zuby on Patreon - https://patreon.com/zubymusicSpecial thanks to GOLD TIER Patreon members: Adam Patterson, Joseph Skelton, Andrea Mucelli, Matt Gallagher, Matthew Steinfeld, The Hagengnome, Divya Sholaga, Edwin Chiang, Libbie Richardson & Mondo!Website - https://zubymusic.com Online Store - https://teamzuby.com 'Strong Advice: Zuby's Guide to Fitness For Everybody' eBook - https://gumroad.com/l/zubyfitness

KBS WORLD Radio Korea 24
Korea 24 - 2021.10.21

KBS WORLD Radio Korea 24

Play Episode Listen Later Oct 21, 2021


Korea24 – 2021.10.21. (Thursday) News Briefing: President Moon Jae-in has announced that South Korea’s first domestically developed space rocket, Nuri, was successfully launched into space, but failed to put its dummy satellite into orbit. The rocket flew to its target altitude of 700 kilometers, and while it did not achieve its ultimate goal, Moon praised the “creditable achievement” made by the nation’s scientists and engineers. In-Depth News Analysis (Korean Politics Digest): Gyeonggi Province Governor and presidential candidate of the ruling Democratic Party, Lee Jae-myung, faced lawmakers during two parliamentary audit sessions this week, with questions being asked over allegations of corruption related to the Seongnam land development project. Meanwhile, the main opposition People Power Party’s leading presidential contender Yoon Seok-youl has also found himself in hot water, after he made controversial comments seemingly praising the former President Chun Doo-hwan. Meanwhile, there is speculation that the minor opposition party chief, Ahn Cheol-soo, is set to announce his bid to run for President too. Affiliate Professor Kim Byung-joo from the Hankuk University of Foreign Studies helps us look through these developments. Korea Trending with Jung Ye-won: 1. Singer and actor Jeon Hyo-seong has collaborated with Professor Seo Kyung-deok to produce a video about the traditional Korean clothing Hanbok, to celebrate Hanbok Day. (전효성·서경덕, 한국의 문화유산 ‘한복’ 세계에 알린다) 2. A heartwarming story of two neighbors who cordially dealt with apartment noise issues with handwritten letters and thoughtful gifts has been attracting attention online. ("층간 소음 죄송" 손편지에.. 아랫집 할아버지 '훈훈한 답장') 3. The U.S. Food and Drug Administration (FDA) has approved the use of COVID-19 vaccine booster shots made by Moderna and Johnson & Johnson's Janssen. (美FDA, 모더나·얀센 백신 ‘부스터샷’ 공식 승인) Explore Korea: This week, we discuss the crossover of art and architecture, with contributor Ahn Jae-woo introducing us to an online roundtable hosted by Future School, the Korean pavilion of the 2021 Venice Architecture Biennale. Jae-woo also discusses his personal project, called “Artphobia, Subjectification and Architecture.” Morning Edition Preview with Mark Wilson-Choi: - In tomorrow’s Korea Times, Kang Hyun-kyung chronicles the impact of urban redevelopment taking place in Naeson-dong, Gyeonggi Province. - In tomorrow’s Korea Herald, Kim Hae-yeon writes about author Kim Hyo-eun winning the 2021 World Illustration Awards’ Professional Children’s Publishing category for her 2016 book “I Am the Subway”, which was translated to English last year.

