Better Living Through Well Being
I think it is fair to say most people for whatever reason are relieved to finally be in a new year. This year as the pandemic continues, rather than rush forward with resolutions as we would have in many years past, we look around ourselves and try to see reasons for hope emerging together with a cautious optimism that has us not drawing quick conclusions about what we see unfolding. It is as if we all want to wait to see "what will happen."
We have witnessed healthcare professionals rise to the unrelenting challenges of 2020 with skill, ingenuity, fortitude and compassion. We feel empathy for those who lost loved ones due to COVID-19, and for essential workers who are now coping with the traumatic aftermath of having risked their lives on the frontlines. We have seen people working together in unity and solidarity out of necessity, people extending a helping hand to neighbors and strangers, scientists developing vaccines in record time.
It is a sign of hope that the past year has demonstrated our ability to adapt, yet most of us still have a need and expectation for a level of predictability, stability and control in the world around us that we fear may not be met. The rollout of coronavirus vaccines holds the promise of returning to some sense of normality. Many jobs have been lost and many of those will never come back, but in the new economy unfolding there may be economic opportunities that can be seized, and new forms of working emerging.
I find hope in these words of Francis Collins, Director of the National Institutes of Health, "There is now a light beginning to appear at the end of this long tunnel, with science having risen to the occasion and brought forth solutions that we almost dared not hope for. And yet, here they are."
Clinical trial results of the Moderna COVID-19 vaccine have been published in The New England Journal of Medicine. The studies, conducted between late July and October 2020, found an overall vaccine efficacy rate of 94.1 percent among 30,420 volunteers. Aside from transient local and systemic reactions, no safety concerns were identified. Phase 3 was a randomized, stratified, observer-blinded, placebo-controlled trial of adults in medically stable condition at 99 U.S. sites.
The Moderna vaccine received emergency use authorization from the U.S. Food and Drug Administration (FDA) on December 18, 2020 and has become the second approved vaccine in the U.S. It is being given initially to vulnerable and exposed populations and is expected to be widely available over the coming months in the U.S., Canada, European Union, Israel, Switzerland, and the U.K. Like the Pfizer vaccine, which was authorized weeks earlier, it is made from mRNA, a new technology tested for many other diseases in the past, but only recently developed for the coronavirus.
While recipients still show strong immune response three months after vaccination, it is not clear how long this efficacy will last. It is also not clear whether people can still transmit the disease to others if they’ve been immunized.
In view of the clear need for a diagnostic tool that provides information regarding immunity levels and efficacy durations for those who have been immunized, a new ground-breaking clinical trial has been initiated in Israel. This first-of-a-kind trial will map specific biomarkers to type IgM and IgG antibody responses by means of rapid breath test technology. This test will provide a quick indication as to the efficacy of all vaccines on the market, the Pfizer-BioNTech and Moderna vaccines currently in use, as well as many more vaccines that are expected to come on to the market in the near future.
This same breath test technology is also under development for use as a rapid breath test for coronavirus detection. The test is believed to detect both symptomatic coronavirus active carriers and asymptomatic carriers. So far it has been able to detect differences among various test groups: positive subjects, negative subjects, and negative subjects with antibodies for the coronavirus.
The FDA has issued an alert to clinical laboratory staff and health care providers that they are monitoring the potential impact of emerging viral mutations, such as the one recently found in the U.K., to determine accuracy of all currently authorized molecular tests used to detect the coronavirus. Data analysis is ongoing, but so far the FDA believes the risk of these mutations impacting overall testing accuracy is low. Also, tests that only rely on the detection of multiple regions of the virus genome may be less impacted by genetic variation than tests that rely on the detection of only a single region.
The FDA alert is meant as a reminder that all laboratory tests carry some risk of false negative results even if only minimal. Adverse or suspected adverse events experienced with molecular testing for detection of SARS-CoV-2 (coronavirus) are requested to be submitted through Med Watch, the FDA Safety Information and Adverse Event Reporting program.
Other articles of interest in this TMIS eNewsletter for Winter 2021:
* Nationwide survey reveals 34 million Americans living with diabetes face challenges to their health resulting from the COVID-19 pandemic due to economic fallout and barriers to healthcare and food
* First of its kind human study reveals strong links between specific gut microbes, diet and health, including obesity, diabetes, and heart disease
* Origins of COVID-19 and the manner in which it spread so quickly
* COVID Alert Network offers free, fully automated track & trace network using technology available on smartphones, no app download required
* Further research into psilocybin opens new doors for treatment as perceptions shift from a potentially dangerous party drug to an approachable medicinal product
* Key areas of risk for global organizations beyond continued impact of COVID-19 include natural disasters, faceless threats, supply chain disruption, cyber attacks, decay of the ‘social contract’ and erosion of domestic political cohesion fueled by social media
* United Nations’ 75th anniversary initiative affirms belief in international cooperation in a post-COVID-19 world
* Demand for farmland continues to drive current land surge in the U.S.
