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>>> Abbott gets FTC notice for information on infant formula products
Reuters
February 17, 2023
https://news.yahoo.com/abbott-gets-ftc-notice-information-222145991.html
(Reuters) -Abbott Laboratories said on Friday it received a civil investigative demand in January from the Federal Trade Commission related to a probe of the companies participating in bids for women, infants and children formula contracts.
Panicked parents had emptied baby formula aisles at supermarkets last year as a recall of formulas produced at an Abbott facility in Michigan over complaints of bacterial infections worsened a shortage started by pandemic-led supply chain issues.
The FTC had launched an inquiry last year into the shortage for infant formula in the United States and had said it would examine the pattern of mergers and acquisitions in the formula market.
The agency declined to comment on the matter on Friday.
The Wall Street Journal had reported in January that Abbott's Michigan plant faced a criminal investigation by the Justice Department.
On Friday, Abbott said in a regulatory filing that multiple civil lawsuits have been filed against the company regarding its manufacturing of certain powder infant formula products.
Shares of the company were down 1.4% in extended trading.
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United Healthcare - >>> Why you should care about CVS acquiring Oak Street Health
Yahoo Finance
by Anjalee Khemlani
February 13, 2023
https://finance.yahoo.com/news/why-you-should-care-about-cvs-acquiring-oak-street-health-221052049.html
CVS's (CVS) announcement of its $10.6 billion deal for Oak Street Health (OSH) is just the latest example of how major health-care players are slowly expanding their reach throughout different segments of the industry.
In the past two decades, CVS has acquired an insurance company (Aetna), a pharmacy benefits manager (Caremark), launched its Minute Clinic, and is now expanding into more clinical care services. In addition, it is pursuing a strategy to help to diversify clinical trials.
All the major health care companies are in some way pursuing what is known as "vertical integration," or combining their business with other segments of the health industry.
Take for example the biggest commercial insurer, United Healthcare (UNH). It has the Optum brand, a pharmacy benefit manager and a healthcare provider used in physician's offices, and OptumRx which helps United compete in the pharmacy benefits space.
Experts have ongoing worries about the impact of these behemoth companies, especially the quality of care received by patients.
But there may not be enough data yet to determine if the benefits — ideally lower costs and better patient adherence to care plans — outweigh the risks of more centralized industry control.
In a separate, recent report from the New England Journal of Medicine's Catalyst group, CVS chief medical officer Dr. David Fairchild said the pandemic showed patients' affinity for convenience in health care.
"I think the health care industry still needs to focus on how to make health care more convenient and accessible because this is what people want and need," Fairchild said.
Oak Street Health, whose patients are older adults, is focused on a type of payment model that has been long-discussed but which has never taken off in a big way: value-based care.
This, according to health economist Craig Garthwaite, is key.
"If people have always said the problem with U.S. health care is the fee-for-service system where we don't really have a system to buy health, we have a system to buy health care services and everyone in this system makes money when you consumer more care...this takes away that incentive," said Garthwaite, director of the Program on Healthcare at the Kellogg School of Management at Northwestern University.
"They make money, now that they are owned by an insurance company ... when you use less health care," Garthwaite explained.
But despite being owned by an insurer, the company says it will remain agnostic toward insurers that reimburse it for services.
CVS sees growth opportunity in Oak Street, which has already been able to scale to 169 clinics and is expected to reach 300 by 2026. CVS benefits from the transaction as it can contribute to Oak Street patient growth through its channels, as well as driving greater utilization of CVS pharmacy and Caremark, according to CFO Shawn Guertin during a recent earnings call.
"There's obviously things we can do for plan design offerings to highlight the Oak network or the Oak clinics. We can do that with the Aetna members. I mentioned Signify before as a potential sort of source of members, but when you just think about the vast array of members that we interact with and the vast array of seniors that we interact with every year, across this company, this is a much wider catch basin if you will for potential growth," Guertin said.
Analysts have hailed the move, even while criticizing the price tag.
David Larsen, an analyst at BTIG, said in a note that this new primary care business, along with its recent acquisition of Signify, makes CVS "one of the most dominant forces in health care services."
Larsen noted that while the transaction has been talked about for a while — CVS said it had been doing due diligence for 15 months prior — he was "somewhat surprised at the pace with which the market is moving" with regard to primary care acquisitions.
Cigna (CI) and Walgreens (WBA) recently invested in VillageMD, and Walgreens is acquiring Summit Health for $8.9 billion, while Amazon (AMZN) acquired One Medical (ONEM).
Scott Dunn, lead healthcare analyst at CB Insights said major health-care brands like CVS are no longer simply insurers or drug store chains.
"These moves demonstrate the continued push by many high-profile pharmacies into fast-growing healthcare markets such as senior care, primary care, and home health," Dunn said in a recent note.
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InMode - >>> Better Medtech Stock to Buy: InMode or Outset Medical?
Motley Fool
By Keith Speights
Feb 15, 2023
https://www.fool.com/investing/2023/02/15/better-medtech-stock-to-buy-inmode-or-outset-medic/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
KEY POINTS
Both InMode and Outset Medical have solid growth prospects.
The main knock against Outset is that it isn't profitable yet, while InMode already generates strong profits.
The better medtech stock to buy could depend on your investing time horizon.
Sometimes the best opportunities are found in the laggards. Take medical technology (or medtech) stocks, for example. As a group, medtech stocks haven't performed well over the last year. However, their long-term potential should be great.
Two underperforming medtech stocks especially stand out. Both InMode (INMD 0.78%) and Outset Medical (OM -1.71%) reported their fourth-quarter results this week.
Which is the better medtech stock to buy? Here's how InMode and Outset stack up against each other.
Growth prospects
InMode is an Israel-based company that makes radio-frequency (RF) energy technology used for face and body contouring, medical aesthetics, and women's health. Outset Medical is a California-based company that makes hemodialysis systems. The growth prospects for both companies appear to be strong.
On Tuesday, InMode reported record revenue of $133.6 million in the fourth quarter of 2022, up 21% year over year. It also achieved record adjusted earnings of $66.4 million. The company projects full-year 2023 revenue of between $525 million and $530 million. The midpoint of this range reflects 16% growth.
Wall Street thinks that InMode will be able to deliver average annual earnings growth of 33% over the next five years. Unsurprisingly, analysts are bullish about the stock, with the average 12-month price target reflecting an upside potential of nearly 40%.
Outset Medical announced its Q4 results after the market closed on Monday. The company's revenue jumped 15% year over year to $32 million. However, Outset remains unprofitable, posting a Q4 net loss of $41.4 million.
The company expects to increase its revenue by 22% to 30% in 2023. Over the longer term, Outset hopes to capture a big chunk of the U.S. total addressable market of $11.4 billion. The majority of this market is in home dialysis. Outset thinks that its Tablo system offers significant competitive advantages for home use.
Financial positions
InMode had a cash stockpile (including cash, cash equivalents, marketable securities, and short-term bank deposits) of $547.4 million at the end of 2022. The company should continue to be profitable. Therefore, it won't need to tap its cash to fund ongoing operations.
Outset Medical's cash position totaled $290.8 million as of Dec. 31, 2022. The company isn't likely to turn a profit in the near future, though. This means that Outset will use some of its cash to fund operations.
The good news is that management expects to burn less cash in 2023 than in 2022. Outset also has around $200 million that it can draw down with its term loan facilities.
Valuation
InMode's shares currently trade at 13.2 times expected earnings and nearly 6.9 times trailing-12-month sales. The stock's price-to-earnings-to-growth (PEG) ratio is 2.9. This level indicates a relatively high valuation based on growth projections.
Because Outset Medical isn't profitable yet, earnings-based valuation metrics aren't applicable. However, the stock trades at nearly 12 times sales.
Better medtech stock?
So which of these two medtech stocks is the better pick right now? I think that InMode is more likely to beat the market in 2023 than Outset Medical is.
Analysts absolutely love the stock. Investors cheered InMode's Q4 update. Barring a severe recession, the stock should deliver solid returns this year.
Over the longer term, though, I suspect that Outset Medical will be the bigger winner. The company is currently only scratching the surface of its opportunity in the home dialysis market.
In my view, investors don't have to go with only "in" or "out." Both InMode and Outset are great picks.
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>>> Quipt Acquires $60 Million in Revenues and $13 Million Adjusted EBITDA with Strategic Acquisition of Great Elm Healthcare, LLC
Quipt Home Medical Corp.
January 3, 2023
https://finance.yahoo.com/news/quipt-acquires-60-million-revenues-213000813.html
Quipt Reaches $220 Million in Annualized Revenues and $49 Million of Anticipated Annualized Adjusted EBITDA
CINCINNATI, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Quipt Home Medical Corp. (“Quipt” or the “Company”) (NASDAQ:QIPT; TSXV:QIPT), a U.S. based home medical equipment provider, focused on end-to-end respiratory care, is very pleased to announce that it has acquired Great Elm Healthcare, LLC (“Great Elm”), a division of Great Elm Group, Inc. (NASDAQ:GEG) (the “Acquisition”), with an effective date of December 31, 2022. Great Elm operates a complete line of respiratory related durable medical equipment service locations across eight states in the Midwest, Southwest and Pacific Northwest. Based on an independent quality of earnings report, Great Elm had unaudited revenues for the 12 months ended August 31, 2022 of $60 million ?with an Adjusted EBITDA (defined below) of $13 million. As a reminder, all figures stated are in USD.
Transaction Highlights
Establishes Quipt as a leading respiratory-focused home medical equipment suppliers in the United States with significant scale, serving 270,000 patients with 32,500 referring physicians across 115 locations in 26 states.
The combination of Quipt and Great Elm has a combined Annualized Revenue (defined below) and Annualized Adjusted EBITDA (defined below) of $220 million and $47 million, respectively, based on Quipt’s reported audited results for the fourth quarter ended September 30, 2022 and Great Elm’s unaudited results for the 12 months ended August 31, 2022.
Pursuant to the membership interest purchase agreement dated January 3, 2022, the total purchase price is $80 million (subject to customary adjustments of Great Elm’s working capital, existing debt and expenses), comprised of $73 million in cash, $5 million in assumed debt, and 431,996 Quipt common shares at a deemed price per share equal to $4.63, representing a purchase price of 6.0x Adjusted EBITDA pre cost savings and synergies.
Quipt has identified $2 million in cost savings and synergies, which is expected to be captured over the first six months and is expected to result in Great Elm’s Anticipated Annualized Adjusted EBITDA (defined below) of $15 million, representing a purchase price of 5.2x Adjusted EBITDA post cost savings and synergies. The Anticipated Annualized Adjusted EBITDA is $49 million for Quipt.
Post-Acquisition, Quipt’s Recurring Revenue (defined below) are expected to increase from 77% for the fiscal year ended September 30, 2022, to 82%, on a pro forma basis.
Quipt to drawdown a total of $73 million from its $110 million senior secured credit facility (announced on September 19, 2022), maintaining a conservative balance sheet with net debt to Adjusted EBITDA of 1.96x on a pro forma basis.
Expected to be financially accretive to overall growth and cash flow.
Adds tremendous cross-selling opportunities in which Quipt may sell products in Great Elm locations, including ventilation and oxygen.
Adds significant opportunity to increase resupply revenue and margins once Great Elm’s sleep patients are onboarded to Quipt’s resupply program.
Great Elm's footprint is expected to create additional opportunities to expand Quipt’s access for accretive tuck-in acquisitions.
The combination of two leading clinical respiratory providers is expected to enhance Quipt’s patient-centric ecosystem across the entire company by further collaborating with key sales touchpoints, including healthcare providers like hospitals, doctors, rehab centres, and long-term care facilities.
With this Acquisition Quipt successfully surpasses its previously announced outlook of achieving Annualized ?Revenue by the end of calendar 2022 (Q1 2023) of $180-$190 million.?
Acquisition Commentary
Great Elm is a leading operator of respiratory related durable medical equipment service with 21 locations across eight states in the Midwest, Southwest, and Pacific Northwest, adding seven new states to Quipt’s current geographic coverage including Arizona, Alaska, Iowa, Kansas, Nebraska, Oregon, and Washington. The combination of Great Elm and Quipt positions Quipt to become a national HME provider with near coast to coast operations. The Acquisition adds 8,500 referring physicians bringing Quipt’s referring network base to over 32,500, and increases Quipt’s active patient count by 70,000, bringing Quipt’s total to 270,000 active patients. As a result of Great Elm’s significantly weighted respiratory product mix, respiratory products will now make up approximately 79% of Quipt’s product mix. By opening new markets and fostering connections with referral partners, patients, and payors, Great Elm considerably increases the Company’s scale and geographic reach.
Great Elm represents a turnkey platform acquisition for Quipt as it dramatically enhances Quipt’s operations and provides the Company with significant additional inorganic and organic growth opportunities. The advanced infrastructure of Great Elm, which includes strong leadership and strong internal processes, is expected to significantly expedite the integration process, and will greatly complement Quipt’s existing infrastructure. The Acquisition will also allow Quipt to cross sell its products in Great Elm locations with the opportunity to significantly increase revenue associated with Quipt’s subscription-based resupply program through the onboarding of Great Elm patients. Quipt has identified $2 million in cost savings and synergies, which is expected to be captured over the first six months.
Great Elm is focused on clinical excellence, and like Quipt, offers a high-quality, full-service line of respiratory equipment, and supplies. Great Elm has a diversified payor mix and several difficult to obtain insurance contracts. Additionally, Great Elm’s operating footprint aligns closely with regions that have a high prevalence of Chronic Obstructive Pulmonary Disease (“COPD”), a key target patient group of Quipt. The eight states in which Great Elm operates includes over 1.5 million1 people suffering from COPD.
Management Commentary
“We are extremely thrilled to start 2023 with the milestone acquisition of Great Elm Healthcare, which gives us significant coast-to-coast presence across the United States and firmly establishes Quipt as one of the top clinical at-home respiratory providers in the nation. I would like to use this opportunity to extend a warm welcome from the Quipt family to the entire Great Elm team. We are eager to get started. Over 1.5 million people in the jurisdictions serviced by Great Elm suffer from COPD2, and this acquisition positions us to make progress in this primary target market,” said Greg Crawford, Chairman and CEO of Quipt. “Great Elm represents a true platform investment for Quipt and provides us with the opportunity to serve pulmonary and neurological disease states by utilizing the patient-centric ecosystem we have built focused on ventilation therapy, oxygen therapy and sleep therapy. This creates immediate and actionable revenue synergies for us. Moreover, the valuable commercial insurance contracts, strong referring physician network, and significant patient base we have accumulated across seven new states will give us the ability to cross sell our products into these new geographies. The highly skilled and seasoned leadership team at Great Elm bolsters our ability to further enhance organic growth and margin expansion across the combined organization when joined with our current executive team. On a combined basis, we expect to have Annualized Revenue of $220 million and Anticipated Annualized Adjusted EBITDA of $49 million on a pro forma basis, putting us in a formidable position to continue to capitalize on the opportunities in front of us as we continue to increase shareholder value.”
Chief Financial Officer, Hardik Mehta added, “Our prudent capital deployment strategy has once again yielded fantastic results. We wanted to focus on closing our largest deal first and the acquisition of Great Elm is a major accomplishment, providing us with a turnkey acquisition at a prudent purchase price while maintaining our conservative balance sheet and allowing for financial flexibility on a go forward basis. We fully expect to be able to expand our senior credit facilities when opportunities arise, and we will continue to leverage technology and data driven decision-making to unlock additional profitability and to ensure we continue to improve upon our patient centric ecosystem. We look forward to a seamless integration process and believe the increased geography of our business will allow us to create additional opportunities to further expand on our proven acquisition and integration approach with highly accretive tuck-in acquisitions for our full suite of respiratory care products and services. The Great Elm acquisition is a fantastic way to start the new year and we look forward to keeping investors apprised of our continued success.”
The Company will post updated corporate slides at www.quipthomemedical.com.
ABOUT QUIPT HOME MEDICAL CORP.
The Company provides in-home monitoring and disease management services including end-to-end respiratory solutions for patients in the United States healthcare market. It seeks to continue to expand its offerings to include the management of several chronic disease states focusing on patients with heart or pulmonary disease, sleep disorders, reduced mobility, and other chronic health conditions. The primary business objective of the Company is to create shareholder value by offering a broader range of services to patients in need of in-home monitoring and chronic disease management. The Company’s organic growth strategy is to increase annual revenue per patient by offering multiple services to the same patient, consolidating the patient’s services, and making life easier for the patient.
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Qiagen - >>> Strong core growth offsets dwindling COVID-19 demand for Qiagen
Reuters
February 7, 2023
https://finance.yahoo.com/news/strong-core-growth-offsets-dwindling-210500265.html
BERLIN, Feb 7 (Reuters) - Medical diagnostics company Qiagen offset a sharp fall in demand for COVID-19 products at the end of the year with a strong performance in its core businesses, the company said, announcing its full-year and fourth quarter results on Tuesday.
Fourth quarter revenues came in at $498 million, a 14% fall compared with the same period last year. Revenues from COVID products fell 64% to $66 million, but this was offset by strong growth in non-COVID products, where revenues rose 8% to $432 million.
For 2023, the molecular diagnostics test maker expects revenues of $2.05 billion, compared with $2.14 billion for 2022, and an adjusted profit per share of $2.10.
"We have positioned Qiagen well to successfully navigate 2023's volatile macroeconomic environment," said Chief Executive Thierry Bernard.
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InMode - >>> How IBD Stock Of The Day InMode Is Smoothing Out The Wrinkles
Investor's Business Daily
by ALLISON GATLIN
02/03/2023
https://www.investors.com/research/ibd-stock-of-the-day/inmd-stock-glows-up-as-medical-aesthetics-boom/?src=A00220
IBD Stock Analysis
Shares currently in a consolidation with a buy point of 40.39
Stock surged above its 50-day moving average this week
Composite Rating is 91 out of possible 99; EPS Rating is 97
InMode (INMD) is Friday's IBD Stock Of The Day. The medical aesthetics company says it's shrugging off recessionary concerns and INMD stock is smoothing out the wrinkles.
The company recently pre-announced $133.2 million to $133.4 million in fourth-quarter sales, up 21% year over year. Shares dropped on the pre-announcement as it suggested a slowdown in growth from 29% in the three months ended Sept. 30.
Chief Executive Moshe Mizrahy says InMode is still growing. He noted the guidance for this year indicates sales will grow by roughly $75 million. Notably, that also suggests a slowdown.
"But the market knows that we are very conservative in guidance," he said during the Needham Growth Conference last month.
INMD stock is currently consolidating with a buy point at 40.39, according to MarketSmith.com. Shares surged above their 50-day moving average this week. The stock dropped 2.8% to close at 37.24 on the stock market today.
INMD Stock: Guidance Conservative
InMode's devices use radio frequency technology to tighten skin and kill fat cells. The procedures are minimally invasive, meaning they can be performed in a doctor's office.
During the fourth quarter, InMode's sales came in between $133.2 million to $133.4 million, the company said in its pre-announcement.
That leads to full-year sales of $453.9 million to $454.1 million. At the midpoint, sales would grow 27%. For 2023, InMode guided to $525 million to $530 million in sales, up 16%. That means sales growth over the last two years paled in comparison to a nearly 74% jump in 2021.
But Mizrahy says the guidance is conservative and InMode often outdoes itself. Needham analyst Mike Matson also noted the same. He sees the potential for new products launching this year could boost sales.