Pawdcast
Taming Canine Tumors with Turmeric – Teddy's Story | Episode 26

Pawdcast

Play Episode Listen Later Oct 21, 2021 37:17


In June 2013, MaryBeth Powers noticed a lump the size of a golf ball on her dog Teddy's snout.  Only two days later she heard the words no pet owner wants to hear, it was cancer.​Teddy had a sarcoma (a malignant tumor of connective or other nonepithelial tissue). The vet's orders were to “keep him comfortable, he had only about two, maybe four weeks to live”.   As Marybeth recounts in this episode of the pawdcast, keeping him comfortable, meant giving him five medications that left normally joyful Teddy severely sedated.Marybeth was determined that Teddy would live his best life – no matter how many days, weeks or hopefully months he had. While researching holistic methods to reduce cancer in dogs, MaryBeth developed a “treat” that she began adding to Teddy's food.  MaryBeth believes the anti-inflammatory treat she developed for her beloved Teddy allowed him to remain with her and her family for THREE ADDITIONAL YEARS.MaryBeth shares with Karen and Jean how her singular focus on healing Teddy has become a much broader passion and second career.The treat MaryBeth developed became Teddy's Turmeric Tamer and is now shipped nationwide. It can be found at specialty pet related shops in Northern Virginia.  MaryBeth personally hand fills every order.  For more information visit https://www.teddysturmerictamer.com/ or email MaryBeth at teddystamer@cox.netFrom Teddy's Turmeric Tamer --DISCLAIMER: Product information is not intended to diagnose, treat, cure or prevent any disease. The comments and feedback about our product effectiveness are based on customer, staff, and family opinions and should not be substituted for medical care. We are not liable for any individual reaction to any particular ingredient, therefore, please remember to read the label and ingredient lists carefully and follow the appropriate directions for use and consumption at your own risk. Currently, this product is licensed through the State of Virginia as a “feed” license for a pet treat. For Humans, this has not been approved by the Food & Drug Administration (FDA). ​Turmeric can interact with some medications, so check with your vet/doctor before taking this product especially if your pet takes meds for anti-inflammatory or diabetes.

Secure Freedom Radio Podcast
With Dr. Steve Hatfill

Secure Freedom Radio Podcast

Play Episode Listen Later Oct 20, 2021 52:55


DR. STEVE HATFILL, M.D., Physician, Virologist and Bio-Weapons Expert, Former Fellow, Oxford University and the National Institutes of Health and the National Research Council, Adjunct Assistant Professor of Microbiology, Immunology, and Tropical Medicine, George Washington University School of Medicine and Health Sciences Dr. Steve Hatfill: The first time we had an actual pandemic response plan was during the first term of the Bush administration Has the U.S. Food and Drug Administration (FDA) stopped counting non-life-threatening breakthrough infection cases for COVID-19? Why did the U.S. government downgrade the effectiveness of the Pfizer vaccine? Natural immunity Vs. Covid vaccines: Which is more effective at preventing COVD-19? Back in the mid-1990s, a checklist for how to cope with a biological attack to the homeland was drafted Dr. Hatfill delves into the hydroxychloroquine saga

Concussion Talk Podcast
Episode 102 - First Mobile, Rapid Test for Concussion (Scott Anderson, CCO, SyncThink)

Concussion Talk Podcast

Play Episode Listen Later Oct 19, 2021 19:34


Scott Anderson was on episode 45 introducing many listeners to SyncThink - where he is the Chief Clinical Officer (CCO) - and describing their EYE-SYNC technology. Per the new release, "the US Food and Drug Administration (FDA) has granted clearance of the EYE-SYNC technology as an Aid to Concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis." Please consider supporting Concussion Talk Podcast on Patreon!

Daybreak
New FDA and USG Committee Decisions –– Friday, October 15

Daybreak

Play Episode Listen Later Oct 15, 2021 3:30


A Food and Drug Administration (FDA) panel voted to push Moderna booster shots to the next step, and the Undergraduate Student Government (USG) created a new Lawnparties Review Committee

The 7investing Podcast
7investing Explains: How are Medical Devices and Genetic Tests Regulated?