I am grateful to be in a collaborative business with many talented and skilled professionals. Additional feedback and recommendations for TM Information Services are always welcome.
- Mary Michele McLaughlin
From the Front Page of TMIS News
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Research Centers of America Expedite Broad Study on Moderna's COVID-19 Vaccine
Research Centers of America (RCA), a CenExel Center of Excellence, joined nearly 100 other clinical research facilities across the United States to test the safety and efficacy of Moderna's mRNA-1273 vaccine against COVID-19. The published results in The New England Journal of Medicine showcased that the trial enrolled 30,420 volunteers and found an overall vaccine efficacy rate of 94.1%. Although moderate, short-lived reactogenicity occurred more often in the mRNA-1273 group, these reactions are typical for vaccinations. Severe adverse events were rare and occurred roughly as often between both the placebo and mRNA-1273 groups.
Dr. Howard Schwartz, Chief Medical Officer and Principal Investigator at RCA and a widely-published author, contributed the Center's findings to the study as part of his authoring partnership for the article. "The data demonstrated strong safety and efficacy results from a novel mRNA COVID-19 vaccine," he said. "These welcome and extremely positive indications are a breath of fresh air after a turbulent year."
RCA and the entire 5-site CenExel network were uniquely positioned to move this study forward by relying on their profound experience in vaccine research and on-site labs for working with peripheral blood mononuclear cells (PBMC). Professional, full-time staff at these clinical trial facilities have conducted extensive research on vaccines for many viruses already, including seasonal and pandemic influenza, Ebola, smallpox, West Nile Virus, and Zika. The PBMC labs allow for the isolation, cryopreservation, and shipping of PBMC, which is essential for accurate results in a vaccine trial.
"Our whole site network has been able to participate in key studies in Operation Warp Speed," said Tom Wardle, CenExel CEO. "In the past several years, our Centers have supported over 100 vaccine trials and surpassed recruitment goals by 110%. We have enrolled over 5,000 patients in six of the seven Operation Warp Speed studies, with 40% of the patients representing diverse minority groups. Throughout these efforts, we maintained the strictest safety measures and the highest quality of work."
Rapid breath test for Covid-19 detection to evaluate the efficacy of the vaccines including the Pfizer-BioNTech's vaccine
NextGen Biomed Ltd. reports that Scentech-Medical received approval from the Shamir Medical Center (Asaf Harofe) Review Board (Helsinki committee) for a new clinical trial. Scentech-Medical has initiated this trial, which to the best of the company's knowledge is the first of its kind in the world, to demonstrate the company's ability to monitor the antibody levels and type of antibodies developed by the population of subjects getting vaccinated for the coronavirus.
As part of the research, Scentech-Medical will test subjects getting vaccinated to map biomarkers specifically related to antibodies of type IgM and IgG. The test to monitor antibody levels and type (which is being developed concurrently with the rapid breath test for coronavirus detection) will be able to provide a quick indication as to the efficacy of all vaccines available on the market, including the Pfizer-BioNTech vaccine. Moreover, such a test has the potential to indicate the immune system's response to various types of vaccines.
In light of the knowledge gained so far on the coronavirus, which has been active all year, there is a clear need for a diagnostic tool that can provide information regarding the immunity levels and efficacy durations of those immunized. Monitoring antibody levels and type of antibodies is of utmost importance due to the fact that there are multiple coronavirus vaccines available on the market and even more expected to come to market in the near future.
FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
Silver Spring, Maryland
The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus's genome assessed by that test. The SARS-CoV-2 virus can mutate over time, like all viruses, resulting in genetic variation in the population of circulating viral strains, as seen with the B.1.1.7 variant. The FDA is taking additional actions to ensure authorized tests remain accurate by working with test developers and conducting ongoing data analysis to evaluate all currently authorized molecular tests. The FDA believes the risk that these mutations will impact overall testing accuracy is low.
"The FDA will continue to monitor SARS-CoV-2 genetic viral variants to ensure authorized tests continue to provide accurate results for patients," said FDA Commissioner Stephen M. Hahn, M.D. "While these efforts continue, we are working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants. At this time, we believe the data suggests that the currently authorized COVID-19 vaccines may still be effective against this strain. The FDA will continue to keep health care providers and the public informed of any new information as it becomes available."