He has a buy rating and 60 price target on INMD stock. The company will officially report its fourth-quarter earnings on Feb. 14.
Medical Aesthetics Strong
Medical aesthetic sales don't seem to be slowing. The IBD 50 is headed up by Revance Therapeutics (RVNC), a maker of skin-tightening and facial-filling shots.
But InMode also sees an opportunity to carve a new market in women's health. It's testing a system called EmpowerRF in 15 clinical studies. Today, the system treats weak pelvic floor muscles, works to improve blood circulation, remodels tissue and strengthens abdominal muscles.
But Chief Medical Officer Spero Theodorou notes the same system is capable of running aesthetic procedures. Gynecologists treating weak pelvic floor muscles or overactive bladder could also sell their patients on aesthetic procedures. The latter is where the "big money is," he said.
Next, InMode hopes to do the same with its EnvisionRF system for dry eye treatment.
Promisingly, INMD stock has a strong Composite Rating of 91. This puts shares in the top 9% of all stocks when it comes to fundamental and technical measures, according to IBD Digital. Shares have an even stronger EPS Rating of 97 out of 99, a measure of profitability. It's also on the IBD Tech Leaders list.
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>>> Your Blood Type Affects Your Risk of Early Stroke, Scientists Find
Science Alert
by Felicity Nelson
https://www.msn.com/en-us/health/medical/your-blood-type-affects-your-risk-of-early-stroke-scientists-find/ar-AA17eygY?cvid=7b4dff7837ad4ddba099c178b0bbd94b
People with one of the type A blood groups are more likely to have a stroke before the age of 60 compared with people with other blood types, research shows.
Blood types describe the rich variety of chemicals displayed on the surface of our red blood cells. Among the most familiar are those named A and B, which can be present together as AB, individually as A or B, or not present at all, as O.
Even within these major blood types, there are subtle variations arising from mutations in the genes responsible.
In a study published last year, genomics researchers uncovered a clear relationship between the gene for the A1 subgroup and early onset stroke.
Researchers compiled data from 48 genetic studies, which included roughly 17,000 people with a stroke and nearly 600,000 non-stroke controls. All participants were between 18 and 59 years of age.
A genome-wide search revealed two locations strongly associated with an earlier risk of stroke. One coincided with the spot where genes for blood type sit.
A second analysis of specific types of blood-type gene then found people whose genome coded for a variation of the A group had a 16 percent higher chance of a stroke before the age 60, compared with a population of other blood types.
For those with a gene for group O1, the risk was lower by 12 percent.
The researchers noted, however, that the additional risk of stroke in people with type A blood is small, so there is no need for extra vigilance or screening in this group.
"We still don't know why blood type A would confer a higher risk," said senior author and vascular neurologist Steven Kittner from the University of Maryland.
"But it likely has something to do with blood-clotting factors like platelets and cells that line the blood vessels as well as other circulating proteins, all of which play a role in the development of blood clots."
While the study findings may seem alarming – that blood type could change early stroke risk – let's put these results into context.
Each year in the US just under 800,000 individuals experience a stroke. Most of these events – around three out of every four – occur in people 65 years and older, with risks doubling every decade after the age of 55.
Also, the people included in the study lived in North America, Europe, Japan, Pakistan, and Australia, with people of non-European ancestry only making up 35 percent of participants. Future studies with a more diverse sample could help clarify the significance of the results.
"We clearly need more follow-up studies to clarify the mechanisms of increased stroke risk," Kittner said.
Another key finding of the study came from comparing people who had a stroke before the age of 60 to those that had a stroke after the age of 60.
For this, the researchers used a dataset of about 9,300 people over the age of 60 who had a stroke, and some 25,000 controls over the age of 60 who didn't have a stroke.
They found that the increased risk of stroke in the type A blood group became insignificant in the late-onset stroke group, suggesting that strokes that happen early in life may have a different mechanism compared to those that occur later on.
Strokes in younger people are less likely to be caused by a build-up of fatty deposits in the arteries (a process called atherosclerosis) and more likely to be caused by factors to do with clot formation, the authors said.
The study also found that people with type B blood were around 11 percent more likely to have a stroke compared to non-stroke controls regardless of their age.
Previous studies suggest that the part of the genome that codes for blood type, called the 'ABO locus', is associated with coronary artery calcification, which restricts blood flow, and heart attack.
The genetic sequence for A and B blood types have also been associated with a slightly higher risk of blood clots in veins, called venous thrombosis.
This paper was published in Neurology.
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>>> InMode - Steady State Revenue In Sight
Feb 05, 2023
Seeking Alpha
by Evan Rodick
https://seekingalpha.com/article/4575491-inmode-stock-steady-state-revenue-fairly-valued
InMode Ltd. is filling a treatment gap in the market with innovative, minimally invasive cosmetic procedure technologies.
Most of InMode’s revenue comes from growing adoption of devices. Soon, though, sales will be primarily to update its installed unit base as growth steadies.
For my base case, I estimate an installed unit base of around 17,000 and 2023 revenue of around $434M, not far from current numbers.
In my downside case, the stock is already at fair value, and I recommend a “Hold” rating, though there is high potential in the upside case.
Investment Thesis
The technologies InMode Ltd. (NASDAQ:INMD) develops fill a gap in the cosmetic surgery market between laser procedures and plastic surgery. This has driven growing adoption of the company’s devices. I believe the company’s capital revenue will likely start to reach a steady-state within the next couple of years as adoption slows. Depending on market share and device lifespan assumptions, the picture could change quite a bit. Read on to see what I project in my base case, downside case, and upside case for InMode’s future.
The Unmet Need and the Product Portfolio
InMode Ltd. sells technology and machines across the globe for performing minimally invasive cosmetic procedures. It offers technologies for face contouring, body contouring and remodeling, women’s wellness, and hair removal. As can be seen below in the slide from the latest investor presentation, InMode seeks to innovate in a space between two traditional types of treatments. On one end, plastic surgery (including liposuction) can require long recovery and high expenses. Laser procedures on the other end of the spectrum are totally non-invasive but they can only treat a limited set of cases. This leaves a “treatment gap” in the middle, which has already proven to be ripe with opportunities for the company.
InMode covers this in-between space with a range of equipment, outlined in the table below. 84% of the company’s revenue comes from “minimally invasive” Surgical/RFAL and SARD devices (all references to InMode’s current financials come from the 3rd quarter financial results), though the company also offers traditional non-invasive laser devices.
In the nine months ended September 30th, 2022, InMode made $180,640,000 of revenue in the U.S. selling equipment, which was 25% more than what it made in the same period the year prior. Capital equipment revenue was by far the majority of the company’s revenue; consumables and service revenues were only 13% of total revenue. Over the course of the year from Q3 2021 to Q3 2022, the unit installed base in the U.S. increased from 5,150 to 7,260. From these numbers, it can be assumed that the price for these units is in the order of $100,000 each. Indeed, I found one EmbraceRF listed online for $89,999.
Competition and Market Share
InMode is quite innovative in minimally invasive body and face sculpting and remodeling. However, people still have options. If patients are not willing to go forward with full-on plastic surgery, they could go for a non-invasive fat reduction technology such as Coolsculpting™, Liposonix™, Emsculpt™, Vanquish™, or Zerona™. Likewise, they could opt for non-surgical skin tightening such as Pelleve™, Thermage™, Ulthera™.
From this competitive landscape, I can begin to build a picture of what InMode’s steady-state market share could look like. InMode estimates there are more than 100,000 surgically-trained physicians in the U.S and more than 200,000 globally. A broken stick model shows what market shares could look like with 10 major players.
On the high end of this ranking, the #1 player would have 29% market share while on the low end, the #10 player would have only 1% market share. If InMode is somewhere in the middle of the pack (i.e., 5th in the market), then that would give InMode about an 8.5% market share. If each physician that buys from InMode only buys one unit, that works out to be about 17,000 units installed worldwide, not far off from the current installed base of 15,480 units. This may be on the lower end of the range given that the company grew its installed base over 5,000 units from 10,350 units in just one year. However, using 17,000 units as a starting point, it would be helpful next to dig in further into what this could mean for revenues.
Base Case Valuation
To understand InMode’s future, it is necessary to estimate revenues from the two sources of revenue for the company: capital revenue and consumables and services revenue.
For capital revenue–that is, revenue from sales of new devices–my expectation is that InMode will reach its entitled market share sooner rather than later. At that point, most of its capital revenue will come from replacing old equipment rather than new adoption, so I needed to assume a device lifespan to analyze what the capital revenue could be. There is no direct data on equipment lifespan for InMode that I could find, but given that most of the attachments are consumables, the heart of the machine could be thought of as similar to a desktop computer, which typically lasts five to eight years. For this analysis, I assumed five years. Continuing to assume an installed unit base of 17,000, this results in about 3400 units being sold per year, amounting to ~$340M in capital revenue at $100k per unit.
Consumables and service revenues would become a higher percentage of InMode’s total revenue as capital revenue growth slows. One way to estimate this revenue is to look at 2022’s consumables and services revenue compared to 2021’s installed unit base. I figured that the $42,934,000 of consumables and services revenue in the nine months ending September 30th 2022 came primarily from the prior year’s installed unit base of 10,350 units. That works out to be a little over $5500 in revenue per installed unit per year. At a steady state of 17,000 units, that would result in about $94 million in consumables and service revenue, and a total revenue of $434M, which is a little bit less than the $454M that InMode is estimating for 2022.
Though this would be a steady-scenario, InMode should also benefit from a growing market. One piece of research estimates a CAGR for the minimally invasive surgery market more broadly as 4.7% from 2021-2030. After that, I assumed the market would continue to grow at the average historical ~3% GDP growth-rate into the future.
The company has become relatively consistent in turning revenue into earnings with net margins around 40%.
Taking all of this together, I was able to forecast earnings per share to produce a base case valuation. I discounted those projected earnings over 50 years with the average real stock market rate of return of 7%. The full details are presented in the table below.
Summing up, the discounted EPS gives a valuation of $52.40. With a stock price of around $37 at the time of writing, that is a margin of safety of 30%, which is not bad, but there are some big assumptions in this model. I would either want more confidence in these projections or a larger margin of safety to be able to recommend a buy.
Downside and Upside Cases
On the downside, one of the assumptions I considered is the lifespan of the units. If instead of needing to be replaced every 5 years they only need to be replaced every 8 years, that changes capital revenue considerably from $340M to $212M–an almost 40% drop.
This is not the only downside consideration. Further competition, especially from new innovation, could eat at InMode’s market share potential. I also recognize that the estimate of unit revenue from consumables and services could be off, which has large implications as consumables and services become a larger percentage of total revenue.
On the upside, however, one of the big assumptions is the market share. For instance, just going up one place on the broken stick model changes the market share from 8.5% to 11%.
These projections put the company in a fairly good position and indicate that on the low side InMode is near fair value, but on the high side has a lot of potential. Showing these various cases, however, reveals how sensitive the projections are to key assumptions and bolsters my view that a larger margin of safety would be desirable.
Financials and Other Considerations
Several financial metrics help build a positive impression of the company. Insider holdings remain high at 16.75%. The company also has very little debt. The non-current debt is $12,754,000 while the shareholder equity is $508,303,000, which results in a very low long-term debt-to-equity ratio of only 0.025. Indeed, InMode could easily pay its total liabilities of $70,681,000 with its $77,048,000 in cash, putting it in a very strong financial position.
Additionally, InMode has opportunities to further innovate and to acquire business in adjacent spaces. As CEO Moshe Mizrahy stated: “In addition to our active pipeline of new technology, we're also exploring potential acquisition that could complement our presence in the wellness market.” These options could provide more growth to come on top of the steady-state cases I presented above.
Conclusion
InMode's product portfolio covers the gap between traditional plastic surgery and non-invasive laser procedures, which has proven to be a lucrative market opportunity. InMode has made significant growth in revenue and increased its unit installed base over the past few years. Eventually, though, it will totally fill its current niche and capital revenue will begin to rely on broader market growth and unit replacement rather than growth in device adoption. Based on some key assumptions, I detailed three different cases that should provide investors some confidence that InMode is at least near fair value. There is too much uncertainty in these projections and not enough margin of safety to be able to recommend a buy from my point of view. However, the downside appears to be much smaller than the upside, so I recommend a “Hold” rating. Investors who feel more optimistic about an upside case based on their own research may be interested in buying. Through market growth, innovation, and acquisitions, there are plenty of ways for this company to succeed.
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InMode - >>> 3 Reasons Wall Street Thinks InMode Can Rocket 47% Higher in 2023
Motley Fool
By Cory Renauer
Jan 27, 2023
https://www.fool.com/investing/2023/01/27/3-reasons-wall-street-thinks-inmode-can-rocket-47/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
KEY POINTS
InMode is a medical device maker that specializes in minimally invasive treatments with results that resemble those of liposuction.
The average price target on Wall Street for InMode represents a 47% upside.
Analysts' price targets for this stock suggest it could soon put up some big gains.
Individual investors who want help picking stocks have more than a few options to choose from, including the recommendations of Wall Street analysts. Right now, InMode (INMD 0.25%) is a medical technology stock that analysts on Wall Street can't seem to get enough of. Among those who follow InMode, the average analyst is targeting a 47% gain for the stock over the next year.
Analysts usually have considerably more resources to work with than the average retail investor. That said, you shouldn't choose stocks for your portfolio based entirely on their eye-popping price targets. Let's examine three of the reasons analysts are pounding the table for InM0ode stock to see if it deserves a spot in your portfolio.
1. InMode's share of the market for cosmetic procedures is growing
InMode develops and markets a wide range of proprietary medical devices that cosmetic surgeons can use to shape body fat and smooth out wrinkled skin. With a narrow probe inserted under the skin, the company's BodyTite device produces results similar to those of liposuction, but without any incisions.
BodyTite and other subdermal ablative treatments are responsible for around four-fifths of the company's total revenue. It also markets hands-free devices, such as Evoke, that rest on the face during treatment without ever puncturing the skin.
Despite providing a temporary solution to wrinkles, cosmetic Botox injections generate more than $2.5 billion in sales annually for AbbVie. BodyTite and similar products, with their ability to permanently alter a person's fat composition, are raising InMode's share of the market for non-invasive procedures. In the third quarter of 2022, cosmetic Botox sales rose 17% year over year, while InMode's sales rose 29%.
In the U.S. alone, the market for non-invasive cosmetic procedures reached $16.4 billion in 2021, and it's expected to grow at a 14% annual rate through 2030, according to Grand View Research. In 2022, InMode racked up about $454 million in worldwide sales, suggesting there's a lot of room for its business to grow.
2. A razor-and-blades business model
There are only so many practicing providers of cosmetic procedures, and it's just a matter of time before most operations that could make use of InMode's workstations already have one installed. Analysts with an eye on the long term are drawn to InMode because it employs a razor-and-blades business model.
In addition to earning money on initial sales of its workstations, InMode sells the consumable goods that those devices use, which need to be replaced before each procedure, and services its machines. In the third quarter, revenues from services and consumables shot up 53% year over year.
Rapidly growing consumable sales suggest InMode's products are increasingly popular among both patients and providers. Over the long run, consumables sales could allow the company to continue growing long after its workstations become ubiquitous.
3. InMode stock looks like a bargain
One of the biggest reasons Wall Street expectations suggest big gains could be around the corner is InMode's relatively low valuation. The stock trades for just 14.3 times management's adjusted earnings estimate for 2022. By comparison, the average stock in the benchmark S&P 500 index trades at 18.9 times trailing earnings.
InMode is already the go-to provider of fat-melting subdermal ablative devices, and its proprietary technology gives the company a good chance of maintaining its lucrative position over the long run. Put it all together, and you'll see why this stock is a screaming buy right now.
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>>> InMode Ltd. (INMD) designs, develops, manufactures, and markets minimally invasive aesthetic medical products based on its proprietary radiofrequency assisted lipolysis and deep subdermal fractional radiofrequency technologies in the United States and internationally. The company offers minimally invasive aesthetic medical products for various procedures, such as liposuction with simultaneous skin tightening, body and face contouring, and ablative skin rejuvenation treatments, as well as for use in women's health conditions and procedures. It also designs, develops, manufactures, and markets non-invasive medical aesthetic products that target an array of procedures, including permanent hair reduction, facial skin rejuvenation, wrinkle reduction, cellulite treatment, skin appearance and texture, and superficial benign vascular and pigmented lesions, as well as hands-free medical aesthetic products that target a range of procedures, such as skin tightening, fat reduction, and muscle stimulation. The company was formerly known as Invasix Ltd. and changed its name to InMode Ltd. in November 2017. InMode Ltd. was incorporated in 2008 and is headquartered in Yokneam, Israel.
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>>> Danaher Takes Interest in Life Sciences Firm Catalent
Danaher’s overtures in recent months may not lead to a deal
New Jersey-based Catalent has market value of $10 billion
Bloomberg
By Liana Baker, Michelle F Davis and Ed Hammond
February 4, 2023
https://www.bloomberg.com/news/articles/2023-02-04/danaher-is-said-to-be-interested-in-life-sciences-firm-catalent
Life sciences company Danaher Corp. has expressed takeover interest in contract manufacturer Catalent Inc., according to people familiar with the matter.
The overtures by Danaher in recent months valued Catalent at a significant premium, the people said, asking not to be identified because the matter is private. It’s unclear how Catalent will proceed or whether it’s receptive to a takeover offer, the people said. A deal isn’t imminent, they added.
“As a matter of company policy, Catalent does not comment on market rumors or speculation,” a representative said in an emailed statement.
A representative for Danaher didn’t immediately respond to a request for comment.
Catalent, based in Somerset, New Jersey provides delivery technologies and development solutions for drugs, biologics and consumer health products. The manufacturer has gained prominence during the coronavirus pandemic, helping to produce more than a billion Covid-19 vaccines and treatments in partnership with companies including Moderna Inc., Johnson & Johnson and AstraZeneca Plc.
The company’s shares more than tripled in the first year of the pandemic but have fallen about 60% since their peak in September 2021. They closed at $56.05 on Friday, giving the company a market value of about $10 billion.
Danaher has become a life sciences focused company since spinning out its industrial business arm Fortive Corp. in 2016.
Shares of the Washington-based company closed at $269.85 Friday, giving it a market value of more than $196 billion.
While Danaher is known in the industry as a serial acquirer, it hasn’t announced any major deals since 2021, when it bought Aldevron, a maker of proteins used in vaccines and research, for $9.6 billion.
A deal uniting Danaher and Catalent would be one of the largest transactions this year, in what’s been a sleepy market for dealmaking.
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VEXAS Syndrome - >>> Tens of Thousands of Americans May Have This Deadly Disease—and Not Even Know It
Daily Beast
by Maddie Bender
January 24, 2023
https://www.yahoo.com/news/tens-thousands-americans-may-deadly-212831922.html
The patient, Hector Campos, came into the emergency department with shortness of breath, erratic fever, and swollen, itchy ears. His wife explained that Campos had tested negative for COVID-19. “What do you think this might be?” Campos asked the chief of emergency medicine, Ethan Choi, who was similarly befuddled by the man’s symptoms.