The 7investing Podcast

Play Episode Listen Later Oct 14, 2021 26:56


Given the rise of exciting new therapeutic modalities ranging from mRNA to gene editing, investors would be forgiven for overlooking opportunities in medical devices. They might be worth a closer look though. In this episode of the 7investing podcast, the team's health-care trio provide a high-level overview of the regulatory environment for medical devices, describe why and how genetic tests are regulated as medical devices, and provide three examples of companies in the space and how they fit within the regulatory landscape. Medical devices are regulated by the U.S. Food and Drug Administration (FDA) within three categories: Class I devices are the simplest and least likely to pose safety risks. Examples include bedpans or medical gauze. These require regulatory clearance. Class II devices are more complicated and require more data within their regulatory submissions to ensure the safety and effectiveness of the device. Examples include X-ray machines or knee braces. These require regulatory clearance. Class III devices are the most complicated and pose the greatest potential risk to patients, such as life-supporting, life-sustaining, or implantable devices. Examples include liquid biopsies, pacemakers, or implantable contact lenses. These require regulatory approval. Although Class I and Class II medical devices can be submitted through the 510(k) process and only need to show equivalence to a predicate ("existing") device, Class III medical devices must be submitted through the more rigorous premarket approval (PMA) process that often requires a clinical trial. Unlike a drug candidate that requires at least three separate clinical trials (phase 1, phase 2, and phase 3), a Class III medical device often only requires a single clinical trial. It seems odd, but genetic tests and liquid biopsies are also regulated as medical devices. These product candidates are categorized into one of the classes above, which typically impacts how and where they can be used. The three designations of genetic tests include: Research use only (RUO) products cannot be used as diagnostics and don't require a regulatory submission. RUOs can form the basis of a more advanced diagnostic product from the originator or its customers. These serve an important role, but generally have the smallest market opportunity. Laboratory developed tests (LDT) must be designed, manufactured, and processed by a single CLIA-certified laboratory. These tend to be Class II medical devices and require a 510(k) filing. LDTs are often used with centralized business models, where patient samples are shipped to a centralized facility. Examples include genetic screening tests. These have the largest volume potential, but low to moderate pricing and insurance coverage. These have moderate to large market opportunities. In vitro diagnostics (IVD) are more robust tests and can be shipped to the point of care, which means placed in the hands of doctors, oncologists, and medical facilities. Because these are not self-contained within CLIA-certified labs, they're often classified as Class III medical devices and require a PMA filing and clinical trial. IVDs are often used with distributed business models, where patient samples are processed at the point of care. Examples include liquid biopsies. These have both large volume and high price potential, which results in the largest market opportunities by monetary value. Finally, the podcast concludes with three different examples of medical device companies: 7investing Lead Advisor Dana Abramovitz discusses Inviate (NYSE: NVTA). 7investing Lead Advisor Maxx Chatsko discusses Nano-X Imaging (NASDAQ: NNOX). 7investing Lead Advisor Simon Erickson discusses STAAR Surgical (NASDAQ: STAA) --- Send in a voice message: https://anchor.fm/7investing/message Support this podcast: https://anchor.fm/7investing/support

Health Quest Podcast with Steve Lankford
395 – Phosphatidyl Serine for Dementia and Cognitive Decline

Health Quest Podcast with Steve Lankford

Play Episode Listen Later Oct 1, 2021 38:57


Phosphatidyl Serine (PS) can play a critical role in both maintaining and improving mental performance – name and face recognition, recalling locations of misplaced objects, concentration, and focus – which is often an unfortunate component of the normal aging process. A multitude of scientific studies have shown that SerinAid PS can significantly help maintain and improve mental performance, can help improve mood, and can make a valuable contribution to lowering both physical and psychological stress. FDA Approved Qualified Claim Recognizing how effective PS really is, the US Food and Drug Administration (FDA), in February, 2003, granted two significant health claims for PS, indicating that PS may reduce the risk of cognitive dysfunction and dementia in the elderly. The post 395 – Phosphatidyl Serine for Dementia and Cognitive Decline appeared first on Health Quest Podcast.

TonioTimeDaily
Abortion law part 3

TonioTimeDaily

Play Episode Listen Later Oct 1, 2021 39:26


TELEMEDICINE AND MEDICATION ABORTION "Telemedicine abortion combines medication abortion, which uses pills to end a pregnancy, with telemedicine, which allows health care providers meet with patients via videoconferencing or telephone consultations. Medication abortion, approved by the FDA for use during the first 10 weeks of pregnancy, uses two different medicines: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy; and misoprostol, which causes contractions. Misoprostol alone is 80-85 percent effective, and in combination with mifepristone is 95 percent effective. Medication abortion is an extremely safe way to end a pregnancy in the first 12 weeks of gestation. According to the Guttmacher Institute, in 2017 medication abortion accounted for approximately 40 percent of all recorded abortions and 60 percent of abortions performed up to 10 weeks gestation. (The actual rate is likely higher because of the growing number of people who are self-managing their abortions using medication purchased on the internet or obtained in other ways.) The growth of medication abortion has dovetailed with the expansion of telehealth to provide new opportunities for accessing abortion health care. As abortion restrictions have increased over the last several years and harassment of people entering health clinics persists — even during the COVID-19 crisis — people are increasingly turning to medication abortion and telehealth to increase their safety and privacy when obtaining abortion care." "In light of COVID-19, and the need for increased social distancing, advocates are increasingly challenging the FDA's REMS restrictions on the abortion pill. This effort is supported by recent research on the safety of a no-test medication abortion protocol that allows doctors to screen patients by phone or video and then mail abortion pills directly to them. On March 30, 2020, a coalition of 21 state attorneys general led by California Attorney General Xavier Becerra sent a strongly-worded letter to the U.S. Department of Health and Human Services and its U.S. Food and Drug Administration (FDA), urging the Trump Administration to waive or utilize its discretion on enforcement of its REMS designation. In addition to the attorneys general letter, reproductive health groups are pressuring the government to remove the REMS restriction on the abortion pill. In July of 2020, a federal judge in Maryland issued a ruling temporarily suspending enforcement of an FDA restriction on abortion pills during the pandemic." --- Send in a voice message: https://anchor.fm/antonio-myers4/message Support this podcast: https://anchor.fm/antonio-myers4/support