COVID-19 Brings Crisis of Access for Millions Living with Diabetes
According to a new nationwide survey, the 34 million Americans living with diabetes face unique, acute and intensified challenges to their health as a result of the COVID-19 pandemic – challenges that may increase their COVID risk for complications. The study, released by the American Diabetes Association in partnership with Thrivable and the Diabetes Daily community, shows that the financial and economic toll of the pandemic has left scores of Americans with diabetes without access to the drugs, devices, insurance, and food that they need to properly manage their diabetes or even survive during this time.
While the data focus on the circumstances faced by people with diabetes during the pandemic, the effects of the trends uncovered by the study may last well beyond the crisis, creating what may be dangerous long-term repercussions for the health of this community and placing new strains on the health care system.
"For months we have known that people with diabetes are at heightened risk during COVID. Yet what this data show is that the level of adversity facing our community from this crisis is at an even more critical point," said Tracey D. Brown, CEO of the American Diabetes Association. "As many as 40 percent of the COVID fatalities -- 120,000 Americans -- have been people with diabetes, and more in our community may be at risk of the worst of the virus' effects because so many are now unable to manage their diabetes effectively. Now we must be even more mindful that our community, which includes an outsized portion of people of color and those of lesser means, must be a priority for relief efforts, including prioritized access to the COVID vaccine."
Landmark human study is first to reveal strong links between specific gut microbes, diet and health, including weight
A large scale international study published in Nature Medicine on January 11, 2021 demonstrates the clear link between specific gut microbes and the foods we eat on health and disease, and also reveals newly discovered microbes. For the very first time, scientists have studied a large enough sample to begin to understand the microbes that impact many of the health conditions we are faced with today: obesity, cardiovascular disease, visceral, insulin resistance and weight gain.
Diets rich in certain plant-based foods are linked with the presence of gut microbes that are associated with a lower risk of developing conditions such as obesity, type 2 diabetes and cardiovascular disease, according to recent results from a large-scale international study that included researchers from King's College London, Harvard T.H. Chan School of Public Health, Massachusetts General Hospital (MGH), University of Trento, Italy, and health science start-up company ZOE. The study uses metagenomics and blood chemical profiling to uncover a panel of 15 gut microbes associated with lower risks (and 15 with higher risks) for common illnesses such as diabetes and heart disease (short introductory video).
The PREDICT 1 study analyzed detailed data on the composition of participants' gut microbiomes, their dietary habits, and cardiometabolic blood biomarkers. The researchers found evidence that the microbiome is linked with specific foods and diets, and that, in turn, certain microbes in the gut are linked to biomarkers of metabolic disease. Surprisingly, the microbiome has a greater association to these markers than other factors, such as genetics. Their report, authored by Dr. Francesco Asnicar (University of Trento) and Dr. Sarah Berry (King's College London) and coordinated by Tim Spector (King's College London) and Nicola Segata (University of Trento), appears in Nature Medicine.
Dr. Sarah Berry, Reader in Nutrition Sciences at King's College London said, "As a nutritional scientist, finding novel microbes that are linked to specific foods, as well as metabolic health, is exciting. Given the highly personalized composition of each individuals' microbiome, our research suggests that we may be able to modify our gut microbiome to optimize our health by choosing the best foods for our unique biology."
For example, the findings reveal that having a microbiome rich in Prevotella copri and Blastocystis species was associated with maintaining a favorable blood sugar level after a meal. Other species were linked to lower post-meal levels of blood fats and markers of inflammation.
Professor Tim Spector, Epidemiologist from King's College London, who started the PREDICT study program and is scientific founder of ZOE explains, "When you eat, you're not just nourishing your body, you're feeding the trillions of microbes that live inside your gut."
COVID-19 Origin and Spread Linked to PLA Hospital and Wuhan Metro System Line 2
Dr. Steven Quay, M.D., PhD., head of two COVID-19 therapeutic programs at Atossa Therapeutics, Inc., recently shared his latest research and findings regarding the origins of COVID-19 and the manner in which it spread so quickly.
He says that looking at the origins of the virus is crucial in order to fully understand how it infects humans and to develop better treatments. Dr. Quay said that "in investigating that process, I found an unusual pattern in what's called a genetic cluster." He goes on to say that there were four patients with "literally the same virus, or only a tiny number of changes that represent the first version of the virus, SARS-CoV-2, that entered humans.
The four patients were seen at the People's Liberation Army Hospital in Wuhan, China, which is 100 meters from Line 2 of the Wuhan Metro System. Dr. Quay invites viewers to ponder the following questions: Were the four patients on a military mission together to southern China and caught the virus there? Do they have another relationship? Why were they at the military hospital at that time?