Scary, right? But it’s not real—Campos and Choi are both characters on the NBC medical drama Chicago Med. Over the course of the episode, which aired in March 2021, Choi initially misdiagnoses Campos’ symptoms as pneumonia and a bacterial infection, but a test comes back for widespread inflammation. Campos’ condition rapidly deteriorates, and the team of doctors is miffed until fellow ER surgeon Dean Archer suggests it might be VEXAS, a rare autoinflammatory syndrome. Genetic sequencing ultimately finds a mutation confirming the diagnosis, and Choi begins treating the patient.
The episode is fictional, but depictions like this one are surprisingly accurate to real-life cases of VEXAS, said David Beck, a clinical genetics researcher at New York University Grossman School of Medicine. “In terms of clinical manifestations,” he told The Daily Beast, “they’ve been spot on.” Beck ought to know: He and his colleagues first named the syndrome in a study published in The New England Journal of Medicine in 2020. “I’ve been impressed, actually, with depictions in popular media, because [it shows] they’ve read the paper.”
Even so, these representations of VEXAS syndrome tend to highlight severe cases, in part because the NEJM paper did, too. Of the 25 cases the researchers studied, 10 of the patients died from VEXAS-related causes.
But more recent research has expanded the case definition of VEXAS to include a milder side. In a paper published in JAMA on Jan. 24, Beck and his colleagues scanned genetic sequencing readings from more than 160,000 people to determine how common VEXAS syndrome really is, and how its symptoms manifest in patients. The research team found that nine male patients and two female patients in their study had mutations that caused VEXAS.
And as a result, the researchers estimated that the syndrome affects about 13,200 men and 2,300 women over age 50 in the U.S. alone.
“It’s thrilling to go from trying to understand a few patients to finding that the same genetic cause and the same disease is found in tens of thousands of individuals,” Beck said. “Not just because we know that there are many patients out there who are suffering, who don't get a diagnosis, or who don't get the treatment that can help them and just taking a step in that direction; it's also very surprising that you can still make these sort of discoveries despite all of the biomedical research going on.”
VEXAS is an acronym that stands for several key features of the syndrome. In every case of the syndrome, a patient has a genetic mutation coding for the enzyme E1. The mutation occurs on a gene on the X chromosome, which as you might recall from biology class, is a sex chromosome—men only have one, making them more prone to coming down with VEXAS. And the mutation is somatic, which means it is acquired during life as opposed to being inherited from a parent. That last feature, which gives VEXAS its “S,” is crucial: Because VEXAS is caused by a somatic mutation, the syndrome isn’t passed down and only occurs in older patients, typically over the age of 50, Beck said.
This type of research, Beck emphasized, has been made possible by recent advances in genetic sequencing that make it readily available and affordable to patients. The participants in the study all sought care at a Geisinger health care facility in central and northeastern Pennsylvania between 1996 and 2022. As part of a collaboration between Geisinger and the Regeneron Genetics Center to map genetic variation across the human genome, the participants’ exomes—regions of their genomes that encode proteins—were sequenced.
All of the 11 participants found to have mutations in the gene for the E1 enzyme were anemic and the vast majority had abnormally large red blood cells and a low platelet count—all symptoms consistent with VEXAS syndrome. Importantly, though, some of the more severe symptoms associated with VEXAS, like inflammation in the cartilage (which caused Campos’ swollen ears), were not present in these patients. This suggests that there may be a broader spectrum of severity when it comes to cases of VEXAS syndrome.
One other puzzling aspect of the study was the fact that the two women retrospectively identified as having VEXAS syndrome only suffered from the VEXAS-related mutation on one of their X chromosomes, not both. “It’s confusing for us,” since originally the researchers thought that VEXAS only affected men, Beck said. “We've been slowly recognizing more females that have the disease, and we don't understand why that is.” One phenomenon at play could be X-inactivation, a process in which one of a female’s two X chromosomes is silenced throughout their cells.
The researchers wrote in the study that future analyses will be critical to understanding the prevalence of the syndrome in diverse populations, since 94 percent of the participants in the Geisinger cohort were white.
Currently, there are no treatments for VEXAS approved by the Food and Drug Administration, but a phase II clinical trial is underway to study whether blood stem cell transplants can treat or cure the syndrome. In 2022, a team of French researchers published a study suggesting that such a transplant can lead to complete remission, but such a procedure is not without its risks.
On the research side, Beck said that scientists are still trying to figure out how a mutation in the gene that encodes E1 leads to the widespread inflammation seen in cases of VEXAS. This enzyme starts a process for a cell to eliminate proteins it no longer needs, and further research is ongoing to determine how a dysfunctional E1 enzyme impacts this process.
“If you're an older individual with systemic inflammation, low blood counts, don’t have any clear diagnosis, and you require steroids but don't have any clear diagnosis,” you should contact your doctor about genetic testing for VEXAS syndrome, Beck said.
“It may help lead to better treatments for you—and at least a clear diagnosis,” he said.
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>>> New COVID Variants Are Escaping the Immune System. Here’s What That Means.
Daily Beast
by Maddie Bender
January 18, 2023
https://www.yahoo.com/news/covid-variants-escaping-immune-system-224350409.html
BA.5, BQ.1.1, and XBB? It’s no wonder people are struggling to keep all the circulating variants of COVID-19 straight right now. Whether you want to call them “alphabet soup,” “Scrabble,” or “Kraken,” we’ve been reminded time and again that it’s not the name of the subvariant that matters, but rather the way it interacts with our immune systems. And as we enter into our fourth year with COVID-19, scientists are most concerned with how well prior infections, vaccinations, and boosters can protect us against emerging variants of the virus.
The answers are starting to roll in—and they’re not looking great for us. In a letter published on Jan. 18 in The New England Journal of Medicine, researchers from Beth Israel Deaconess Medical Center and Los Alamos National Laboratory detail the nasty abilities of variants BQ.1.1 and XBB.1 to escape incapacitation from COVID-specific antibodies. This is cause for concern because as the authors wrote, these variants “may reduce the efficacy of current mRNA vaccines.”
Before Aug. 31 in the U.S., available COVID-19 boosters were monovalent, meaning they contained viral genetic material from one strain of the virus. The updated boosters are bivalent and were created with genetic material from the original COVID-19 strain as well as Omicron variant strains with the hope of offering better protection against new and emerging variants.
COVID’s New Year’s Resolution Is to Infect Us All Again (and Again)
Unfortunately, these early data seem to show that two of the newest variants can dodge even the bivalent boosters. In their study, the researchers took serum samples from 16 people who received a monovalent booster in 2021, 15 who received a monovalent booster in 2022, and 18 people who received a bivalent booster in September 2022. In all three cohorts, the concentration of neutralizing antibodies—which immobilize copies of the virus and prevent them from infecting cells—fighting the original Wuhan strain shot up after participants received boosters, from the hundreds or thousands to the tens of thousands.
But their immune response against some of the newest viral variants was severely diminished, even compared to ones that came directly before. The authors found that neutralizing antibody concentrations to variants BQ.1.1 and XBB.1 were between 53 and 232 times lower than those to the original strain of COVID-19, depending on the booster received. These variants were even better than a recent Omicron variant at evading the immune system and escaping neutralizing antibodies.
On Jan. 11, the World Health Organization released a risk assessment about XBB.1.5, writing that BQ and XBB variants are “the most antibody-resistant variants to date” but cautioning that “[t]here is currently no data on real world vaccine effectiveness against severe disease or death” for these variants.
It’s clear that these variants aren’t good news, but future research is needed to suss out just how bad they will turn out to be. This study is one early indication that as sick as we might be of the COVID-19 pandemic, we aren’t out of the woods just yet.
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Gundry - >>> MRNA COVID vaccines dramatically increase endothelial inflammatory markers and ACS risk as measured by the PULS cardiac test: A warning
Gundry, S. R..
Circulation ; 144(SUPPL 1), 2021.
Artigo em Inglês | EMBASE | ID: covidwho-1632901
ABSTRACT
Our group has been using the PLUS Cardiac Test (GD Biosciences, Inc, Irvine, CA) a clinically validated measurement of multiple protein biomarkers which generates a score predicting the 5 yr risk (percentage chance) of a new Acute Coronary Syndrome (ACS). The score is based on changes from the norm of multiple protein biomarkers including IL-16, a proinflammatory cytokine, soluble Fas, an inducer of apoptosis, and Hepatocyte Growth Factor (HGF)which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue, among other markers. Elevation above the norm increases the PULS score, while decreases below the norm lowers the PULS score. The score has been measured every 3-6 months in our patient population for 8 years. Recently, with the advent of the mRNA COVID 19 vaccines (vac) by Moderna and Pfizer, dramatic changes in the PULS score became apparent in most patients. This report summarizes those results. A total of 566 pts, aged 28 to 97, MF ratio 11 seen in a preventive cardiology practice had a new PULS test drawn from 2 to 10 weeks following the 2 COVID shot and was compared to the previous PULS score drawn 3 to 5 months previously pre- shot.
Baseline IL-16 increased from 35=/-20 above the norm to 82 =/- 75 above the norm post-vac;sFas increased from 22+/- 15 above the norm to 46=/-24 above the norm post-vac;HGF increased from 42+/-12 above the norm to 86+/-31 above the norm post-vac.
These changes resulted in an increase of the PULS score from 11% 5 yr ACS risk to 25% 5 yr ACS risk. At the time of this report, these changes persist for at least 2.5 months post second dose of vac.
We conclude that the mRNA vacs dramatically increase inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination.
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>>> Changes of ECG parameters after BNT162b2 vaccine in the senior high school students
https://pubmed.ncbi.nlm.nih.gov/36602621/
Eur J Pediatr
. 2023 Jan 5;1-8. doi: 10.1007/s00431-022-04786-0. Online ahead of print.
Changes of ECG parameters after BNT162b2 vaccine in the senior high school students
Shuenn-Nan Chiu 1, Yih-Sharng Chen 2, Chia-Chen Hsu 3 4 5, Yu-Chuan Hua 6, Wei-Chieh Tseng 1 7, Chun-Wei Lu 1, Ming-Tai Lin 1, Chun-An Chen 1, Mei-Hwan Wu 1, Yu-Ting Chen 8, Ting-Chou Hung Chien 8, Chien-Lun Tseng 8, Jou-Kou Wang 9
Affiliations expand
PMID: 36602621 PMCID: PMC9813456 DOI: 10.1007/s00431-022-04786-0
Free PMC article
Full text linksCite
Abstract
The purpose of this study is to determine the ECG parameter change and the efficacy of ECG screening for cardiac adverse effect after the second dose of BNT162b2 vaccine in young population. In December 2021, in cooperation with the school vaccination system of Taipei City government, we performed a ECG screening study during the second dose of BNT162b2 vaccines. Serial comparisons of ECGs and questionnaire survey were performed before and after vaccine in four male-predominant senior high schools. Among 7934 eligible students, 4928 (62.1%) were included in the study. The male/female ratio was 4576/352. In total, 763 students (17.1%) had at least one cardiac symptom after the second vaccine dose, mostly chest pain and palpitations. The depolarization and repolarization parameters (QRS duration and QT interval) decreased significantly after the vaccine with increasing heart rate. Abnormal ECGs were obtained in 51 (1.0%) of the students, of which 1 was diagnosed with mild myocarditis and another 4 were judged to have significant arrhythmia. None of the patients needed to be admitted to hospital and all of these symptoms improved spontaneously. Using these five students as a positive outcome, the sensitivity and specificity of this screening method were 100% and 99.1%, respectively.
Conclusion: Cardiac symptoms are common after the second dose of BNT162b2 vaccine, but the incidences of significant arrhythmias and myocarditis are only 0.1%. The serial ECG screening method has high sensitivity and specificity for significant cardiac adverse effect but cost effect needs further discussed. What is Known: • The incidence of cardiac adverse effects was reported to be as high as 1.5 per 10 000 persons after the second dose BNT162b2 COVID-19 vaccine in the young male population based on the reporting system. What is New: • Through this mass ECG screening study after the second dose of BNT162b2 vaccine we found: (1) The depolarization and repolarization parameters (QRS duration and QT interval) decreased significantly after the vaccine with increasing heart rate; (2) the incidence of post-vaccine myocarditis and significant arrhythmia are 0.02% and 0.08%; (3) The serial ECG screening method has high sensitivity and specificity for significant cardiac adverse effect.
Keywords: Arrhythmia; BNT162b2 vaccine; ECG; Myocarditis; Screening.
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Conflict of interest statement
The authors declare no competing interests.
Figures
Fig. 1
Fig. 1 Flow chart of the mass…
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Centers for Disease Control and Prevention (CDC) (2021) Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-v.... Accessed Apr 2022
Frenck RW, Jr, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, Perez JL, et al. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. N Engl J Med. 2021;385:239–250. doi: 10.1056/NEJMoa2107456. - DOI - PMC - PubMed
Centers for Disease Control and Prevention (CDC) (2021) Advisory Committee on Immunization Practices (ACIP). Coronavirus disease 2019 (COVID-19) vaccines. https://www.cdc.gov/vaccines/acip/meetings/slides-2021-2006.html. Accessed Apr 2022
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CCFT 2021-1/Cardiac Children's Foundation Taiwan
CCFT 2021-1/Cardiac Children's Foundation Taiwan
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>>> COVID-19: a potential driver of immune-mediated breast cancer recurrence?
https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-020-01360-0
Published: 30 October 2020
COVID-19: a potential driver of immune-mediated breast cancer recurrence?
Federica Francescangeli, Maria Laura De Angelis & Ann Zeuner
Breast Cancer Research volume 22, Article number: 117 (2020) Cite this article
Abstract
Severe coronavirus disease 2019 (COVID-19) causes a hyperactivation of immune cells, resulting in lung inflammation. Recent studies showed that COVID-19 induces the production of factors previously implicated in the reawakening of dormant breast cancer cells such as neutrophil extracellular traps (NETs). The presence of NETs and of a pro-inflammatory microenvironment may therefore promote breast cancer reactivation, increasing the risk of pulmonary metastasis. Further studies will be required to confirm the link between COVID-19 and cancer recurrence. However, an increased awareness on the potential risks for breast cancer patients with COVID-19 may lead to improved treatment strategies to prevent metastatic relapse.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is spreading in a world where cancer prevalence is rapidly growing, raising concerns about potential interactions between the two diseases. SARS-CoV-2 recruits proteins involved in cellular replication, DNA damage, metabolism, and epigenetic regulation that are also implicated in cancer pathogenesis [1]. At the same time, COVID-19-induced inflammation may affect tumor cells and their microenvironment. The effects of COVID-19 on breast cancer are still unknown. However, emerging evidences suggest that COVID-19 may affect a particular stage in the tumor’s life cycle represented by dormant cancer cells (DCCs). DCCs often survive upon successful treatment of primary tumors and localize in specific microanatomical compartments of metastasis-prone organs, where they can reside in a quiescent state for a clinically asymptomatic period named metastatic dormancy [2]. At some point, DCCs may reactivate in response to microenvironmental cues such as inflammatory or immune-mediated signals, thereby progressing to overt metastasis. Virtually, every patient with a previous history of cancer may harbor DCCs. In breast cancer, understanding the mechanisms underlying cancer cell dormancy and reawakening is of crucial importance due to a particularly broad window of tumor recurrence, encompassing up to two decades after diagnosis.
SARS-CoV-2 infection induces the death of airway epithelial cells with consequent release of damage-associated molecular patterns (DAMPs). DAMPs trigger the production of inflammatory cytokines and chemokines, thus recruiting monocytes, neutrophils and T cells to the lungs (Fig. 1). In the severe phase of COVID-19, lung inflammation leads to diffuse alveolar damage and acute respiratory distress syndrome (ARDS). Moreover, activated immune cells can start a pro-inflammatory loop resulting in systemic inflammation, widespread coagulopathy, and multiorgan dysfunction. Profound immune system alterations also occur upon SARS-CoV-2 infection, including a decrease in natural killer cells and T cells in the peripheral blood, and a dysregulated activation of monocytes, neutrophils, and tissue macrophages [3]. Activated neutrophils release multiple tissue-damaging products including web-like structures of proteins and DNA known as neutrophil extracellular traps (NETs). NETs entrap pathogens and provide for a high local concentration of antimicrobial components, but also create a physical barrier that hinders local access to immune cells.
Modifications in the lung microenvironment occurring during the early and severe phases of SARS-CoV-2 infection and potentially involved in the reawakening of dormant breast cancer cells (DBCCs). During the early phase of COVID-19 (left), SARS-CoV-2 enters pulmonary alveoli and infects airway epithelial cells, which undergo cell death releasing damage-associated molecular patterns (DAMPs). DAMPs activate neighboring cells, starting an inflammatory response that in the severe phase of the disease (right) results in an overproduction of inflammatory cytokines and recruitment of activated monocytes, macrophages, and neutrophils. The latter produces neutrophil extracellular traps (NETs), which contribute to inflammation, immune escape, and thrombosis. NETs, and possibly pro-inflammatory cytokines, can cause DBCC reawakening leading to metastatic outgrowth and tumor relapse
Several factors involved in COVID-19 may play a role in the reawakening of dormant tumor cells. The strongest evidence points to NETs and neutrophils, which are emerging as important players in COVID-19 pathogenesis. NETs involvement in COVID-19 was first proposed upon observation of intense neutrophilic infiltration in the lungs of autopsied COVID-19 patients [4]. The presence of NETs in COVID-19 patients was then confirmed and showed to be responsible for immunothrombosis [5]. Acute lung inflammation and NETs have been respectively shown to trigger the exit from dormancy of breast DCCs, leading to metastasis formation [6, 7]. First, lung inflammation induced by bacterial lipopolysaccharide was shown to induce epithelial-to-mesenchymal transition (EMT) and metastatic reawakening in breast DCCs [7]. Secondly, laminin destruction by NET-associated proteases was reported to activate integrin signaling in lung-resident DCCs, thus inducing proliferation and lung metastasis [6]. Therefore, lung inflammation and NET generation that occur during COVID-19 could trigger DCCs reawakening, possibly acting in concert with other pro-inflammatory factors (Fig. 1). Among these, elevated levels of interleukin-6 and other pro-inflammatory cytokines released during severe COVID-19 result in a widespread activation of NF-?B in both immune and non-immune cells. The induction of NF-?B activation in pre-metastatic niches may contribute to DCCs reawakening both directly by stimulating cancer cell proliferation and indirectly by inducing the formation of a pro-metastatic microenvironment.
Hypoxia, which arises in the blood and tissues of COVID-19 patients upon respiratory distress and thrombosis, is a poor-prognosis microenvironmental hallmark of solid tumors. In breast cancer, hypoxia has been shown to be responsible for DCCs generation by promoting the expression of genes implicated in dormancy, drug resistance, stemness, and EMT [8]. Therefore, hypoxic microenvironments present in COVID-19 patients may play a double role on DCCs, on one side promoting dormancy but on the other side generating an aggressive drug-resistant phenotype that lays the ground for subsequent tumor relapse.
Finally, recent studies on the long-term clinical outcomes of COVID-19 showed a high incidence of persistent symptoms after the acute disease [9]. The possibility that inflammatory and/or autoimmune processes may be a common consequence of SARS-CoV-2 infection raises further concerns about the risks of DCCs reawakening, which may be enhanced in chronically inflamed microenvironments.