Disruptors for GOOD
Bryan Buckley // Co-founder of Helmand Valley Growers Company

Disruptors for GOOD

Play Episode Listen Later Sep 27, 2021 37:17


In episode 115 of the Disruptors for GOOD podcast I speak with Bryan Buckley, Co-founder of Helmand Valley Growers Company and Battle Brothers Foundation, on bringing medical cannabis to military veterans dealing with PTSD and at significant risk of suicide.As a Special Operations Team Commander with Marine Raiders, Bryan led multiple teams in deployments to Operation Enduring Freedom-Trans Sahara (Africa), South East Asia, and Operation Enduring Freedom-Afghanistan (Helmand Province). Developed rapport with numerous host nation forces, enhanced capability and capacity within the host nation units, and briefed US Ambassadors. Led a 20 man Marine Raider Team to Afghanistan that mentored, trained, and conducted over 40 combat operations with an Afghan Special Operations Battalion. Bryan also deployed twice to Operation Iraqi Freedom with Marine Infantry and Marine Reconnaissance.Bryan, is an accomplished sales and operations leader. Distinguished background in leadership, policy, training, management, operations and strategic decision making. Adept in negotiation, alliance formation and organizational communication. Ability to forge productive partnerships among stakeholders and reach high-level decision makers within sophisticated organizations, ensuring free and productive flow of information. Counsel and assist those within and in association with governmental agencies, along with private sector, to adopt best practices in compliance with applicable regulations and statutes. Bryan is a graduate of Villanova University.  Awarded Bronze Star Medal with "Combat Distinguishing Device" for Heroic Service Awarded the Purple Heart Medal for wounds received during combat operations About Helmand Valley Growers Company(HVGC)The Helmand Valley Growers Company was founded by United States Special Operations Veterans (Marine Raiders). Since its inception, HVGC has been in discussions with some of the cannabis industry's top researchers and has developed a veteran based protocol to effectively prove the benefits of medical cannabis.Over time, and through HVGC presentations and seminars, the principles of HVGC realized a recreational brand will be a monetary success and will help fund the ultimate mission of HVGC, providing medical cannabis to the veterans of our United States Military.As a service disabled veteran owned business, HVGC is intimately aware of the daily challenges that veterans face as a result of their time spent on the battlefield. Some of these wounds are not visible to the naked eye.America is facing a wide-scale opioid epidemic that has taken countless lives; not excluded from this crisis, the veteran community has been critically impacted.When the U.S. Military deploys to the combat, roughly 60% of those deployed will be prescribed opioids upon return to the United States, and over half will develop a dependency/addiction.This has caused far too many vets to lose their way, and in an ever-increasing pandemic, take their own lives.HVGC began its outreach into the veteran community by observing first-hand and listening to the suffering of America's veterans. The founders knew right then that the cause was worthy; and that the mission was defined. The next step moved Bryan and the team into researching medical cannabis and speaking with the top experts in the field.As their research progressed, the answer to this crisis became clear: develop alternative medical solutions for those suffering with pain, anxiety, post-traumatic stress, sleep disorders, and most critically, are at significant risk of suicide. The recreational cannabis and branding will be used to assist in accomplishing these goals and ultimately serve as a profit center for HVGC.Medical Cannabis for PTSDIn 2014, a study published in the Journal of Psychoactive Drugs, revealed that patients with PTSD experienced a 75-percent decrease in their symptoms upon using medical cannabis.However, the U.S. Department of Veterans Affairs (VA) is mandated to follow federal regulations regarding cannabis. The Food and Drug Administration (FDA) classifies cannabis as a Schedule I substance, which makes the drug illegal on a federal level. As a result, the VA does not recommend cannabis as a treatment for veterans.Furthermore, cannabis use is prohibited at all VA medical centers, including facilities located in states where cannabis is legal.Listen to more Causeartist podcasts here.Check out:Partner with us - Learn moreImpactInvestor.io - Discover impact investors from around the world.Podcast Made with TransistorPodcast cover design Made with CanvaBuild amazing web platforms with Webflow