Dr. Quay then took this information and linked the first 100 patients in Wuhan to that same subway line, which carries one million people per day. Line 2 also has a station to the high-speed rail system, connecting all of China in a few hours, and ends at the Wuhan International Airport, with daily flights around the world.
Stay Safe America Launches COVID Alert Network
New York, New York
The first nationwide, fully automated, COVID Track & Trace Network has gone live. The COVID Alert Network offers new hope to every American to stop the spread of COVID and buy time for the vaccine to take effect.
Human attempts at Track & Trace have not met the scale necessary to tackle the COVID challenge. Less than 10% of Americans have downloaded a COVID Alert App and most Americans are reluctant to share their personal data.
David, Head of Campaign at Stay Safe America, warned, "If we do nothing and wait for the vaccine, 1 in every 1,000 Americans may not make it to the Summer. We need everyone to join the fight and become a local hero by either downloading a location aware poster for their business or scanning these posters wherever they go.
"The COVID Alert Network is ready to scale to over 330 million Americans and is already available in every state. No app download is required, as we use technology already available on modern smartphones.
"No personal data is required as we track the device NOT the individual. The network is therefore completely confidential and anonymous."
Further Research into Psilocybin Opens New Doors for Treatment
New York, New York
Among the popular fields of study for biotech companies in recent years are gene editing, tissue engineering and regeneration, nanobiotechnology and others. In addition, new segments under the biotech umbrella are constantly being developed. For example, the medical cannabis segment has rapidly emerged in recent years, and the continuously growing acceptance of psychedelic drugs is further evidence. The perceptions about psychedelics and their possible uses have also started to shift from a potentially dangerous party drug to an approachable medicinal product. For example, earlier in 2019, the U.S. Food and Drug Administration (FDA) approved Spravato (esketamine) a nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Also, in 2019, the FDA awarded the second Breakthrough Therapy designation to non-profit Usona Institute, which is studying the effects of psilocybin as an anti-depressant. Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms.
James Kuo, the CEO and co-founder of California-based Tryp Therapeutics, explained, according to a report by Forbes, that while psilocybin remains among the most restricted drugs in North America, recent changes in regulations are enabling more clinical research and trials of the substance to be carried out. "These substances [including psilocybin] will become more available with their safety being demonstrated over time … Over-the-counter happened with some of the older medications -- they were initially available at drugstores for prescriptions only… but I think people with very specific medical problems, such as pain or eating disorders, will be the most likely to adopt the type of functional food with psychiatric care components."
Healix Risk Oracle report for 2021 identifies six key risks beyond the pandemic
International risk management and assistance expert, Healix International, has identified six key areas of risk, besides the continued impact of COVID-19, for global organizations in its 2021 Risk Oracle report.
As Chris Job MBE, Director, Risk Management Services, Healix International explains, it is vital for organizations with an international footprint to ensure that the myriad of risks beyond the coronavirus remain a focus. "2021 is likely to be as busy a year for challenging global events, some predictable and some unprecedented. Overlay this expectation with a new and as yet undefined normal and a global drive for economic growth, the need for robust organizational resilience plans is clear. The key now is to ensure consistent and reliable monitoring is combined with access to the most appropriate resources to ensure employee wellbeing remains the priority."
Citizens globally affirm belief in international cooperation
New York, New York
The UN75 initiative was launched by Secretary-General António Guterres, in January last year, to understand the global public's hopes and fears for the future, as well as their expectations and ideas for international cooperation, and for the UN in particular. More than 1.5 million people from 195 countries took part in the campaign through surveys and dialogues.
Watch UN short video UN75: 2020 and beyond.
“The UN75 global consultation showed that 97 per cent of respondents support international cooperation to tackle global challenges,” Mr. Guterres said on the results.
“That represents a very strong commitment to multilateralism, and to the mission of the United Nations. Now it is up to us -- Member States and the UN Secretariat -- to meet the expectations of the people we serve,” he added.
Will the Surge in Land Prices Continue?
What started out with better than expected sales prices at land auctions prior to fall harvest extended into very strong prices at some auctions during October and November, surprising many.
"Farmers National Company had auction sales in several states during this time where land sold near levels last seen in 2012. In specific instances, prices for good quality cropland in the heart of the Midwest are up hundreds to thousands of dollars per acre more than anticipated," said Randy Dickhut, senior vice president of real estate operations at Farmers National Company.
What is propelling the land market and will this current surge in prices continue?
Agricultural land prices have been fairly stable in the past several years despite the gyrations of the ag economy. Producer incomes were taking hits, but the land market took it in stride except for the hardest hit areas or segments. The factors supporting the land market remained constant during this time, which included historically low interest rates, a lower supply of land for sale and adequate demand for good cropland about everywhere.
The demand for land is the driver of the current land price surge.
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