Ongoing clinical studies that include an assessment of the long-term effects of COVID-19 on cancer patients [10] will clarify the effects of COVID-19 on the risk of pulmonary metastatic recurrence. If confirmed, the association between COVID-19 and an increased risk of lung metastasis can promote the use of tailored therapies and intensified follow-up schedules in patients with a previous breast cancer. In particular, the use of anti-inflammatory agents able to interfere with immune-mediated inflammatory pathways or NET formation could be helpful in decreasing the risks of subsequent tumor relapse.
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>>> COVID-19 Surges Linked to Spike in Heart Attacks
(note - these articles are always light on the details, and high on the 'obfuscation' scale. A possible role of the Covid vaccines in creating the problem is never even mentioned, much less considered)
Cedars Sinai
Oct 24, 2022
https://www.cedars-sinai.org/newsroom/covid-19-surges-linked-to-spike-in-heart-attacks/#:~:text=By%20the%20second%20year%20of,adults%20age%2065%20and%20older.
The research team members say they have long known that infections such as the flu can increase risk for heart disease and heart attack, but the sharp rise in heart attack deaths is like nothing seen before.
Smidt Heart Institute Study Shows Heart Attack Increase Has Been Most Prominent in Young Adults, Especially Those Ages 25-44
New data analysis from the Smidt Heart Institute at Cedars-Sinai found that deaths from heart attacks rose significantly during pandemic surges, including the COVID-19 Omicron surges, overall reversing a heart-healthier pre-pandemic trend.
Prior to the COVID-19 pandemic, heart attacks were the leading cause of death worldwide but were steadily on the decline. However, the new study—recently published in the peer-reviewed Journal of Medical Virology—shows that heart attack death rates took a sharp turn and increased for all age groups during the pandemic.
The spikes in heart attack deaths have tracked with surges of COVID-19 infection—even during the presumed less-severe Omicron phase of the pandemic. Furthermore, the data showed the increase was most significant among individuals ages 25-44, who are not usually considered at high risk for heart attack.
“The dramatic rise in heart attacks during the pandemic has reversed what was a prior decade long steady improvement in cardiac deaths,” said Yee Hui Yeo, MD, first author of the study and a Cedars-Sinai physician-scientist. “We are still learning the many ways by which COVID-19 affects the body, regardless of age, gender, ethnicity or race.”
Using data from the Centers for Disease Control and Prevention’s National Vital Statistics System, the Cedars-Sinai researchers identified 1,522,699 deaths from heart attacks—medically called acute myocardial infarctions—between April 1, 2012, and March 31, 2022.
Investigators then compared age-related mortality rates between pre-pandemic and pandemic periods, as well as demographic groups and regions.
Key findings from the study include:
In the year before the pandemic, there were 143,787 heart attack deaths; within the first year of the pandemic, this number had increased by 14% to 164,096.
The excess in acute myocardial infarction-associated mortality has persisted throughout the pandemic, even during the most recent period marked by a surge of the presumed less-virulent Omicron variant.
Researchers found that although acute myocardial infarction deaths during the pandemic increased across all age groups, the relative rise was most significant for the youngest group, ages 25 to 44.
By the second year of the pandemic, the “observed” compared to “predicted” rates of heart attack death had increased by 29.9% for adults ages 25-44, by 19.6% for adults ages 45-64, and by 13.7% for adults age 65 and older.
“There are several potential explanations for the rapid rise in cardiac deaths in patients with COVID-19, yet still many unanswered questions,” said Yeo. “Importantly, our results highlight disparities in mortality that have emerged from the COVID-19 pandemic and that are persisting even through the Omicron era.”
The possible explanations, Yeo said, include that COVID-19 may trigger or accelerate the presentation of preexisting coronary artery disease, even in younger adults.
Reasons for the spike in heart-related conditions could also be related to psychological and social challenges associated with the pandemic, including job loss and other financial pressures that can cause acute or chronic stress leading to cardiac disease.
The research team members say they have long known that infections such as the flu can increase risk for heart disease and heart attack, but the sharp rise in heart attack deaths is like nothing seen before.
“There is something very different about how this virus affects the cardiac risks,” said Susan Cheng, MD, MPH, director of the Institute for Research on Healthy Aging in the Department of Cardiology at the Smidt Heart Institute and senior and co-corresponding author of the study. “The difference is likely due to a combination of stress and inflammation, arising from predisposing factors and the way this virus biologically interacts with the cardiovascular system.”
Yeo, Cheng and the broader Smidt Heart Institute team hope that greater awareness and more research will expand the medical community’s ability to manage and mitigate these risks.
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>>> Dramatic rise in cancer in people under 50
(Of course they never mention the 3 DOZEN or so vaccines given between birth and 18 years as a possible source of the problem) - https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html
>>> Dramatic rise in cancer in people under 50
Altered microbiome, sleep deprivation, increase in alcohol consumption among possible culprits in 30-year global trend
The Harvard Gazette
BY Brigham and Women’s Hospital Community
Sept 8, 2022
https://news.harvard.edu/gazette/story/2022/09/researchers-report-dramatic-rise-in-early-onset-cancers/
A study by researchers from Brigham and Women’s Hospital reveals that the incidence of early onset cancers — including breast, colon, esophagus, kidney, liver, and pancreas — has dramatically increased around the world, with the rise beginning around 1990. In an effort to understand why many more people under 50 are being diagnosed with cancer, scientists conducted extensive analyses of available data, including information on early life exposures that might have contributed to the trend. Results are published in Nature Reviews Clinical Oncology.
“From our data, we observed something called the birth cohort effect. This effect shows that each successive group of people born at a later time — e.g., a decade later — have a higher risk of developing cancer later in life, likely due to risk factors they were exposed to at a young age,” said Shuji Ogino, a professor at Harvard Chan School and Harvard Medical School and a physician-scientist in the Department of Pathology at the Brigham. “We found that this risk is increasing with each generation. For instance, people born in 1960 experienced higher cancer risk before they turn 50 than people born in 1950, and we predict that this risk level will continue to climb in successive generations.”
Ogino worked with lead author Tomotaka Ugai and colleagues from 2000 to 2012 to analyze global data on 14 cancer types that showed increased incidence in adults before age 50. Then the team searched for available studies that examined trends of possible risk factors, including early life exposures in the general populations. Finally, the researchers examined the literature describing clinical and biological tumor characteristics of early onset cancers compared with cancers diagnosed after age 50.
“We found that this risk is increasing with each generation.”
— Shuji Ogino, professor, physician-scientist
In an extensive review, the team found that the early life “exposome,” which encompasses an individual’s diet, lifestyle, weight, environmental exposures, and microbiome, has changed substantially in the last several decades. They hypothesize that factors like the Western diet and lifestyle may be contributing to the rise in early onset cancer. The team acknowledged that this increased incidence of certain cancer types is, in part, due to early detection through cancer screening programs. They couldn’t precisely measure what proportion of this growing prevalence could solely be attributed to screening and early detection. However, they noted that increased incidence of many of the 14 cancer types is unlikely due to enhanced screening alone.
Possible risk factors for early onset cancer included alcohol consumption, sleep deprivation, smoking, obesity, and eating highly processed foods. Surprisingly, researchers found that while adult sleep duration hasn’t drastically changed over the several decades, children are getting far less sleep today than they were decades ago. Risk factors such as highly processed foods, sugary beverages, obesity, Type 2 diabetes, sedentary lifestyle, and alcohol consumption have all significantly increased since the 1950s.
“Among the 14 cancer types on the rise that we studied, eight were related to the digestive system. The food we eat feeds the microorganisms in our gut,” said Ugai. “Diet directly affects microbiome composition and eventually these changes can influence disease risk and outcomes.”
One limitation of this study is that researchers did not have an adequate amount of data from low- and middle-income countries to identify trends in cancer incidence over the decades. Going forward, Ogino and Ugai hope to continue this research by collecting more data and collaborating with international research institutes to better monitor global trends. They also explained the importance of conducting longitudinal cohort studies with parental consent to include young children who may be followed up for several decades.
“Without such studies, it’s difficult to identify what someone having cancer now did decades ago or when one was a child,” said Ugai. “Because of this challenge, we aim to run more longitudinal cohort studies in the future where we follow the same cohort of participants over the course of their lives, collecting health data, potentially from electronic health records, and biospecimens at set time points. This is not only more cost effective considering the many cancer types needed to be studied, but I believe it will yield us more accurate insights into cancer risk for generations to come.”
Ogino’s work is supported in part by the U.S. National Institutes of Health grants and the Cancer Research UK’s Cancer Grand Challenge Award. Ugai’s work is supported by grants from the Prevent Cancer Foundation, Japan Society for the Promotion of Science, and Mishima Kaiun Memorial Foundation.
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Another young athlete drops from a heart attack, this time on Monday Night Football. With 15-20 million Americans watching tonight's game, it will be hard for the controlled media to make this event disappear 'down the memory hole', though they'll undoubtedly try.
The Covid vaccines have known cardiovascular effects like pericarditis, myocarditis, and
arrhythmias, particularly in young males. Covid itself likewise has cardio effects, blood clots, etc. A 37 year old ABC executive producer recently died of a heart attack, but nothing to see here folks, go back to sleep -
>>> At least 69 athletes collapse in one month, many dead
The reports of athletes who suddenly collapse have been increasing noticeably lately. Heart problems such as heart inflammation are often the cause – one of the known life-threatening side effects of Covid vaccines, which even the manufacturers themselves warn against.
November 26, 2021
https://dpbh.nv.gov/uploadedFiles/dpbhnvgov/content/Boards/BOH/Meetings/2021/Public%20Comments%20324%20to%20328.pdf
The current phenomenon is also evident if you simply look on Wikipedia at the list of footballers who have collapsed and died. The year 2021 stands out with 13 entries so far. In no other year mentioned have more footballers died during a game. And this list goes back to the year 1889. So it really is a historical event.
The mainstream media is curiously uninterested in this major global story. The German online outlet Wochenblick compiled a referenced list of the cardiac incidents in October while another online outlet Granite Grok published a new list of sportsmen collapsing on the field. Other outlets also listed these incidents, with some cases overlapping.
But these do not include Filipino professional basketball star Roider Cabrera who on Wednesday collapsed
during tournament play in Pasig City. The Tribune from the Philippines reported he had a cardiac arrest. Roider Cabrera later lost consciousness inside the locker room before he was immediately rushed to hospital where he was diagnosed with fatal arrhythmia according to a local news.
Many top athletes from both Europe and the US have reported serious side effects after a Covid jab. For
French professional tennis player Jérémy Chardy, it has meant the end of his career. Chardy, formerly ranked
73 in the world, said he has been unable to train and play. “Since I got my vaccine [between the Olympics and
the US Open], I have a problem, I have a series of problems. As a result, I can’t train, I can’t play.”
Icelandic professional footballer Emil Pálsson (28) collapsed in the game between his club Sogndal IL and
Stjørdals/Blink. As reported by German daily Bild, Pálsson collapsed during the game, according to the Norwegian broadcaster NRK and the newspaper Verdens Gang. According to his club, he suffered cardiac arrest and had to be resuscitated.
This week, on November 24, in the middle of the second half of the game between Reading FC and Sheffield
United, Sheffield player John Fleck (30) suddenly collapsed on the field due to a cardiac incident and had to
be rushed to hospital.
Soccer star from Sheriff Tiraspol Adama Traore went down while holding his chest during the Champions
League game against Real Madrid on Wednesday night.
In Montana, a Park City High School football player Jedd Hoffman, passed away this month, almost one week after collapsing on the field during practice. These are cases not yet listed in the ongoing carnage that the jabs
have unleashed.
In October cardiac and circulatory events on the sportsfield went through the roof
Below is a shockingly long list of athletes who collapsed last month from heart problems or circulatory disorders such as strokes. Unfortunately, some of these incidents were fatal for the often very young athletes. The numbers are alarming, especially in view of mandatory Covid shots.
(1) At the encounter between PGS E Bosico and Romeo Menti (Allerona Scalo) in Umbria/Italy on October 2,
2021 , a “young player” from the visiting team collapses without any external influence and is transported to the
hospital.
(2) Martin Lefèvre (16) from FC Agneaux collapses without any previous illnesses with a stroke during the game
against FC Saint-Lô Manche on October 2, 2021. He is paralyzed on one side and has no ability to speak.
(3) Niels de Wolf, 27, from the Belgian football club White Star Sombeke, suffered a cardiac arrest immediately
after the game against Verrebroek on October 3, 2021, was resuscitated with a defibrillator, but died in hospital
on October 6, 2021.
(4) Arcisate, Province of Varese, Italy: The amateur match between Valceresio and Tradate (Prima Categoria,
Girone A) is canceled after 20 minutes after the referee suffers a medical emergency . Message from October 3,
2021.
(5) Timucin Sen from Germania Großkrotzenburg will be substituted on October 3, 2021 in the game against
Spvgg. Oberrad. He collapsed after ten minutes into the game and was taken to a clinic in Gelnhausen.
(6) On October 3, 2021, referee Öner Calik, in his mid-30s, canceled the game between VfB Waltrop II and
Vinnum II due to his own health problems and was taken to the hospital by the emergency doctor.
(7) On October 4 , 2021, a person in charge of SV SW Frömern collapsed on the field before the game against
Kamener SC.
(8) Cleveland, Ohio, USA: Elias Abou Nassif (44) suffers cardiac arrest in the gym and can be saved by using a
defibrillator. Message from October 5, 2021
(9) Lecco (Italy), October 7, 2021: 17-year-old athlete from Colverde collapses during training with cardiac
arrest. Defibrillator insert. He is now fighting for his life in the intensive care unit at Lecco Hospital.
(10) AH player (49) from SC Massay in France suffers a fatal heart attack during a game on October 8, 2021.
(11) The golf caddy Alberto Olguín from Mexico collapses dead on the ninth hole of the tournament in Nuevo
Vallarta (Mexico). Message from October 9, 2021.
(12) England: In the League One game between Ipswich Town and Shrewsbury on October 9, 2021, Shrewsbury
professional striker Ryan Bowman (29) has to be taken off the field after a good half hour of play with extreme
cardiac arrhythmias and a pulse of 250 and treated with a defibrillator.
(13) Pompeo Tretola, an 18-year-old soccer player from FC Matese, collapses during the game against Vastese
Calcio on 10.10.2021 without any warning signs. He is later transported to the hospital.
(14) Normandy, France: After warming up before the match between Saint-James and Avranches on 10 October
2021, 40-year-old player from Saint-James suffers a heart attack and is saved by a fire-medic on the team of
Avranches.
(15) 59-year-old long-distance runner from Biella dies of heart failure in a race in northern Italy. Message from
10/10/2021.
(16) In the match between Wacker Mecklenbeck and Fortuna Freudenberg in the Women’s Westphalia League
on October 10, 2021, a player collapsed without any opposing influence and was transported to the Münster
University Hospital.
(17) Argentina: Mayor Guillermo Mercado (50) died of cardiac arrest after participating in the long-distance run
“Aventura de Cerezal” . Message from 10/11/2021.
(18) At the Boston Marathon on October 11, 2021, marathon star Megan Roth collapsed after eight miles of
racing with cardiac arrest. She can be saved and is waiting for a defibrillator to be implanted.
(19) NBA player Brandon Godwin of the Atlanta Hawks explains that the Covid vaccination had caused severe
side effects for him, which would mean that he not only had to end the season, but possibly his entire career.
Message from October 12, 2021.
(20) Le Havre, France: A 27-year-old policeman suffers a fatal heart attack while jogging. News from October
12, 2021.
(21) Ferran Duran, player from the 4 Catalan League (27), suffered cardiac arrest five times during a game on
October 12, 2021 and miraculously survived.
(22) France: The player Christophe Da Silva of Saint Avé collapses with cardiac arrest in the AH Cup match
between the Locqueltas footballers and Saint Avé . Message from 10/13/2021
(23) Ensenada, Mexico: The 16-year-old student Héctor Manuel Mendoza dies of a “fulminant heart attack” while training in a sports club . Message from 10/13/2021.
(24) Brazil: Atletico Goianiense ‘s youth footballer Fellipe de Jesus Moreira suffers a heart attack in the training
center and later another heart attack in the emergency room. Now he is fighting for his life in the intensive care
unit. News from October 14, 2021.
(25) The next referee who breaks down and dies during a game : happened at the Kreisliga B game between SC
Daisbach and FSV Taunusstein in Aarbergen on the evening of October 14, 2021.
(26) The professional cyclist and multiple Italian time trial champion Gianni Moscon (27) is about to have a
catheter ablation due to cardiac arrhythmia. News from October 14, 2021.
(27) Joe Plant from Whitby (Yorkshire, England) suffers in 2021 at a race walking competition of all the British
Heart Foundation a cardiac arrest, at 14:10, he himself reported.
(28) Lars Schneider, trainer of TV Braach, retires due to lack of strength after he collapsed with cardiac
arrhythmias during the game of the district league A Hersfeld / Rotenburg against SG
NentershausenWeißenhasel-Solz in Solz and had to be transported to the clinic. Message from 10/14/2021.
(29) Treviso, Italy: 53-year-old AH player suffers a heart attack while training on October 14, 2021 . He could be
kept alive by fellow players.
(30) Australia: 14-year-old student Ava Azzopardi suffers cardiac arrest during the game between Runaway Bay
and Magic United at Surfers Paradise Apollo Soccer Club. She is resuscitated by nine rescue workers, put into an
artificial coma and is now fighting for her life in the hospital. News from October 15, 2021.
(31) At the handball 3G Bundesliga game in Wuppertal between Bergisches HC and HSG Wetzlar on October 16
, 2021 , a spectator with cardiac arrest collapsed not only during the game (this led to the game being
abandoned); after the game, a second spectator also suffered a cardiac arrest .
(32) A 16-year-old boy from Idaho collapses when lifting weights with cardiac arrest. He wakes up after two days
in a coma, but is “extremely confused” and has no short-term memory. News from October 16, 2021.
(33) Camposampiero, Province of Padua, Italy: The 37-year-old doctor Filippo Morando dies while jogging. The
ambulance flown in by helicopter can no longer do anything as it is too late. Message from 10/17/2021.
(34) The Premier League game between Newcastle United and Tottenham FC on October 17, 2021 was
suspended due to a medical emergency in the stands.
(35) Haitem Jabeur Fathallah, 32, a Fortitudo Messina basketball player, suffers cardiac arrest during the game
and dies in hospital. Message from 10/17/2021.
(36) Blumenau, Brazil: Former FC Brusque soccer player from the Brazilian second division, Adans Joao Santos
Alencar (38) , suffers a fatal cardiac arrest in a footvolley tournament. Message from 10/17/2021.
(37) Lombardy, Italy: A 40-year-old cyclist stops because of “medical emergency” on , falls to the ground, is
transported to the hospital by rescue helicopter Rho. Message from 10/17/2021.
(38) Waseem Aslam of Bradford (England) interrupts a game of football suffering from a cardiac arrest. He
could be saved by friends. Message from October 18, 2021.
(39 ) A 26-year-old runner collapses from cardiac arrest in the Detroit Free Press Marathon . Two police officers
rescue him with chest compressions. After that he was treated in the hospital. Message from October 19, 2021.
(40) Cardiac arrhythmias force soccer star Sabrina Soravilla to end her career on October 19 , 2021 after 68
international matches for Uruguay.
(41) Real Murcia’s Antonio López had to retire at the age of 32 due to a heart disease . Message from October 19,
2021.