Own The Future
Ruling Elite manipulates masses: calls it science. [E260]

Own The Future

Play Episode Listen Later Sep 27, 2021 48:58


HOPE AND FEAR are two levers controlling containing the masses BUT if the 24hr click bait fear cycle of the ruling elite aren't careful it will be the leverage society will need (and use) to break free from their draconian rule. Time Stamps    Intro    00:00    FIGHT CLIMATE!!      46:10    WW3     02:35    Virtue Signaling     03:29    Self Indulgence     04:54    TIMES: No More Babies?     06:07    Man made crisis     08:22    politicians passing the back.     09:09    Gen Z hesitant to have children     10:19    Environmentalism - Humanity is the virus     11:50    Victim-hood     13:01    The Future belongs to the bold     15:19    Your Purpose: solve problems     16:50    Taliban hangs people in city streets     19:18    West uses refined fear-mongering     20:25    Taliban PRO cutting hands     22:27    Taliban leveraging social media     23:10    UN warns of looming famine in Afghanistan     24:43    Norway goes back to normal     26:31    Covid pill months away     28:15    Fear and Hope - Hunger Games     30:13    Australia Protests  and Police Canvasing     32:47    Former Food and Drug Administration (FDA) commissioner Scott Gottliebsaid     35:55    Yeah That Makes Sense     38:17    The Alphabet Agenda     38:32    How many more letters? Infinite!     41:20    Value for Value     42:20    Weaver and Loom     43:29    Charlie Mackesy     44:49    What is Success?     45:41    Build others up     47:40    Outro     48:37 Detailed Show Notes and Media/Article links: http://260.lucasskrobot.com/VALUE FOR VALUE- If you get value out of this show— support the show in the value that you've received. You can do that by visiting the website and giving Fiat currency thereORYou can stream bitcoin by listening Podcasting 2.0 Certified apps: Podfriend - Breez - Sphinx – Podstation To find one visit http://newpodcastapps.com and find a player with the “VALUE” tag. I personally listen on Breez. If you want to get MORE value out of the show, talk about it with a colleague or co worker, or friend. You will begin to build (hopefully) stronger relationship and culture through texting this to a friend and then talking about the concepts discussed here. Remember, as leaders our first job is to define reality and define culture and that is done brick by brick. Until next time… uncover your purpose, discern the Truth, and own the future.To take more steps to live a focus life to achieve your dreams and fulfill your destiny–get my book Anchored the Discipline to Stop Drifting.  https://amzn.to/2Vwb22nThank you for listening, and as always you can find me at:WhatsApp: +1-202-922-0220http://www.LucasSkrobot.comTiktok: https://www.tiktok.com/@lucasskrobotLinkedIn: https://www.linkedin.com/in/lucasskrobotInstagram: https://www.instagram.com/lucasskrobot★ Support this podcast ★