(42) A 41-year-old amateur soccer player in Brazil dies of cardiac arrest in a game. It happened on October 19,
2021 in Nao-me-toque (Rio Grande do Sul).
(43) Henry, a teenager from Halifax, England, is recognized for saving the life of his 56-year-old father after a
cardiac arrest while jogging in March. Message from October 20, 2021.
(44) At the first division match between Osasuna and Granada in Pamplona on October 22, 2021, a home team
fan suffers cardiac arrest and dies in hospital.
(45) Dieppe, France: A jogger collapses while running with cardiac arrest. He is rescued by two police officers on
the patrol. Message from 10/22/2021.
(46) Acerra (Italy): Remigio Gova. A basketball referee and nurse, in Italy inevitably “vaccinated” against Covid,
at only 30 years of age “died in his sleep”. Message from October 23, 2021.
(47) A double medical emergency at an English stadium on 10/23/2021 during the Championship League game
between West Brom and Bristol City. Defibrillator used, the game had to be postponed twice.
(48) Belgian soccer player (37) suffered cardiac arrest in the locker room after his club’s match on October 24th,
2021, was reanimated but died in hospital.
(49) France: 43-year-old US Montgascon goalkeeper dies of cardiac arrest at half-time. Happened on October
24, 2021 at the La Bâtie-Montgascon stadium.
(50) A 53-year-old suffers a triple cardiac arrest in Bilbao half-marathon and passes away as a result. Message
from October 24, 2021.
(51) Tevita Brice, 28, of Montclair Rugby Football Club, US, collapsed on the pitch with a heart attack. In critical
condition. Message from 10/25/2021.
(52) Fatal cardiac arrest at a mountain running event in the Italian Alps on October 24, 2021. The victim is
Bruno Taffarel (56) from Cordenons.
(53) A cardiac arrest of a player overshadowed the top game of the A2 Dortmund regional soccer league. The
player from SG Gahmen was hospitalized on 10/24/2021. The affected team had played against Eving Selimiye
Spor.
(54) Nocera Umbra, Italy: Sports teacher and soccer coach Mario Mingarelli suffered fatal cardiac arrest during
his team’s game on October 24, 2021 at the age of 69 .
(55) The amateur match between Frugesport (Ravenna) and Vaccolino (Prima Categoria, Girone F) is canceled
after 32 minutes because the “young” referee suffers a medical emergency . Message from 10/26/2021.
(56) 17-year-old Elly Böttcher from Rostocker FC collapsed unconscious during the away game in Hohen
Neuendorf of the Frauen Regionalliga Nordost on October 24, 2021 without any interference and was
transported to the hospital. The game was stopped after the incident.
(57) A 20-year-old Italian collapses when skateboarding with a cardiac arrest and is now fighting for his life in
the hospital in Verona, where he was transported by helicopter. News from October 25, 2021.
(58) A fan of the Belgian second division team from Lier collapsed on October 27, 2021 in the stadium with
heart problems and died in hospital.
(59) On the same day (27.10.2021) also in Belgium, the cup match against Dender of Eupen: A fan collapses
with cardiac arrest and must be revived.
(60) Sassuolo, Italy: A 53-year-old mountain biker suffers fatal cardiac arrest on an off-road tour. Message from
10/27/2021.
(61) England: A fan collapses after the Cup game Stoke City against Brentford on October 27, 2021 in front of
the stadium with cardiac arrest and dies.
(62) A player from Blau-Weiß Linz from Ghana (26) collapses during his club’s home game against Hartberg
and is transported to the hospital. Happened on October 27, 2021 at the round of 16 for the ÖFB-Pokal. He is
diagnosed with a congenital heart rhythm disorder and was helped with a defibrillator.
(63) Pakistan: The 30-year-old player Muhammad Islam from FC Raziq Chaman suffers a heart attack in the
middle of the game against Millat Club and dies. Message from 10/28/2021.
(64) The Swedish-Iraqi player Aimar Sher from the Italian first division club Spezia Calcio collapses during
training and is transported to the hospital. Message from 10/28/2021.
(65) Pennsylvania, USA: A 12-year-old student at Chartiers Valley Middle School collapses while playing
basketball in physical education class without help and dies. Message from 10/28/2021.
(66) Barcelona star Sergio Aguero (33) suddenly gets breathless during the league game against Deportivo
Alaves, grabs his chest and collapses. The Argentine national team player must now take a break of at least three
months. A few months ago he was suffering from a severe Corona infection. Notification from 10/30/2021
(67) During the ICE ice hockey league game, Boris Sadecky (24) from the Bratislava Capitals collapses on the ice without any outside interference. He dies five days later. It later emerges that he suffered from “mild
myocarditis” on match day. Message from 10/30/2021
(68) The student and soccer coach for the La Salle High School team in Pennsylvania, USA Blake Barklage died
after a heart attack over the weekend. Message from 11/1/2021.
(69) Argentina: The soccer player Ronald Biglione dies after the 2nd vaccination due to thrombosis – a wellknown side effect of the vaccinations against which the manufacturers themselves warned about. He was treated in Cordoba hospital for two weeks. Message from November 5, 2021.
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>>> Nearly half of passengers from China to Milan have COVID: Italian officials
The Hill
BY JULIA SHAPERO
2/28/22
https://thehill.com/policy/healthcare/3790837-nearly-half-of-passengers-from-china-to-milan-have-covid-italian-officials/
Nearly half of the passengers on two recent flights from China to Milan tested positive for COVID-19, Italian health officials said on Wednesday.
About 38 percent of passengers on one flight into Milan’s Malpensa Airport tested positive for COVID, as did about 52 percent of those on a second flight, according to local officials in Italy’s Lombardy region.
Italy will begin testing all new arrivals from China and sequencing the tests for new variants, amid China’s surge in COVID cases, Italy’s health minister said on Wednesday.
“The measure is essential to ensure surveillance and detection of possible variants of the virus in order to protect the Italian population,” Italian Health Minister Orazio Schillaci said.
Several other countries, including Japan, India, South Korea, Taiwan and Malaysia, have already instituted similar requirements, with U.S. officials considering following suit, according to CBS News.
After walking back its strict “zero-COVID” policies this month following a series of mass protests, China has faced a surge in cases that has reportedly overwhelmed hospitals.
While official numbers remain low, an internal estimate suggested that nearly 250 million people may have caught COVID in the first 20 days of the month, the Financial Times reported last week.
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>>> U.S. FDA gives first-ever approval to fecal transplant therapy
Reuters
November 30, 2022
https://www.yahoo.com/news/u-fda-approves-ferring-pharmas-215405412.html
(Reuters) -The U.S. health regulator on Wednesday approved Switzerland-based Ferring Pharmaceuticals' fecal transplant-based therapy to reduce the recurrence of a bacterial infection, making it the first therapy of its kind to be cleared in the United States.
The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. In the United States, the infection is associated with 15,000-30,000 deaths annually.
While this is the first such therapy approved by the Food and Drug Administration (FDA) for recurrent C. difficile infections, fecal microbiota transplants – classified by the regulator as investigational – have long been the standard of care in the U.S. for this condition.
"As the first FDA-approved fecal microbiota product, (the) action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI," said Peter Marks, director of the agency's Center for Biologics Evaluation and Research.
Rebyota is delivered through an enema and works by replenishing good gut bacteria through samples of microbes distilled from faeces of healthy donors.
Approval for the therapy comes on the back of a positive vote from the regulator's advisers in September, as most on the panel sought standardization of the therapy.
Ferring, which gained the therapy through its 2018 purchase of U.S.-based Rebiotix Inc, was not immediately available for a comment on pricing and availability of the therapy.
Besides Ferring, other companies including Seres Therapeutics, which is developing an oral treatment, are working on similar therapies based on fecal microbiota transplantation.
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>>> Vaccinated Americans a majority of COVID deaths for first time in August
Fox News
by Chris Pandolfo
November 23, 2022
https://www.yahoo.com/news/vaccinated-americans-majority-covid-deaths-191724608.html
For the first time since the beginning of the pandemic, a majority of Americans dying from the coronavirus were at least partially vaccinated, according to a new analysis of federal and state data.
The waning efficacy of COVID-19 vaccines and increasingly contagious strains of the virus being spread to elderly and immunocompromised people have resulted in more deaths among those who have taken at least one vaccine dose, a Washington Post analysis published Wednesday finds.
"Fifty-eight percent of coronavirus deaths in August were people who were vaccinated or boosted," the Post reported.
The paper described a "troubling trend" as the share of deaths of people who were vaccinated has been "steadily rising" over the past year.
"In September 2021, vaccinated people made up just 23 percent of coronavirus fatalities. In January and February this year, it was up to 42 percent," the Washington Post's Fenit Nirappil and Dan Keating wrote.
"We can no longer say this is a pandemic of the unvaccinated," said Kaiser Family Foundation vice president Cynthia Cox, who conducted the analysis on behalf of the Post.
Top health officials have repeatedly urged Americans to complete their primary vaccine series and get boosted to maximize vaccine protection against COVID-19.
"Bottom line is that we're doing everything we can in the next six weeks to help families get their updated COVID shots by the end of the year (even though they don't work), because it's the best protection for this winter," Jha said, adding that the latest iteration of the COVID-19 vaccine is a "once a year shot," similar to the flu shot.
Outgoing White House Chief Medical Adviser Dr. Anthony Fauci also spoke at Tuesday's press briefing, where he delivered his "final message" before stepping down at the end of the year.
Fauci emphasized the safety and efficacy of the approved COVID-19 vaccines in preventing severe illness and deaths and encouraged Americans to get vaccinated and boosted as soon as possible. He noted that coronavirus vaccine effectiveness wanes over time and said the disease shouldn't be compared to other vaccine-treatable illnesses like measles because of new emerging variants every few months.
"My message, and my final message, maybe the final message I give you from this podium, is that please, for your own safety, for that of your family, get your updated COVID 19 shot as soon as you're eligible to protect yourself, your family and your community," Fauci said. "I urge you to visit vaccine.gov to find a location where you can easily get an updated vaccine, and please do it as soon as possible."
Multiple medical experts, including Fauci and Dr. Deborah Birx, have acknowledged that the coronavirus vaccines do not necessarily protect people against infection and transmission.
Despite this, several people, including Florida Surgeon General Dr. Joseph Lapado, were criticized for suggesting that COVID vaccines were not as effective as originally claimed.
In October, a New York state Supreme Court ordered all employees who were fired because of New York City's vaccine mandate be reinstated with back pay, finding that "being vaccinated does not prevent an individual from contracting or transmitting COVID-19."
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>>> A horrifying amount of microplastic discharges from nonstick pans and goes into our food, study says
MSN
by Matthew Rozsa
Nov 4, 2022
https://www.msn.com/en-us/health/medical/a-horrifying-amount-of-microplastic-discharges-from-nonstick-pans-and-goes-into-our-food-study-says/ar-AA13JOy6?cvid=e9318b743e4e4e11859485b893a37f03
Everyone knows the name Teflon, the patented nonstick coating chemical discovered by DuPont in 1938 — which is convenient because the full name for the type of synthetic polymer that includes Teflon, "per- and polyfluoroalkyl substances" (PFAS), is quite the tongue-twister. Although such cookware is beloved by cooks for making cleaning easier, Teflon and other so-called "forever chemicals" in non-stick pans have been turning up in human bodies, and are linked to ailments ranging from high blood pressure and low sperm count to liver disease. It stands to reason that consumers would like PFAS such as Teflon to stay on their cookware and off their food, even though anyone who has prepared a meal knows that does not always happen.
"We must be careful about selecting and using cooking utensils to avoid food contamination."
Now, a new study in the journal Science of the Total Environment reveals that a single surface crack in the teflon coating of a frying pan can eject as many as 9,100 plastic particles, more than enough to enter the human body.
Like the chemicals they studied, the scientists behind this breakthrough hail from an organization whose name is a mouthful. Researchers from the Global Centre for Environmental Remediation and Flinders Institute of NanoScale Science and Engineering used Raman imaging and an algorithm model to visualize microplastics and nanoplastics alike on a microscopic scale. Using this data, they identified that 2.3 million microplastics and nanoplastics were released when a frying pan's teflon coating is broken.
What is microplastic anyway? Inside the insidious pollution that is absolutely everywhere
"The non-stick coating material Teflon is generally a family member of PFAS," University of Newcastle researcher Dr Cheng Fang, who was involved in the study, said in a press statement. "Given the fact PFAS is a big concern, these Teflon microparticles in our food might be a health concern [and] needs investigating, because we don't know much about these emerging contaminants."
Flinders University researcher Professor Youhong Tang added in the statement that the study is a warning about the danger of not cooking in a safe way. Notably, most nonstick pans have instructions that say not to heat them above medium, though the great variation in home stoves means that even rule-following home cooks might not always succeed at keeping such pans from emitting odorless fumes that have been known to kill birds in poorly ventilated rooms.
"It gives us a strong warning that we must be careful about selecting and using cooking utensils to avoid food contamination," Tang said in the statement. "More research is recommended to address the risk assessment of the Teflon microplastics and nanoplastics, given that Teflon is a family member of PFAS."
"It's very difficult for individuals to control their PFAS exposure – PFAS are in so many products (and water, or food) and often we don't even know we are exposed."
In addition to appearing on cooking pans, PFAS can be found in fast food wrappers, popcorn bags and countless other types of commonly-used kitchenware. They are literally inescapable, and that is why the American Heart Association journal Hypertension was so alarmed in June when it studied 1,000 middle-aged women and discovered that "women with higher concentrations of specific PFAS were more likely to develop high blood pressure." More specifically, "women in the highest one-third concentrations of all seven PFAS examined had a 71% increased risk of developing high blood pressure," the study found. High blood pressure can lead to heart attacks and strokes if left untreated.
In another study that isolated seven common PFAS, a report last month in the journal Environmental Health Perspectives found that when pregnant mothers in their first trimester were exposed to a mixture of those PFAS, their biologically male children wound up having "lower sperm concentration, lower total sperm count, and higher proportions of nonprogressive and immotile sperm in young adulthood." Meanwhile a systematic review of scientific literature published in May by the journal Environmental Health Perspectives revealed that there is "a relationship between higher exposure to certain PFAS chemicals and higher blood levels of ALT," or the liver enzyme Alanine Aminotransferease. Study author Liz Costello told Salon at the time that the enzyme is "a good indicator of liver injury." Costello also commented on the ubiquity of PFAS.
"It's very difficult for individuals to control their PFAS exposure – PFAS are in so many products (and water, or food) and often we don't even know we are exposed," Costello explained. "Even when older PFAS are phased out and no longer used, newer PFAS chemicals replace them. You won't usually see these listed on a product label."
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>>> ResMed Inc. (RMD) develops, manufactures, distributes, and markets medical devices and cloud-based software applications for the healthcare markets. The company operates in two segments, Sleep and Respiratory Care, and Software as a Service. It offers various products and solutions for a range of respiratory disorders, including technologies to be applied in medical and consumer products, ventilation devices, diagnostic products, mask systems for use in the hospital and home, headgear and other accessories, dental devices, and cloud-based software informatics solutions to manage patient outcomes, as well as provides customer and business processes. The company also provides AirView, a cloud-based system that enables remote monitoring and changing of patients' device settings; myAir, a personalized therapy management application for patients with sleep apnea that provides support, education, and troubleshooting tools for increased patient engagement and improved compliance; U-Sleep, a compliance monitoring solution that enables home medical equipment (HME)to streamline their sleep programs; connectivity module and propeller solutions; and Propeller portal. It offers out-of-hospital software solution, such as Brightree business management software and service solutions to providers of HME, pharmacy, home infusion, orthotics, and prosthetics services; MatrixCare care management and related ancillary solutions to senior living, skilled nursing, life plan communities, home health, home care, and hospice organizations, as well as related accountable care organizations; and HEALTHCAREfirst that offers electronic health record, software, billing and coding services, and analytics for home health and hospice agencies. The company markets its products primarily to sleep clinics, home healthcare dealers, and hospitals through a network of distributors and direct sales force in approximately 140 countries. ResMed Inc. was founded in 1989 and is headquartered in San Diego, California.
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>>> At least 69 athletes collapse in one month, many dead
The reports of athletes who suddenly collapse have been increasing noticeably lately. Heart problems such as heart inflammation are often the cause – one of the known life-threatening side effects of Covid vaccines, which even the manufacturers themselves warn against.
November 26, 2021
https://dpbh.nv.gov/uploadedFiles/dpbhnvgov/content/Boards/BOH/Meetings/2021/Public%20Comments%20324%20to%20328.pdf
The current phenomenon is also evident if you simply look on Wikipedia at the list of footballers who have collapsed and died. The year 2021 stands out with 13 entries so far. In no other year mentioned have more footballers died during a game. And this list goes back to the year 1889. So it really is a historical event.
The mainstream media is curiously uninterested in this major global story. The German online outlet Wochenblick compiled a referenced list of the cardiac incidents in October while another online outlet Granite Grok published a new list of sportsmen collapsing on the field. Other outlets also listed these incidents, with some cases overlapping.
But these do not include Filipino professional basketball star Roider Cabrera who on Wednesday collapsed
during tournament play in Pasig City. The Tribune from the Philippines reported he had a cardiac arrest. Roider Cabrera later lost consciousness inside the locker room before he was immediately rushed to hospital where he was diagnosed with fatal arrhythmia according to a local news.
Many top athletes from both Europe and the US have reported serious side effects after a Covid jab. For
French professional tennis player Jérémy Chardy, it has meant the end of his career. Chardy, formerly ranked
73 in the world, said he has been unable to train and play. “Since I got my vaccine [between the Olympics and
the US Open], I have a problem, I have a series of problems. As a result, I can’t train, I can’t play.”
Icelandic professional footballer Emil Pálsson (28) collapsed in the game between his club Sogndal IL and
Stjørdals/Blink. As reported by German daily Bild, Pálsson collapsed during the game, according to the Norwegian broadcaster NRK and the newspaper Verdens Gang. According to his club, he suffered cardiac arrest and had to be resuscitated.
This week, on November 24, in the middle of the second half of the game between Reading FC and Sheffield
United, Sheffield player John Fleck (30) suddenly collapsed on the field due to a cardiac incident and had to
be rushed to hospital.
Soccer star from Sheriff Tiraspol Adama Traore went down while holding his chest during the Champions
League game against Real Madrid on Wednesday night.
In Montana, a Park City High School football player Jedd Hoffman, passed away this month, almost one week after collapsing on the field during practice. These are cases not yet listed in the ongoing carnage that the jabs
have unleashed.
In October cardiac and circulatory events on the sportsfield went through the roof
Below is a shockingly long list of athletes who collapsed last month from heart problems or circulatory disorders such as strokes. Unfortunately, some of these incidents were fatal for the often very young athletes. The numbers are alarming, especially in view of mandatory Covid shots.
(1) At the encounter between PGS E Bosico and Romeo Menti (Allerona Scalo) in Umbria/Italy on October 2,
2021 , a “young player” from the visiting team collapses without any external influence and is transported to the
hospital.
(2) Martin Lefèvre (16) from FC Agneaux collapses without any previous illnesses with a stroke during the game
against FC Saint-Lô Manche on October 2, 2021. He is paralyzed on one side and has no ability to speak.
(3) Niels de Wolf, 27, from the Belgian football club White Star Sombeke, suffered a cardiac arrest immediately
after the game against Verrebroek on October 3, 2021, was resuscitated with a defibrillator, but died in hospital
on October 6, 2021.
(4) Arcisate, Province of Varese, Italy: The amateur match between Valceresio and Tradate (Prima Categoria,
Girone A) is canceled after 20 minutes after the referee suffers a medical emergency . Message from October 3,
2021.
(5) Timucin Sen from Germania Großkrotzenburg will be substituted on October 3, 2021 in the game against
Spvgg. Oberrad. He collapsed after ten minutes into the game and was taken to a clinic in Gelnhausen.
(6) On October 3, 2021, referee Öner Calik, in his mid-30s, canceled the game between VfB Waltrop II and
Vinnum II due to his own health problems and was taken to the hospital by the emergency doctor.
(7) On October 4 , 2021, a person in charge of SV SW Frömern collapsed on the field before the game against
Kamener SC.
(8) Cleveland, Ohio, USA: Elias Abou Nassif (44) suffers cardiac arrest in the gym and can be saved by using a
defibrillator. Message from October 5, 2021
(9) Lecco (Italy), October 7, 2021: 17-year-old athlete from Colverde collapses during training with cardiac
arrest. Defibrillator insert. He is now fighting for his life in the intensive care unit at Lecco Hospital.
(10) AH player (49) from SC Massay in France suffers a fatal heart attack during a game on October 8, 2021.
(11) The golf caddy Alberto Olguín from Mexico collapses dead on the ninth hole of the tournament in Nuevo
Vallarta (Mexico). Message from October 9, 2021.
(12) England: In the League One game between Ipswich Town and Shrewsbury on October 9, 2021, Shrewsbury
professional striker Ryan Bowman (29) has to be taken off the field after a good half hour of play with extreme
cardiac arrhythmias and a pulse of 250 and treated with a defibrillator.
(13) Pompeo Tretola, an 18-year-old soccer player from FC Matese, collapses during the game against Vastese
Calcio on 10.10.2021 without any warning signs. He is later transported to the hospital.
(14) Normandy, France: After warming up before the match between Saint-James and Avranches on 10 October
2021, 40-year-old player from Saint-James suffers a heart attack and is saved by a fire-medic on the team of
Avranches.
(15) 59-year-old long-distance runner from Biella dies of heart failure in a race in northern Italy. Message from
10/10/2021.
(16) In the match between Wacker Mecklenbeck and Fortuna Freudenberg in the Women’s Westphalia League
on October 10, 2021, a player collapsed without any opposing influence and was transported to the Münster
University Hospital.
(17) Argentina: Mayor Guillermo Mercado (50) died of cardiac arrest after participating in the long-distance run
“Aventura de Cerezal” . Message from 10/11/2021.
(18) At the Boston Marathon on October 11, 2021, marathon star Megan Roth collapsed after eight miles of
racing with cardiac arrest. She can be saved and is waiting for a defibrillator to be implanted.
(19) NBA player Brandon Godwin of the Atlanta Hawks explains that the Covid vaccination had caused severe
side effects for him, which would mean that he not only had to end the season, but possibly his entire career.
Message from October 12, 2021.
(20) Le Havre, France: A 27-year-old policeman suffers a fatal heart attack while jogging. News from October
12, 2021.
(21) Ferran Duran, player from the 4 Catalan League (27), suffered cardiac arrest five times during a game on
October 12, 2021 and miraculously survived.
(22) France: The player Christophe Da Silva of Saint Avé collapses with cardiac arrest in the AH Cup match
between the Locqueltas footballers and Saint Avé . Message from 10/13/2021
(23) Ensenada, Mexico: The 16-year-old student Héctor Manuel Mendoza dies of a “fulminant heart attack” while training in a sports club . Message from 10/13/2021.
(24) Brazil: Atletico Goianiense ‘s youth footballer Fellipe de Jesus Moreira suffers a heart attack in the training
center and later another heart attack in the emergency room. Now he is fighting for his life in the intensive care
unit. News from October 14, 2021.
(25) The next referee who breaks down and dies during a game : happened at the Kreisliga B game between SC
Daisbach and FSV Taunusstein in Aarbergen on the evening of October 14, 2021.
(26) The professional cyclist and multiple Italian time trial champion Gianni Moscon (27) is about to have a
catheter ablation due to cardiac arrhythmia. News from October 14, 2021.
(27) Joe Plant from Whitby (Yorkshire, England) suffers in 2021 at a race walking competition of all the British
Heart Foundation a cardiac arrest, at 14:10, he himself reported.
(28) Lars Schneider, trainer of TV Braach, retires due to lack of strength after he collapsed with cardiac
arrhythmias during the game of the district league A Hersfeld / Rotenburg against SG
NentershausenWeißenhasel-Solz in Solz and had to be transported to the clinic. Message from 10/14/2021.
(29) Treviso, Italy: 53-year-old AH player suffers a heart attack while training on October 14, 2021 . He could be
kept alive by fellow players.
(30) Australia: 14-year-old student Ava Azzopardi suffers cardiac arrest during the game between Runaway Bay
and Magic United at Surfers Paradise Apollo Soccer Club. She is resuscitated by nine rescue workers, put into an
artificial coma and is now fighting for her life in the hospital. News from October 15, 2021.
(31) At the handball 3G Bundesliga game in Wuppertal between Bergisches HC and HSG Wetzlar on October 16
, 2021 , a spectator with cardiac arrest collapsed not only during the game (this led to the game being
abandoned); after the game, a second spectator also suffered a cardiac arrest .
(32) A 16-year-old boy from Idaho collapses when lifting weights with cardiac arrest. He wakes up after two days
in a coma, but is “extremely confused” and has no short-term memory. News from October 16, 2021.
(33) Camposampiero, Province of Padua, Italy: The 37-year-old doctor Filippo Morando dies while jogging. The
ambulance flown in by helicopter can no longer do anything as it is too late. Message from 10/17/2021.
(34) The Premier League game between Newcastle United and Tottenham FC on October 17, 2021 was
suspended due to a medical emergency in the stands.
(35) Haitem Jabeur Fathallah, 32, a Fortitudo Messina basketball player, suffers cardiac arrest during the game
and dies in hospital. Message from 10/17/2021.
(36) Blumenau, Brazil: Former FC Brusque soccer player from the Brazilian second division, Adans Joao Santos
Alencar (38) , suffers a fatal cardiac arrest in a footvolley tournament. Message from 10/17/2021.
(37) Lombardy, Italy: A 40-year-old cyclist stops because of “medical emergency” on , falls to the ground, is
transported to the hospital by rescue helicopter Rho. Message from 10/17/2021.
(38) Waseem Aslam of Bradford (England) interrupts a game of football suffering from a cardiac arrest. He
could be saved by friends. Message from October 18, 2021.
(39 ) A 26-year-old runner collapses from cardiac arrest in the Detroit Free Press Marathon . Two police officers
rescue him with chest compressions. After that he was treated in the hospital. Message from October 19, 2021.
(40) Cardiac arrhythmias force soccer star Sabrina Soravilla to end her career on October 19 , 2021 after 68
international matches for Uruguay.
(41) Real Murcia’s Antonio López had to retire at the age of 32 due to a heart disease . Message from October 19,
2021.
(42) A 41-year-old amateur soccer player in Brazil dies of cardiac arrest in a game. It happened on October 19,
2021 in Nao-me-toque (Rio Grande do Sul).
(43) Henry, a teenager from Halifax, England, is recognized for saving the life of his 56-year-old father after a
cardiac arrest while jogging in March. Message from October 20, 2021.
(44) At the first division match between Osasuna and Granada in Pamplona on October 22, 2021, a home team
fan suffers cardiac arrest and dies in hospital.
(45) Dieppe, France: A jogger collapses while running with cardiac arrest. He is rescued by two police officers on
the patrol. Message from 10/22/2021.
(46) Acerra (Italy): Remigio Gova. A basketball referee and nurse, in Italy inevitably “vaccinated” against Covid,
at only 30 years of age “died in his sleep”. Message from October 23, 2021.
(47) A double medical emergency at an English stadium on 10/23/2021 during the Championship League game
between West Brom and Bristol City. Defibrillator used, the game had to be postponed twice.
(48) Belgian soccer player (37) suffered cardiac arrest in the locker room after his club’s match on October 24th,
2021, was reanimated but died in hospital.
(49) France: 43-year-old US Montgascon goalkeeper dies of cardiac arrest at half-time. Happened on October
24, 2021 at the La Bâtie-Montgascon stadium.
(50) A 53-year-old suffers a triple cardiac arrest in Bilbao half-marathon and passes away as a result. Message
from October 24, 2021.
(51) Tevita Brice, 28, of Montclair Rugby Football Club, US, collapsed on the pitch with a heart attack. In critical
condition. Message from 10/25/2021.
(52) Fatal cardiac arrest at a mountain running event in the Italian Alps on October 24, 2021. The victim is
Bruno Taffarel (56) from Cordenons.
(53) A cardiac arrest of a player overshadowed the top game of the A2 Dortmund regional soccer league. The
player from SG Gahmen was hospitalized on 10/24/2021. The affected team had played against Eving Selimiye
Spor.
(54) Nocera Umbra, Italy: Sports teacher and soccer coach Mario Mingarelli suffered fatal cardiac arrest during
his team’s game on October 24, 2021 at the age of 69 .
(55) The amateur match between Frugesport (Ravenna) and Vaccolino (Prima Categoria, Girone F) is canceled
after 32 minutes because the “young” referee suffers a medical emergency . Message from 10/26/2021.
(56) 17-year-old Elly Böttcher from Rostocker FC collapsed unconscious during the away game in Hohen
Neuendorf of the Frauen Regionalliga Nordost on October 24, 2021 without any interference and was
transported to the hospital. The game was stopped after the incident.
(57) A 20-year-old Italian collapses when skateboarding with a cardiac arrest and is now fighting for his life in
the hospital in Verona, where he was transported by helicopter. News from October 25, 2021.
(58) A fan of the Belgian second division team from Lier collapsed on October 27, 2021 in the stadium with
heart problems and died in hospital.
(59) On the same day (27.10.2021) also in Belgium, the cup match against Dender of Eupen: A fan collapses
with cardiac arrest and must be revived.
(60) Sassuolo, Italy: A 53-year-old mountain biker suffers fatal cardiac arrest on an off-road tour. Message from
10/27/2021.
(61) England: A fan collapses after the Cup game Stoke City against Brentford on October 27, 2021 in front of
the stadium with cardiac arrest and dies.
(62) A player from Blau-Weiß Linz from Ghana (26) collapses during his club’s home game against Hartberg
and is transported to the hospital. Happened on October 27, 2021 at the round of 16 for the ÖFB-Pokal. He is
diagnosed with a congenital heart rhythm disorder and was helped with a defibrillator.
(63) Pakistan: The 30-year-old player Muhammad Islam from FC Raziq Chaman suffers a heart attack in the
middle of the game against Millat Club and dies. Message from 10/28/2021.
(64) The Swedish-Iraqi player Aimar Sher from the Italian first division club Spezia Calcio collapses during
training and is transported to the hospital. Message from 10/28/2021.
(65) Pennsylvania, USA: A 12-year-old student at Chartiers Valley Middle School collapses while playing
basketball in physical education class without help and dies. Message from 10/28/2021.
(66) Barcelona star Sergio Aguero (33) suddenly gets breathless during the league game against Deportivo
Alaves, grabs his chest and collapses. The Argentine national team player must now take a break of at least three
months. A few months ago he was suffering from a severe Corona infection. Notification from 10/30/2021
(67) During the ICE ice hockey league game, Boris Sadecky (24) from the Bratislava Capitals collapses on the ice without any outside interference. He dies five days later. It later emerges that he suffered from “mild
myocarditis” on match day. Message from 10/30/2021
(68) The student and soccer coach for the La Salle High School team in Pennsylvania, USA Blake Barklage died
after a heart attack over the weekend. Message from 11/1/2021.
(69) Argentina: The soccer player Ronald Biglione dies after the 2nd vaccination due to thrombosis – a wellknown side effect of the vaccinations against which the manufacturers themselves warned about. He was treated in Cordoba hospital for two weeks. Message from November 5, 2021.
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>>> Scientists Found Genetic Mutations in Every Astronaut Blood Sample They Studied
Futurism
by Victor Tangermann
Sep 6, 2022
https://www.msn.com/en-us/health/health-news/scientists-found-genetic-mutations-in-every-astronaut-blood-sample-they-studied/ar-AA11x5hm
When they examined decades-old blood samples from 14 NASA astronauts who flew Space Shuttle missions between 1998 and 2001, researchers found that samples from all 14 astronauts showed mutations in their DNA.
While these mutations are likely low enough not to represent a serious threat to the astronauts' long term health, the research underlines the importance of regular health screenings for astronauts, especially as they embark on longer missions to the Moon and beyond in coming years.
The specific mutations, as identified in a new study published in the journal Nature Communications Biology, were marked by a high proportion of blood cells that came from a single clone, a phenomenon called clonal hematopoiesis.
Mutations like this can be caused by exposure to excess ultraviolet radiation, and other forms of radiation including chemotherapy.
In this case, researchers are suspicious that the mutations may have been the result of space radiation.
"Astronauts work in an extreme environment where many factors can result in somatic mutations, most importantly space radiation, which means there is a risk that these mutations could develop into clonal hematopoiesis," said lead author David Goukassian, professor of medicine at the Icahn School of Medicine at Mount Sinai, in a statement.
The topic of astronaut health is more pertinent than ever before. Just last year, NASA proposed to change the radiation limits its astronauts can be exposed to to protect their health.
In short, the agency is trying to allow younger astronauts to be exposed to relatively higher amounts of radiation than older astronauts, and eliminating the differences in limits between men and women.
The blood samples for this latest study were collected from 12 male and two female astronauts ten days before their flight and on the day of their landing. The samples were then cryogenically stored at -112 degrees Fahrenheit for around two decades.
The mutations observed in the blood samples resemble the kind of somatic mutations we see in older individuals — which is interesting on its own, considering the median age of the astronauts was only 42.
"Although the clonal hematopoiesis we observed was of a relatively small size, the fact that we observed these mutations was surprising given the relatively young age and health of these astronauts," Goukassian said.
"The presence of these mutations does not necessarily mean that the astronauts will develop cardiovascular disease or cancer," he added, "but there is the risk that, over time, this could happen through ongoing and prolonged exposure to the extreme environment of deep space."
Therefore, Goukassian and his team are recommending that NASA should regularly screen astronauts for these kinds of mutations.
Scientists have long speculated about the numerous health risks astronauts face when spending extended periods of time in outer space — and the more we discover, the better we can ensure their safety in the long run.
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>>> Abstract P219: The Vast Majority of People Who Eat “Gluten Free” for IBS, Celiac, or Autoimmune Disease Have Markers of Leaky Gut That Resolve When “Gluten Free” Foods Containing Lectins, Like Corn, Other Grains, Beans, and Nightshades are Removed From Their Diet
Steven R Gundry
https://www.ahajournals.org/doi/10.1161/circ.141.suppl_1.P219#:~:text=Session%2016%20Nutrition-,Abstract%20P219%3A%20The%20Vast%20Majority%20of%20People%20Who%20Eat%20%E2%80%9CGluten,are%20Removed%20From%20Their%20Diet
Originally published 2 Mar 2020
https://doi.org/10.1161/circ.141.suppl_1.P219Circulation. 2020;141:AP219
Abstract
Initial evaluation of pts referred with Irritable Bowel Syndrome, Celiac, and/or autoimmune diseases includes Celiac HLA genetics, Celiac IgA and IgG markers, and autoimmune markers. Most patients are self described as eating a gluten free diet. Increasingly, and with more affordable tests being made available, we have started to use a battery of tests for leaky gut, wheat, corn, lectin, dairy, and egg proteins reactivity/sensitivity from Vibrant Wellness (San Carlos, Ca) called Zoomers.
Leaky gut was determined by Anti-Zonulin IgG and IgA, Anti-Actin IgG and IgA; Wheat sensitivity panels included Transglutaminase, Wheat Germ Agglutinin, Gliadin, Glutenin, and Non-gluten wheat protein IgG and IgA panels. All corn proteins, including the wheat-corn epitope overlap and the GMO Cry proteins IgG and IgA, as well as IgG and IgA reactions to major lectins and aquaporins in beans, squash, spinach, nightshades, corn, and to protein components of dairy and eggs.
We now report results on the first 50 patients, ages 7-76, M:F ratio 1:1, who, following these initial tests, started the lectin limited diet, The Plant Paradox.
Results:
100% of pts were positive for leaky gut (50/50). Forty nine of 50 (98%) were reactive to more than one component of wheat, although only 35/50 (70%) where positive for HLA gluten genes. Seventy percent of pts (35/50) were sensitive to the corn-wheat cross reaction epitope, while 31/50 (62%) reacted to the GMO cry corn protein. Forty nine of 50 (98%) reacted to one or more bean lectins, while 38/50 (76%) reacted to one or more aquaporins in soy, spinach, corn, potatoes, bell peppers. While sensitivities to dairy and egg proteins did occur, they were rare compared to the above proteins.
Retesting has been done in 11 of 50 pts, 2 to 9 months following the first test. Resolution of leaky gut occurred in 10/11 (91%), and reactivity to all wheat proteins as measured by IgG and IgA disappeared, indicating tolerance.
We conclude that most patients following a gluten free diet still have leaky gut with both gluten and wheat antibodies, all of which resolve when a lectin free diet is followed.
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>>> Abstract 706: Dietary Lectins Contribute to Coronary Artery Disease in Humans via an 1L-16 Autoimmune Mediated Response as Shown by the PULS ACS Risk Score
https://www.ahajournals.org/doi/10.1161/atvb.39.suppl_1.706
Steven R Gundry
Originally published19 Jul 2019
Arteriosclerosis, Thrombosis, and Vascular Biology. 2019;39:A706
Abstract
Interleukin 16 (IL-16) is a chemoattractant released by endothelial and other cells to attract activated T cells. It has previously been shown to have expression in many autoimmune diseases (AI). Based on our previous reports using elevated adiponectin levels of 16 ug/mL to predict lectin sensitivity, and showing an association between lectins and AI causation, we have treated a large patient population with known autoimmune disease confirmed by markers. Our continuing hypothesis is that coronary artery disease is an autoimmune process. We reported last year that the PULS Cardiac Test (GD Biosciences Lab, Irvine, CA) a validated blood test for predicting 5 year risk of acute coronary syndrome (ACS), showed that IL-16 elevation was the first or second highest risk factor for ACS in these AI patients. The PULS tests ranks 9 biomarkers, including IL-16, MCP-3, Eotaxin, CTACK, sFas, Fas Ligand, HGF for ACS risk, ranking each biomarker from lowest to highest level contributing to risk.
We subsequently enrolled 278 pts, aged 35 to 91, M/F ratio 1/1, who were positive for elevated IL-16, without AI, and with elevated PULS scores, in our clinical dietary program, The Plant Paradox, which consists of removing major dietary lectins from the diet, including grains, beans, nightshades, peanuts, and using large amounts of olive oil as fat; and measured PULS markers and Risk Score both at baseline and 6 months follow up.
PULS Risk Score at baseline was 23.5+/-8 (normal 4+/-2) with IL-!6 contributing 75% to the risk score. At 6 months, PULS Scores fell to 8+/-5 with IL-16 contributing only 20% to total PULS risk score.