Rio Bravo qWeek
Episode 67 - Covid, Food, and HIV

Rio Bravo qWeek

Play Episode Listen Later Sep 24, 2021 19:03


Episode 67: Covid, Food, and HIV.  Medical students discuss the relationship between high cholesterol and COVID-19, the effect of food order in postprandial glucose and insulin, and HIV history. Moderated by Hector Arreaza, MD.  During this episode you will listen to three medical students discussing some topics that they found interesting during their family medicine rotation. All the credit goes to them because they read these topics and provided a very good summary. I hope you enjoy it.____________________High Cholesterol and COVID-19By Milan Hinesman, MS3, Ross University School of MedicineGiven the current state of the world, there's been a lot more attention to COVID-19 presentation, risks, and treatment. One study conducted by Dr. Kun Zhang and collaborators shows that there may be a relationship between higher total cholesterol levels and ApoB levels to increased risk of COVID-19 infection[1]. Dr. Zhang used a mendelian randomization from the UK Biobank data to test for lipid effects on COVID susceptibility and severity. The study performed analysis of data from the host genetics initiative consisting of more than 14,000 cases and more than one million controls showing a potential positive causal effect between high total cholesterol and ApoB and COVID susceptibility. A mendelian randomization is a process of taking genes which functions are already known and measuring their response to exposure to a disease in observational studies[2]. In short, high cholesterol and high ApoB are linked to COVID-19 infection.This is Rio Bravo qWeek, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California. Our program is affiliated with UCLA, and it's sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home. __________________________Impact of food order on glucose after meals.   By Yvette Singh, MS3, American University of the CaribbeanIn the management of diabetes, health care providers usually assess glycemic control with fasting plasma glucose and pre-prandial glucose measurements, as well as by measuring Hemoglobin A1c. Therapeutic goals for Hemoglobin A1c and pre-prandial glucose levels have been established based on the results of controlled clinical trials. Unfortunately, many patients with diabetes fail to achieve their glycemic goals. Elevated glucose after eating may be the cause of poor glycemic control leading to vascular complications. Postprandial hyperglycemia is one of the earliest abnormalities of glucose homeostasis associated with type 2 diabetes. This is one of the important therapeutic targets for glycemic control. Current studies show that the amount and timing of carbs in the diet primarily influence blood glucose levels. Other studies also show that eating whey protein before meals, as well as changing the macronutrients in meals, reduces postprandial glucose levels; however, these studies did not have patients with type 2 diabetes. The main author of this study was Alpana P. Shukla and many other collaborators. The title is Food Order Has a Significant Impact on Postprandial Glucose and Insulin Levels, published by the American Diabetes Association on Diabetes Care in July 2015.This study was performed to analyze the order of food consumption with vegetables, protein and carbohydrates and its effects on postprandial glucose in overweight/obese patients with type 2 diabetes being treated with metformin. Subjects were studied for 1 week. They were given a meal with the same number of calories, after fasting for 12 hours: 55g protein, 68g carbs, and 16g fat. They were asked to eat carbs first, then to eat vegetables and protein fifteen minutes later. This order was reversed during the second week. Their postprandial glucose and insulin levels were measured at 30/60/120 mins after meals. The statistical studies showed an average post prandial glucose decrease by more than 25% when protein was consumed first. As well as the average post prandial insulin levels decreased by more than 40%. These results demonstrated that the timing of carbs during a meal has a significant impact on glucose and insulin levels comparable to some pharmacological agents. Reduced insulin excretion with this meal pattern may also improve insulin sensitivity. This may help patients with type 2 diabetes control their HbA1c, and possibly help reverse early diabetes. Educating patients about this approach is not controlling how much they are eating or restricting their diet so patients will likely comply with this recommendation. Eat your protein first!The potential problems of this study are that it was a small sample size (11 patients), limited food types, and insulin was measured only up to 120 minutes after meals. Further studies are needed to demonstrate the full effectiveness of this recommendation.___________________HIV Series Part I: HIV HistoryBy Robert Dunn, MS3, Ross University School of Medicine This is an HIV series for the Rio Bravo qWeek Podcast. The following episodes will include some of the history of HIV, transmissibility, the PARTNER-1 and PARTNER-2 studies, and will finalize with a full episode on HIV prevention. Today we are starting with HIV history.Prejudice against those with HIV stems from the history surrounding the virus. Between 1981-1983, cases of rare infections like Pneumocystis carinii pneumonia (PCP) and aggressive cancers like Kaposi Sarcoma were appearing predominantly amongst gay men and injection drug users.  Even children were presenting with AIDS creating misconceptions of how the disease was transmitted by touch. By 1982, this syndrome was referred to as the Gay-Related Immunodeficiency (GRID), which we now know as AIDS. Some History of HIVThe start of the Human Immunodeficiency Virus (HIV) was thought to have started in the Democratic Republic of Congo in 1920 when the virus crossed species to humans and gave its ability to infect humans[4]. In 1981, five young gay men in Los Angeles, California, presented with a rare lung infection called Pneumocystis carinii pneumonia (PCP). Two other groups of men also presented with a rare and aggressive cancer called Kaposi Sarcoma, in New York and California. By December of the same year, the first case of PCP was found in an injection drug user. And by the end of the year, there were 270 reported cases of this severe immunodeficiency and about 121 of them had already died from it, almost 50%. In 1982, due to the prevalence of these rare diseases being present among gay men, the syndrome was called the Gay-Related Immune Deficiency (GRID). The CDC later officially called the disease the Acquired Immune Deficiency Syndrome (AIDS). The term “gay cancer” was used in Venezuela before AIDS was known.In 1983, the disease was found in both women and children. In May 1983, in a joint conference between the Pasteur Institute in France and the National Cancer Institute, they announced that LAV and HTLV-III were the same virus and the cause of AIDS.In 1985, Ryan White, a teenager with hemophilia was banned from school when he was diagnosed with HIV after he received contaminated blood products. Ryan later died at 18 years old due to AIDS-related illnesses. At the same time, the FDA licensed the first commercial blood test to detect HIV. A foundation was later created to provide primary care and medications for low-income HIV patients.In 1987, the first antiretroviral drug, Zidovudine (AZT) was approved by the FDA to treat for HIV. In 1991, the famous basketball player Magic Johnson announced he tested positive for HIV and retired immediately. After his retirement he planned to educate young people about the virus which helped dispel stereotypes. Also in 1991, the famous singer of Queen announced he had AIDS and died the next day.In 1993, the movie Philadelphia with Tom Hanks promoted further discussion about HIV and AIDS. In June 1995, the first protease inhibitor was approved by the Food and Drug Administration (FDA), which started the era for Highly Active Antiretroviral Therapy (HAART). This brought down the rate of AIDS-related deaths and hospitalizations by 60-80%. Of special note, in 1986, the FDA passed the policy to ban all men who had sex with men (MSM) from 1977 onward, from donating blood or plasma to avoid the risk of transmitting HIV or Hepatitis A. This policy was amended in December 2015, when the revised policy said any MSM within the last 12 months, would need to wait at least 1 year before donating blood. In light of the COVID-19 pandemic, the FDA amended it its policy once more to decrease the wait time to 3 months form the last time the man had sex with another man.____________________________Conclusion: Now we conclude our episode number 67 “Covid, Food, and HIV.” Kudos to Milan, Yvette and Robert, they presented relevant information for our practice of medicine. They taught us that high cholesterol is a risk for COVID-19 infection; Also, when you eat proteins first, your glucose and insulin after meals are lower than when you eat carbs first; and you will be hearing from Robert for a couple episodes regarding HIV. Today he gave us a little piece of HIV history. Even without trying, every night you go to bed being a little wiser.Thanks for listening to Rio Bravo qWeek. If you have any feedback about this podcast, contact us by email RBresidency@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. This podcast was created with educational purposes only. Visit your primary care physician for additional medical advice. This week we thank Hector Arreaza, Milan Hinesman, Yvette Singh, and Robert Dunn. Audio edition: Suraj Amrutia. See you next week! _____________________References:Zhang, K. Dong, S. Guo, et. al., Causal Associations Between Blood Lipids and COVID-19 Risk: A Two-Sample Mendelian Randomization Study. Arteriosclerosis, Thrombosis, and Vascular Biology, originally published on September 9, 2021. https://doi.org/10.1161/ATVBAHA.121.316324. What is Mendelian Randomization and How Can it be Used as a Tool for Medicine and Public Health? Opportunities and Challenges, Webinar announcement given by Professor George Davey Smith on November 27, 2018. Centers for Disease Control and Prevention, https://www.cdc.gov/genomics/events/precision_med_pop.htm Alpana P. Shukla, Radu G. Iliescu, Catherine E. Thomas and Louis J. Aronne, Food Order Has a Significant Impact on Postprandial Glucose and Insulin Levels, Diabetes Care 2015 Jul; 38(7): e98-e99. https://doi.org/10.2337/dc15-0429. History of HIV and AIDS Overview. Avert, October 10, 2019. https://www.avert.org/professionals/history-hiv-aids/overview. Accessed on September 21, 2021. Shaw, Maggie. FDA's Revised Blood Donation Guidance for Gay Men Still Courts Controversy. AJMC, April 3, 2020. https://ajmc.com/view/fdas-revised-blood-donation-guidance-for-gay-men-still-courts-controvery. Accessed on September 21, 2021. BAYER, R. (2015), Science, Politics, and the End of the Lifelong Gay Blood Donor Ban. Milbank Quarterly, 93: 230-233. https://doi.org/10.1111/1468-0009.12114. Ways HIV can be Transmitted. Centers for Disease Control and Prevention, April 21, 2021. https://www.cdc.gov/hiv/basics/hiv-transmission/ways-people-get-hiv.html. Accessed on September 21, 2021.