We conclude that based both on IL-16 levels and PULS Scores dramatically falling during six months of lectin avoidance, that this provides further evidence to support an autoimmune contribution to coronary artery disease causation at the endothelial level via T cell activation and attraction, most likely caused by dietary lectins. Removal of dietary lectins reduces risk of ACS and should be recommended nutritional therapy.
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>>> Abstract 137: Reversal of Endothelial Dysfunction Using Polyphenol Rich Foods and Supplements Coupled with Avoidance of Major Dietary Lectins
https://www.ahajournals.org/doi/abs/10.1161/atvb.33.suppl_1.a137
Steven R Gundry and Jean Epstein
Originally published17 Mar 2018
https://doi.org/10.1161/atvb.33.suppl_1.A137
Arteriosclerosis, Thrombosis, and Vascular Biology. 2013;33:A137
Abstract
Endothelial dysfunction (ED) is highly correlated with the development of coronary artery and vascular disease in general. While dietary factors have been previously implicated in the causation of endothelial dysfunction, a purposeful change in dietary habits, coupled with the addition of several polyphenol-containing supplements, has not been studied for their effects on endothelial function, as measured by Peripheral Arterial Tonometry (PAT).
200 consecutive pts, aged 51-86, M:F ratio 3/2, with known vascular risk factors of HTN, DM, Hypercholesterolemia, hx of MI, Stent, CABG, were enrolled in a dietary program, which emphasizes large amts of leafy green vegetables, olive oil, radical reduction of grain, legumes, nightshades, and fruits; and generous amts of grassfed animal proteins, emphasizing Shellfish and avoiding commercial poultry (Diet Evolution). All pts were instructed to take 2-4,000 mg of high DHA fish oil, 200mg of Grape Seed Extract, and 50 mg of Pycnogenol per day. All pts had Endothelial Reactivity (ER) using PAT before and after a 5-minute arm occlusion using the EndoPAT 2000 (Itamar, Israel) at baseline and at 6 months.
Baseline Endothelial Reactivity was 1.88+/-0.7 (range 1.0-3.3), with 145/200 pts (72%) having endothelial dysfunction (less than 1.60). At 6 months, ER increased to 2.25+/-0.5 (range 1.2-3.6) (p<0.01). Only 40/200 (20%) remained with ED, but all had increased ER numbers. Ten pts stopped the polyphenols after a normal PAT; all developed ED on repeat PAT.
We conclude that a limited grain, legume, nightshade, and fruit diet with emphasis on greens, olive oil and grassfed animal proteins, particularly Shellfish, with avoidance of commercial poultry, with supplemental fish oil and polyphenols dramatically improves endothelial function in a group of high risk patients.
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>>> Abstract 309: Twelve Year Follow up for Managing Coronary Artery Disease Using a Nutrigenomics Based Diet and Supplement Program With Quarterly Assessment of Biomarkers
https://www.ahajournals.org/doi/10.1161/atvb.35.suppl_1.309
Steven R Gundry
Originally published 11 Aug 2015
https://doi.org/10.1161/atvb.35.suppl_1.309
Arteriosclerosis, Thrombosis, and Vascular Biology. 2015;35:A309
Abstract
Introduction: Coronary Artery Disease (CAD) is thought to be progressive; standard protocols call for a low fat/low cholesterol diet, exercise, and lipid lowering agents in an effort to slow the onset of recurrent MI’s, stents, CABG’s, stroke, or death. This results in an approximate 30-40% new event rate in 5 yrs.
Methods:
Based upon our experience using a Nutrigenomic-based, Lectin-limited diet to prevent/reverse Metabolic Syndrome and CAD, we have enrolled and followed 978 pts (aged 42-89 yrs) with known CAD, defined as previous MI, stent, CABG, or positive stress test/angiogram, positive Corus score greater than 30, into a diet and supplement based, physician coached program, which emphasizes large amts of leafy green vegetables, olive oil, radical reduction of grain, legumes, nightshades, and fruits; and 4 oz amts of animal proteins, emphasizing shellfish, wild fish, and grass fed meats, while avoiding commercial poultry (Matrix Protocol). All Apo E 4 genotypes ate large amts of shellfish and avoided animal fats and cheeses. All pts were instructed to take 2-4,000 mg of high DHA fish oil, 200mg of Grape Seed Extract, and 50 mg of Pycnogenol per day. Supplements were individualized based on results of Advanced Cardiovascular Risk Markers, which were sent to three core labs, (Berkeley Heart Labs, and Singulex, Alameda, CA, Health Diagnostics Labs, Richmond,VA) q 3 months and followed to measure compliance and to change supplement/eating regimens.
Results: Pts have been followed for 1.5 to 12 years (mean 9 yrs). While enrolled, 13/978 pts (1.3%) have received a new stent, two that were predicted by a rising Lp-PLA2, two required CABG, based on a rising Corus score, despite HDL’s of 110-120 mg/dl. There have been no MI’s, unstable angina. One pt underwent carotid endarterectomy ; one pt suffered a CVA and died, while in atrial fibrillation, A second pt expired from a ruptured cerebral berry aneurysm. Total CV events over 12 years is 16/978 (1.6%).
Conclusions: We conclude that simple Nutrigenomic-based dietary interventions, emphasizing lectin avoidance, with compliance and supplement choices based upon q 3 month assessment of biomarkers, represents a quantum leap forward in preventing/modifying Cardiovascular events in known CAD patients.
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>>> Abstract P238: Remission/Cure of Autoimmune Diseases by a Lectin Limited Diet Supplemented With Probiotics, Prebiotics, and Polyphenols
https://www.ahajournals.org/doi/abs/10.1161/circ.137.suppl_1.p238?cookieSet=1
Steven R Gundry
Originally published 29 Jun 2018
https://doi.org/10.1161/circ.137.suppl_1.p238
Circulation. 2018;137:AP238
Abstract
All autoimmune diseases are highly associated with increased rates of coronary artery and vascular disease secondary to immune cell attack on epithelial cells. The causes of autoimmune disease (AID) seem to be multifactorial. However, the idea that derangement of the microbiome, breaches of the intestinal barrier (leaky gut) and introduction into the human diet of plant defense molecules such as lectins, which are capable of molecular mimicry, prompted our group to investigate the application of a lectin limited diet, coupled with probiotics and prebiotics (The Pant Paradox Protocol) to impact biomarker proven autoimmune disease activity in humans and their impact on endothelial biomarkers of inflammation.
One hundred and two consecutive patients with immunoassay markers of autoimmune disease activity, i.e., RF, anti-CCP, ANA, Histone, etc, and signs and symptoms of RA, Lupus, Sjogrens, Crohns, Colitis, Scleroderma, Mixed Connective Tissue Disease, and biomarkers of endothelial inflammation, were enrolled into a program of elimination of major dietary lectins, consisting of all grains and pseudo grains, beans and legumes, peanuts, cashews, nightshades, squashes, and Casein A1 milk products (The Plant Paradox Program), supplemented with probiotics and prebiotics including resistant starches and polyphenol supplements. All pts initially low Vit D levels and low Omega 3 index and adiponectin levels above 16mg/dl. Biomarkers of inflammation, hs-CRP, TNF-alpha, IL-6, fibrinogen, myeloperoxidase and autoimmune markers were measured every 3 months.
95/102 patients achieved complete resolution of autoimmune markers and inflammatory markers within 9 months. The other 7/102 patients all had reduced markers, but incomplete resolution. 80/102 patients were weaned from all immunosuppressive and/or biologic medications without rebound.
We conclude that a lectin limited diet, supplemented with pro and prebiotics, and polyphenols are capable of curing or putting into remission most autoimmune diseases.
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>>> FDA approves first fast-acting oral drug for clinical depression
The Hill
by Gianna Melillo
August 22, 2022
https://www.yahoo.com/news/fda-approves-first-fast-acting-173748042.html
A newly approved treatment for clinical depression is being hailed as a potential game changer for the millions of Americans who suffer from the condition.
Auvelity, from Axsome Therapeutics, marks the first drug with a different mechanism of action approved for treating depression in 60 years.
In clinical trials, participants reported progress beginning at week one and sustained benefits throughout the study window.
A newly approved drug from Axsome Therapeutics, Auvelity, can improve symptoms of major depressive disorder (MDD) — also known as clinical depression — after one week of administration, making it the first and only oral rapid-acting drug approved for the disorder.
The drug’s mechanism is also novel and marks the first new type of medication to be approved for the condition in 60 years. Auvelity was granted Breakthrough Therapy Designation following a priority review by the Food and Drug Administration (FDA).
The announcement comes on the heels of a new review that found serotonin levels or activity are likely not the cause of depression, challenging a long-held belief the condition is the result of brain chemical imbalances and opening a window for new research on different potential treatments.
Common medicines on the market for those with MDD include selective serotonin reuptake inhibitors (SSRIs), such as Zoloft, and serotonin-norepinephrine reuptake inhibitors (SNRIs), like Cymbalta, for example, among others.
Trial results showed the positive benefits of Auvelity, an N-methyl D-aspartate (NMDA) receptor antagonist, were sustained at all time points assessed, although its exact mechanism of action in MDD remains unclear. It will become available to patients in the fourth quarter of 2022.
“The approval of Auvelity represents a milestone in depression treatment based on its novel oral NMDA antagonist mechanism, its rapid antidepressant efficacy demonstrated in controlled trials, and a relatively favorable safety profile,” said Maurizio Fava of Massachusetts General Hospital in a press release. Fava is also a Slater Family professor of psychiatry at Harvard Medical School.
The treatment comes at an opportune time as many Americans continue to suffer poor mental health outcomes resulting from the COVID-19 pandemic.
Prior to COVID-19, “over 20 million American adults experienced major depressive disorder each year,” said Michael Pollock, Chief Executive Officer of the Depression and Bipolar Support Alliance, in the release.
But research from Brown University, published in October 2021, found depression rates tripled during the first year of COVID-19 alone, while recent economic woes, global conflict and a contentious political landscape, coupled with a shortage of mental health care providers, can all compound poor outcomes.
“Nearly two thirds of patients treated with currently available antidepressants do not adequately respond, and those that do may not achieve clinically meaningful responses for up to six to eight weeks,” Fava said. “Given the debilitating nature of depression, the efficacy of Auvelity observed at one week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition.”
The FDA approval is based on a clinical trial program that tested the medication in more than 1,100 adults with depression. In addition to being superior to placebo, an additional study found the treatment superior to 150mg sustained release tablets of bupropion, a norepinephrine and dopamine reuptake inhibitor (NDRI).
Common adverse effects associated with Auvelity included dizziness, headache, diarrhea and dry mouth, among others.
“With symptom improvement happening at week one and then remission happening by week two, the combination of those two is incredibly differentiating in the marketplace right now,” said Lori Englebert, executive vice president of Axsome’s commercial and business development, in a statement. “We’re pretty excited about the product.”
The company hopes to set the price for the treatment in the coming weeks.
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>>> Top 10 Prescription Drugs That Cost Medicare the Most
By Dena Bunis
AARP
https://www.aarp.org/politics-society/advocacy/info-2022/medicare-prescription-drug-costs.html
AARP research finds brand-name manufacturers still increasing prices
1. Eliquis
Use: A blood thinner for people with atrial fibrillation (A-fib)
Medicare spending in 2020: $9.9 billion
Number of beneficiaries: 2,641,941
January 2022 price increase: 6 percent
2. Revlimid
Use: To treat cancer
Medicare spending in 2020: $5.4 billion
Number of beneficiaries: 43,747
January 2022 price increase: 4.5 percent
3. Xarelto
Use: A blood thinner for people with atrial fibrillation (A-fib)
Medicare spending in 2020: $4.7 billion
Number of beneficiaries: 1,184,718
January 2022 price increase: 4.9 percent
4. Januvia
Use: To treat diabetes
Medicare spending in 2020: $3.9 billion
Number of beneficiaries: 934,686
January 2022 price increase: 5 percent
5. Trulicity
Use: To treat diabetes
Medicare spending in 2020: $3.3 billion
Number of beneficiaries: 497,327
January 2022 price increase: 5 percent
6. Imbruvica
Use: To treat cancer
Medicare spending in 2020: $3 billion
Number of beneficiaries: 26,847
January 2022 price increase: 7.4 percent
7. Jardiance
Use: To treat diabetes
Medicare spending in 2020: $2.4 billion
Number of beneficiaries: 594,859
January 2022 price increase: 4 percent
8. Humira (Cf) pen
Use: To treat rheumatoid arthritis, plaque psoriasis
Medicare spending in 2020: $2.2 billion
Number of beneficiaries: 42,406
January 2022 price increase: 7.4 percent
9. Ibrance
Use: To treat cancer
Medicare spending in 2020: $2.1 billion
Number of beneficiaries: 21,394
January 2022 price increase: 6.9 percent
10. Symbicort
Use: To treat asthma
Medicare spending in 2020: $2 billion
Number of beneficiaries: 1,017,530
January 2022 price increase: 2 percent
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NIH - >>> Antiviral Nasal Spray Shows Promise Fighting COVID-19
National Institutes of Health
https://covid19.nih.gov/news-and-stories/antiviral-nasal-spray-shows-promise-fighting-covid-19
Nasal sprays may be a promising first line of defense against SARS-CoV-2 infection.
What you need to know
Prevention is the best medicine, and COVID-19 vaccines block most SARS-CoV-2 infections. But vaccines are fighting a changing opponent. New methods of fast-acting COVID-19 prevention are being researched to make it safer to be in large public gatherings like sporting events or concerts.
Researchers supported in part by the National Institute of Allergy and Infectious Diseases (NIAID) have developed a nasal spray that has the potential to not only treat COVID-19 but also prevent SARS-CoV-2 infection in a way that the virus can’t mutate to avoid. The experimental drug works in mice, and researchers believe it may be effective in humans.
What did the researchers do?
Researchers have looked for ways to prevent SARS-CoV-2 infection that the virus can’t learn to dodge or evade by mutating. To infect a cell, the virus tricks several of that cell’s proteins, including one called TMPRSS2, to gain entry. Researchers began to work on compounds that stifle TMPRSS2’s ability to interact with the viral protein.
The researchers picked four compounds that worked at very low concentrations and did not negatively affect the host cells. Those compounds were tested in human lung and colon cells that were then exposed to SARS-CoV-2. The most promising compound, N-0385, virtually stopped infection in its tracks. Because N-0385 was suitable for use as a nasal spray, researchers used a mouse model that develops severe COVID-19 and gave the mice either N-0385 or control doses of saline in their noses.
The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. When treated with N-0385, 70% of the mice survived and had little to no lung damage. When the treatment course was shortened to four days, starting one day before infection, all 10 of the mice treated with N-0385 survived. Only one of the 20 mice given saline survived.
Mice treated with just a single dose of N-0385 on the day they were infected had a high survival rate as well.
Why is this research important?
COVID-19 vaccines teach the immune system to recognize a particular protein on SARS-CoV-2 that is known as the spike protein. But the spike protein may mutate to evade immune response.
TMPRSS2 is a protein in mouse and human cells that SARS-CoV-2 uses as a gateway to infect humans. By blocking that access, compounds that target TMPRSS2 have the potential to be effective against both current and future variants.
Because we get infected with SARS-CoV-2 primarily by breathing it in, a nasal spray might be an easy and efficient way to offer protection against the virus, especially in crowded places. Researchers plan to continue testing the timing of when N-0385 should be administered and to expand testing into human clinical trials.
Where can I go to learn more?
Nasal antiviral blocks SARS-CoV-2 infection in mice
More information about the results of the study, which was funded in part by NIAID.
Finding Effective Treatments for SARS-CoV-2 Variants
The Coronavirus Immunotherapy Consortium identified new candidate drugs based on monoclonal antibodies in work funded by NIAID.
Understanding the Range of Reactions to SARS-CoV-2
In a study funded by NIAID, researchers are using mice to look for genes that account for different COVID-19 symptoms.
Sources
Lee, K. (2022, April 27). Cornell research team to develop COVID-19 nose spray treatment. Cornell Daily Sun. https://cornellsun.com/2022/04/27/cornell-research-team-to-develop-covid-19-nose-spray-treatment/
Shapira, T., Monreal, I. A., Dion, S. P., Buchholz, D. W., Imbiakha, B., Olmstead, A. D., Jager, M., Désilets, A., Gao, G., Martins, M., Vandal, T., Thompson, C. A. H., Chin, A., Rees, W. D., Steiner, T., Nabi, I. R., Marsault, E., Sahler, J., Diel, D. G., . . . Jean, F. (2022). A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. Nature, 10.1038/s41586-022-04661-w. Advance online publication. https://doi.org/10.1038/s41586-022-04661-w
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>>> Stiff, achy knees? Lab-made cartilage gel outperforms the real thing
Duke Today
Aug 11, 2022
https://today.duke.edu/2022/08/lab-made-cartilage-gel-outperforms-real-thing
Human clinical trials may begin as soon as next year.
Duke researchers have developed a gel-based cartilage substitute to relieve achy knees that’s even stronger and more durable than the real thing. Clinical trials to start next year.
DURHAM, N.C. -- Over-the-counter pain relievers, physical therapy, steroid injections -- some people have tried it all and are still dealing with knee pain.
Often knee pain comes from the progressive wear and tear of cartilage known as osteoarthritis, which affects nearly one in six adults -- 867 million people -- worldwide. For those who want to avoid replacing the entire knee joint, there may soon be another option that could help patients get back on their feet fast, pain-free, and stay that way.
Writing in the journal Advanced Functional Materials, a Duke University-led team says they have created the first gel-based cartilage substitute that is even stronger and more durable than the real thing.
Mechanical testing reveals that the Duke team’s hydrogel -- a material made of water-absorbing polymers -- can be pressed and pulled with more force than natural cartilage, and is three times more resistant to wear and tear.
Implants made of the material are currently being developed by Sparta Biomedical and tested in sheep. Researchers are gearing up to begin clinical trials in humans next year.
“If everything goes according to plan, the clinical trial should start as soon as April 2023,” said Duke chemistry professor Benjamin Wiley, who led the research along with Duke mechanical engineering and materials science professor Ken Gall.
A hydrogel-based implant could replace worn-out cartilage and alleviate knee pain without replacing the entire joint.
To make this material, the Duke team took thin sheets of cellulose fibers and infused them with a polymer called polyvinyl alcohol -- a viscous goo consisting of stringy chains of repeating molecules -- to form a gel.
The cellulose fibers act like the collagen fibers in natural cartilage, Wiley said -- they give the gel strength when stretched. The polyvinyl alcohol helps it return to its original shape. The result is a Jello-like material, 60% water, which is supple yet surprisingly strong.
Natural cartilage can withstand a whopping 5,800 to 8,500 pounds per inch of tugging and squishing, respectively, before reaching its breaking point. Their lab-made version is the first hydrogel that can handle even more. It is 26% stronger than natural cartilage in tension, something like suspending seven grand pianos from a key ring, and 66% stronger in compression -- which would be like parking a car on a postage stamp.
“It’s really off the charts in terms of hydrogel strength,” Wiley said.
The team has already made hydrogels with remarkable properties. In 2020, they reported that they had created the first hydrogel strong enough for knees, which feel the force of two to three times body weight with each step.