The Critical Hour
Clinton Lawyer Indicted for Russia-gate Lies; France Recalls Ambassador Over AUKUS

The Critical Hour

Play Episode Listen Later Sep 21, 2021 116:32


Alexander Mercouris, editor in chief at theduran.com and host of "The Duran" on YouTube, joins us to discuss Russia-gate. A Clinton campaign lawyer has been indicted in connection with spreading falsehoods and lying to push the Russia-gate narrative. Special counsel John Durham has levied charges against attorney Michaels Sussman for lying to the FBI about his connections to the Clinton campaign. Sussman allegedly told the FBI that he was not representing any political entity as he passed on false information, but documents reveal that he was billing the Clinton campaign for the interview in which he made that claim. Scott Ritter, former UN weapon inspector in Iraq, joins us to discuss AUKUS. US and French diplomats are scrambling to clean up a geostrategic mess as the US has stolen massive military contracts from France. Also, France has recalled its ambassador to the US, and the EU power is flexing its muscles against the US empire. Will France back down, or will the US strike out at its long-time ally?Dr. Iyabo Obasanjo, professor, epidemiologist, veterinarian, and the daughter of former Nigerian president Mr. Olusegun Obasanjo, joins us to discuss covid. Advisers at the Food and Drug Administration (FDA) have refused to authorize a third booster shot for vaccinated Americans, but did ok it for the population of 65 and over. Also, a number of big cats have tested positive for covid at the National Zoo, and hospitals in some rural states are facing tough decisions.Laith Marouf, broadcaster and journalist based in Beirut, joins us to discuss the Middle East. The US is levying sanctions on Hong Kong companies for allegedly doing business with Iranians in violation of US rules. Also, Iran has announced that they are going to sell oil directly to Lebanon, and the EU is considering more sanctions on Beirut.Marjorie Cohn, professor of law at the Thomas Jefferson School of Law in San Diego, joins us to discuss her book about drones and targeted killings. Cohn has written an extensive book about drones, and our guests talk to her about the many violations of US and international law created by the US program. Steve Poikonen, national organizer for Action4Assange, joins us to discuss Pentagon spending. Anti-war activists are pushing back against a questionable Biden administration plan to provide helicopter maintenance to Saudi Arabia for 500 million dollars. Also, William Astore has penned an article in which he proposes that the weapons manufacturers are the perpetual winners in Afghanistan-style wars of occupation.Nino Pagliccia, activist and writer, joins us to discuss the Global South. China has come out firmly against the US-sponsored illegal detention of Alex Saab. Saab was working on a diplomatic mission for Venezuela when he was captured by US empire lackeys. Also, the president of Mexico has come out to openly condemn the US blockade of Cuba. Dr. Linwood Tauheed, associate professor of economics at the University of Missouri- Kansas City, joins us to discuss neoliberalism. In his article "(Neoliberalism) and its discontents," Francis Lee compares classical liberalism to the current neoliberal political movement. He then goes on to discuss how and why neoliberal politics conflicts with traditional collectivist political movements and philosophies.

Red Star Radio
*Unlocked* The Real Face of the FDA

Red Star Radio

Play Episode Listen Later Sep 17, 2021 77:11


We are unlocking this episode recently released to patrons as it contains a lot of useful information on the role regulatory bodies actually play under state monopoly capitalism. What role does a regulator like the Food & Drug Administration (FDA) actually play? In this episode we examine the FDA, it's capture and control by the pharmaceutical industry and how this fits into US state-monopoly capitalism. Be sure to read the full article we are discussing Episode image is taken from the Lindsay Anderson film "Britannia Hospital" (1982)

The_C.O.W.S.
The C.O.W.S. Compensatory Call-In 08/28/21 #MilkCrateChallenge

The_C.O.W.S.

Play Episode Listen Later Aug 29, 2021


The Context of White Supremacy hosts the weekly Compensatory Call-In. We encourage non-white listeners to dial in with their codified concepts, new terms, observations, research findings, workplace problems or triumphs, and/or suggestions on how best to Replace White Supremacy With Justice ASAP. We'll use these sessions to hone our use of words as tools to reveal truth, neutralize White people. We'll examine news reports from the past seven days and – hopefully – promote a constructive dialog. #ANTIBLACKNESS There were a multitude of momentous events this week. The Food and Drug Administration (FDA) formally approved the Pfizer coronavirus vaccine. This led to the Pentagon and other employers mandating vaccines for all employees, and President Biden strongly encouraged other companies to do the same. The Taliban is accused of a terrorist attack on a Kabul airport, where at least 60 Afghans (non-white people) and thirteen U.S. citizens perished. These events were drowned out in some quarters where attention was focused on the so called "milk crate challenge." Conspicuously, viral videos erupted where almost exclusively black people harmed themselves while scaling a pyramid of milk crates. The very same FDA commented that before joining the challenge, folks should check with their hospital to be sure beds are available. #VaccineSurcharge INVEST in The COWS – http://paypal.me/TheCOWS Cash App: https://cash.app/$TheCOWS CALL IN NUMBER: 720.716.7300 CODE: 564943#