Putting the gel to practical use as a cartilage replacement, however, presented additional design challenges. One was achieving the upper limits of cartilage’s strength. Activities like hopping, lunging, or climbing stairs put some 10 Megapascals of pressure on the cartilage in the knee, or about 1,400 pounds per square inch. But the tissue can take up to four times that before it breaks.
“We knew there was room for improvement,” Wiley said.
In the past, researchers attempting to create stronger hydrogels used a freeze-thaw process to produce crystals within the gel, which drive out water and help hold the polymer chains together. In the new study, instead of freezing and thawing the hydrogel, the researchers used a heat treatment called annealing to coax even more crystals to form within the polymer network.
By increasing the crystal content, the researchers were able to produce a gel that can withstand five times as much stress from pulling and nearly twice as much squeezing relative to freeze-thaw methods.
The improved strength of the annealed gel also helped solve a second design challenge: securing it to the joint and getting it to stay put.
Cartilage forms a thin layer that covers the ends of bones so they don’t grind against one another. Previous studies haven’t been able to attach hydrogels directly to bone or cartilage with sufficient strength to keep them from breaking loose or sliding off. So the Duke team came up with a different approach.
Their method of attachment involves cementing and clamping the hydrogel to a titanium base. This is then pressed and anchored into a hole where the damaged cartilage used to be. Tests show the design stays fastened 68% more firmly than natural cartilage on bone.
“Another concern for knee implants is wear over time, both of the implant itself and the opposing cartilage,” Wiley said.
Other researchers have tried replacing damaged cartilage with knee implants made of metal or polyethylene, but because these materials are stiffer than cartilage they can chafe against other parts of the knee.
In wear tests, the researchers took artificial cartilage and natural cartilage and spun them against each other a million times, with a pressure similar to what the knee experiences during walking. Using a high-resolution X-ray scanning technique called micro-computed tomography (micro-CT), the scientists found that the surface of their lab-made version held up three times better than the real thing. Yet because the hydrogel mimics the smooth, slippery, cushiony nature of real cartilage, it protects other joint surfaces from friction as they slide against the implant.
Natural cartilage is remarkably durable stuff. But once damaged, it has limited ability to heal because it doesn’t have any blood vessels, Wiley said.
In the United States, osteoarthritis is twice as common today than it was a century ago. Surgery is an option when conservative treatments fail. Over the decades surgeons have developed a number of minimally invasive approaches, such as removing loose cartilage, or making holes to stimulate new growth, or transplanting healthy cartilage from a donor. But all of these methods require months of rehab, and some percentage of them fail over time.
Generally considered a last resort, total knee replacement is a proven way to relieve pain. But artificial joints don’t last forever, either. Particularly for younger patients who want to avoid major surgery for a device that will only need to be replaced again down the line, Wiley said, “there just aren't very good options out there.”
“I think this will be a dramatic change in treatment for people at this stage,” Wiley said.
This work was supported in part by Sparta Biomedical and by the Shared Materials Instrumentation Facility at Duke University. Wiley and Gall are shareholders in Sparta Biomedical.
CITATION: "A Synthetic Hydrogel Composite With a Strength and Wear Resistance Greater Than Cartilage," Jiacheng Zhao, Huayu Tong, Alina Kirillova, William Koshut, Andrew Malek, Natasha Brigham, Matthew Becker, Ken Gall, and Benjamin Wiley. Advanced Functional Materials, Aug. 4, 2022. DOI: 10.1002/adfm.202205662
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>>> What a blood transfusion experiment in mice can teach us about aging
Medical News Today
by Deep Shukla
August 13, 2022
https://www.medicalnewstoday.com/articles/what-a-blood-transfusion-experiment-in-mice-can-teach-us-about-aging
Scientists transfused blood from old mice into young ones in a bid to better understand how to mitigate the effects of aging. One of the hallmarks of aging includes senescence, a state in which cells stop growing and dividing.
A new study shows that receiving a single blood transfusion from old mice caused the aging of tissue in young mice. Treatment of older mice with senolytic agents, which are drugs that eliminate senescent cells, before blood transfusions to young mice reduced the levels of senescence markers in young mice.
The study shows that senescence can occur not only due to wear and tear associated with aging but also bloodborne factors.
The identification of factors in the blood of aged animals that induce aging could help develop therapeutics that slow down aging
Study author Dr. Irina Conboy, a professor at the University of California Berkeley, told Medical News Today:
“[Our study shows that] cellular senescence is neither cell intrinsic nor a purely chronological — damage accumulation phenomenon; it can be quickly induced in 2 weeks in young animals. Senolytics only partially reduce the negative effects of old blood on young cells and tissues, suggesting additional therapeutic avenues.”
Dr. Conboy added that this study further substantiates the role of factors in old blood in promoting aging.
Causes of cellular aging
Cells tend to respond to injury or stress by either undergoing cell death or entering a state where they stop multiplying. This state in which cells stop growing and dividing is known as cellular senescence.
In addition to external stimuli such as stress, intrinsic factors such as changes in DNA structure with aging can also cause senescence.
Upon undergoing senescence, cells can send signals to the immune system, facilitating their removal by immune cells.
A gradual decline in the ability of the immune system to remove these senescent cells occurs with aging, resulting in the accumulation of senescent cells. The accumulation of senescent cells contributes to the aging of organs and is associated with chronic diseases.
Senescent cells can also secrete molecules that signal neighboring cells to also undergo senescence. These molecules secreted by senescent cells, known as the senescence-associated-secretory phenotype (SASP), include pro-inflammatory proteins and other factors that remodel the neighboring tissue.
However, the influence of these factors secreted by senescent cells in promoting aging is not well understood.
Evidence from previous studies suggests that molecules or cells present in older animals can induce tissue in younger animals to undergo aging.
For instance, studies have shown that surgically joining a young mouse with an older one can rejuvenate the tissue in the older mouse. At the same time, this procedure results in the aging of the tissue in the younger animal.
Besides having a common circulatory system, the surgically joined animals also share organs and are exposed to a similar environment. This makes it hard to single out the potential source of the pro-aging or rejuvenating factors.
Likewise, blood transfusion from aged mice to younger mice can cause tissue in the younger animal to age. These studies suggest that certain factors present in the blood of older mice can induce aging in their younger counterparts. However, whether these pro-aging effects of old blood are due to senescent cells is not known.
In the present study, the researchers examined whether senescence could be transferred from older mice to younger ones through blood transfusions.
Blood transfusions and senescence
To assess the ability of old blood to induce senescence, the authors transfused blood from aged mice (22-24 months) to their younger counterparts (3 months). The control group consisted of young rats (3 months) receiving blood transfusions from other young rats of the same age.
At 14 days after receiving the blood transfusion, the young mice receiving blood from the older mice showed increased expression of senescence biomarkers in the muscle, kidney, and liver. However, such an increase in the levels of senescence markers was absent in the lungs, heart, and brain.
The young mice that received blood transfusions from older mice also showed deficits in tasks assessing muscle strength and exhibited lower physical endurance.
Similar to skeletal muscle tissue, young mice receiving blood from older mice also showed elevated levels of biomarkers for tissue damage and impaired or suboptimal function in the liver and the kidney.
The researchers also transfused blood from younger mice to older mice and found that receiving young blood decreased tissue damage in the liver, kidney, and muscles of old mice.
In sum, these results suggest induction of senescence in young mice after receiving blood transfusions from older mice. Moreover, senescence induced in young animals after receiving blood from old mice was tissue-specific.
The effects of senolytics
The researchers then investigated whether the elimination of senescent cells in aged mice could prevent the induction of senescence in young mice after blood exchange.
For this experiment, the researchers maintained the older mice on a regimen of senolytic drugs that eliminate senescent cells for around 4-6 weeks. As expected, treatment with the senolytic drugs reduced the levels of secreted factors associated with senescence in the plasma of the old mice.
The researchers then transfused blood from older mice treated with either senolytic drugs or a vehicle to young mice.
Young mice receiving blood from older mice treated with senolytics showed reduced expression of senescence markers in the muscle, liver, and kidneys than young mice receiving vehicle-treated old blood.
Treatment with senolytics also attenuated the decline in liver, muscle, and kidney function and reduced the damage to these organs in young mice receiving old blood.
Moreover, administration of senolytics to older mice also reduced the adverse effects of old blood on physical activity levels and energy balance in young mice.
Young mice receiving blood from older mice treated with senolytic drugs also showed lower levels of proteins associated with inflammation, a hallmark of senescence.
However, young mice receiving blood from senolytic-treated old mice did show some negative effects associated with the transfusion of old blood. For instance, the administration of senolytics to old mice before the blood transfer failed to prevent some of the negative effects on kidney function in young mice.
These experiments show that the clearance of senescent cells in older mice attenuated the pro-aging effects of the transfer of old blood to young mice. In other words, besides being caused by stress or aging, senescence can also occur due to exposure to factors present in old blood.
Further research is necessary to identify the factors — such as molecules, organelles, or senescent cells themselves — present in the blood that were responsible for the induction of senescence in young mice.
Senescent cells secrete a number of signaling molecules in the circulation and these molecules might, at least in part, be responsible for the induction of senescence. The identification of these factors could help develop therapeutics to retard the aging process.
Study implications
Dr. James Kirkland at the Mayo Clinic Kogod Center on Aging told us:
“[This is an] interesting study that supports the effectiveness of senolytics in alleviating age-related dysfunction. It confirms and extends previous findings that transplanting senescent cells from old into young animals causes dysfunction and that removing those senescent cells from the transplanted mice restores function as well as the finding that transplanting hearts from old into young mice causes the spread of senescence and dysfunction in the young mice while transplanting hearts from young into young mice does not.”
The results of this study raise several interesting questions about aging and potential treatments for slowing down the aging process.
Dr. Stefan Tulius, director of the Transplant Surgery Research Laboratory at Brigham and Women’s Hospital noted that “[a]s any great scientific contribution, this study raises many open questions in addition to providing us with a most relevant aspect on an improved understanding of aging and the potential of increasing health life-span.”
“Those open questions relate particularly to the clinical relevance of the predominantly experimental findings: How much blood will need to be transferred to observe effects? Will a single human blood transfusion make a difference, or will the blood exchange need to go significantly beyond that? For how long will the effects last? Will they be reversible and ‘only’ temporary?”
“The authors report on changes that included long-lasting end-organ damage with scarring in livers and kidneys,” Dr. Tulius added.
“Understanding the mechanisms involved in this process may be most interesting and revealing. Interestingly also, functional effects including compromised physical activities have been observed in mice. Will those be long-lasting or just temporary? Moreover, if physical capacities are compromised, can we then also expect cognitive compromises? Indeed, the authors present fascinating findings raising many intriguing open questions that may guide us to understand aging better and to develop novel approaches facilitating healthy aging,” he went on to note.
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>>> Which microbes live in your gut? A microbiologist tries at-home test kits to see what they reveal about the microbiome
MSN.com
Benjamin Wolfe, Associate Professor of Biology, Tufts University
https://www.msn.com/en-us/news/technology/which-microbes-live-in-your-gut-a-microbiologist-tries-at-home-test-kits-to-see-what-they-reveal-about-the-microbiome/ar-AA10FYio?ocid=mailsignout&li=BBnbfcL
When you hear about the gut microbiome, does it ever make you wonder what tiny creatures are teeming inside your own body? As a microbiologist who studies the microbiomes of plants, animals and people, I’ve watched public interest in gut microbes grow alongside research on their possible dramatic influence on human health. In the past several years, microbiome testing techniques used by researchers like me are now available to consumers at home. These personal gut microbiome testing kits claim to tell you what organisms live in your gut and how to improve your gut microbiome using that data.
You and the trillions of microbes in your gut can live in harmony.
I became very interested in how these home test kits work, what kind of information they provide and whether they can really help you change your gut microbiome. So I ordered a few kits from Viome, Biohm and Floré, tried them out and sifted through my own microbiome data. Here is what I learned.
How do gut microbiome kits work?
All gut microbiome kits require you to carefully collect fresh fecal material. You put it in the various tubes provided in the kit and mail the samples back to the company. Several weeks later, you’ll receive a report describing the types of microbes living in your gut and suggestions on how to change your diet or activities to potentially alter your gut microbiome.
What consumers don’t exactly know is how companies generate the microbial profile data from your fecal sample. A typical approach I and other microbiome researchers use is to extract and decode the microbial genetic material from a sample. We use that genetic material to identify what species of microbes are present. The challenge is that this process can be done in many different ways, and there are no widely agreed-upon standards for what is the best method.
For example, microbiome analyses can be done on two types of genetic material, RNA or DNA. If the profile is based on DNA, it can give you a snapshot only of what types of microbes are present, not what microbial genes are active or what activities they are doing in your body. On the other hand, if the profile is based on RNA, it can tell you not only what microbes are present, but also whether they’re playing a role in your digestion or producing metabolites that can reduce gut inflammation, among other functions. Viome generates its profiles by looking at RNA, while the other companies use DNA.
Other data analysis choices, such as how different types of genetic sequences are sorted or which databases are used to identify the microbes, can also affect the level of detail and utility of the final data. Microbiome scientists are usually very careful to point out these nuances when interpreting their own data in scientific papers, but these details are not clearly presented in home microbiome kits.
What I learned about my gut microbiome
Though I used the same fecal sample for each kit, mixed well to ensure uniformity, I was surprised that each of the three products I tried gave me different impressions of my gut microbiome.
Each company gives an overall “score” on how your microbiome compares with what they consider to be “good” or “healthy.” My scores ranged from 39% (not great) to 72% (good). Interestingly, Viome, which infers microbial activity by using RNA, gave the lowest score. It noted that certain microbial activities happening in my gut, such as methane production and digestion efficiency, were not optimal.
I was also surprised by the variation in total microbial diversity each company reported. While there was general agreement in the overall groups of microbes present at the phylum level, a more general biological grouping, there was a huge range of variation at the species level, the most specific grouping. One company reported 527 species of microbes in my microbiome, while another reported 312. One reported only 27.
Organisms like microbes can be classified into groups of relatedness, from highly specific (species) to very general (kingdom).
Perhaps the most surprising most surprising finding was that my gut may harbor a microbe that could (there are many caveats here!) pose a problem for me in the future if I experience certain medical situations. Even though all companies explicitly looked for this microbe in my gut microbiome sample, only two actually found it. While I won’t name the exact microbe to protect my health privacy, I am not too worried about this result because more information, such as full genome sequencing of the microbe, is needed to better understand if this is actually a concerning strain of this microbe. But this finding does point to some surprising variation in results across different testing kits.
Can this data really improve your gut microbiome?
Many microbiome scientists like me would probably argue that the data these kits provide are limited in terms of giving you the power to alter your health. This is partly because gut microbiome science is still a new field with many unanswered questions.
One challenge is that different people can have different proportions of microbes present in their gut. This variation has made it difficult for scientists and health professionals to agree on what type of microbial community makes a gut “healthy.” Some specific species, such as the bacterium C. diff, and some broad groups, like Proteobacteria, are usually considered undesirable in high amounts. But there is no clear consensus on why one microbiome might be better than another.
Even if you did try to improve your gut microbiome based on what your gut test told you, the results might not turn out as you hoped. Probiotics or diet changes can alter the diversity of your gut microbiome and how it functions, but studies often find that each person can have different responses to these interventions, possibly because of their own unique microbiome composition. The personalized ecology of gut microbial communities, combined with genetics, diet and other factors, makes it challenging to prescribe universal solutions.
So why bother getting a gut microbiome test? For me, it was illuminating to learn what microbes I carry around with me each day. When I eat my lunch, go for a run or get stressed out, the microbes in my gut respond to changes in my body. Researchers may not completely understand what those changes mean and how to manage our microbial partners, but getting to know who they are is a great first step.
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>>> Johnson & Johnson to spin out consumer health business in new publicly traded company
Fierce Pharma
By Kevin Dunleavy
Nov 12, 2021
https://www.fiercepharma.com/pharma/johnson-johnson-to-separate-its-consumer-health-business-create-new-publicly-traded-company
Johnson & Johnson's decision to hive off its consumer health products follows the lead of companies such as Merck, Pfizer, Sanofi and GlaxoSmithKline.
Continuing a trend, especially among the largest firms in the pharmaceutical industry, Johnson & Johnson will form a new publicly traded company to handle its consumer health business, it announced Friday.
This is a particularly significant step for J&J, which has become readily associated with signature products such as Neutrogena, Aveeno, Tylenol, Listerine, Band-Aid and Johnson & Johnson’s Baby Powder. Those brands will fuel the new company along with popular allergy medicine Zyrtec.
The separation will take 18 to 24 months, J&J said.
The move mirrors similar initiatives by companies such as Merck, Sanofi, Pfizer and GlaxoSmithKline, which separated their consumer health products to focus on the highly profitable pharmaceutical business.
Joaquin Duato, announced recently as the successor to departing CEO Alex Gorsky, will continue to lead J&J after the separation. Leadership for the new company will be determined later, J&J said.
“Our board and executive team have regularly evaluated Johnson & Johnson’s portfolio of business over the years, asking whether a broad-based approach best meets the needs of our stakeholders," Gorsky said in an investor call today (Nov. 12). "And while this approach has historically served us well, addressing the complexity of today’s global healthcare and consumer environments now demands unprecedented innovation, focus and agility."
Even after the separation of its consumer health unit—expected by the company to generate $15 billion in revenue this year—J&J will remain a powerhouse as it expects its pharma and medical device units to make $77 billion in 2021.
"We'll remain the world's largest healthcare company, and we'll be highly diversified," said Duato, who added that the new structure would give both units "advantages operationally" that would help "accelerate growth on both sides."
As for the timing of the move, Gorsky said that the pandemic created more urgency for the company to split as people became more concerned with personal health and wellness.
"We felt this was the right time to recognize the differences between the consumer-facing business versus that in our medical device and pharmaceuticals," Gorsky said. "These have evolved as fundamentally different businesses. If you look at the rate and pace of innovation, the level of science and technology involved in pharmaceutical and medical devices, if you look at the investment required in clinical development plans, if you look at the regulatory pathways ... these two businesses share many more common themes versus our consumer business."
The move will allow J&J to concentrate on developing treatments for oncology and immunology and advance new efforts in cell and gene therapy. Additionally, the company said it expects its medical devices business to “accelerate its momentum across orthopedics, interventional solutions, surgery and vision.”
"This business will have four billion-dollar brands, more than 20 brands over $150 million, so it's a very diverse portfolio," Gorsky said of the new spinout. "We think this business is really positioned well. This is from a position of strength."
Gorsky added that J&J's approach to mergers and acquisitions would remain consistent. He said that the company's current pipeline shows a balanced approach, with equal parts external and internal sourcing.
"We definitely tend to have an appetite for smaller tuck-in acquisitions versus large acquisitions. We would expect that to continue," Gorsky said. "There's a lot of emerging areas of science that we'll continue to watch closely and ultimately source that kind of innovation in value-creating ways."
Goldman Sachs and J.P. Morgan will assist J&J in the transition. The planned organizational design will be complete by the end of 2022. Employees assigned to the new company will participate in their current pay, benefits and retirement programs through the end of 2022, J&J said.
The industry trend of major companies separating their consumer health units picked up steam in 2018 when several made moves. The same year, however, J&J doubled down on remaining intact.
Instead of selling off, it agreed to pay 230 billion Japanese yen ($2.0 billion) to acquire the remaining share of Japanese cosmetics and skincare specialist Ci:z. The move gave J&J popular medical cosmetic products Dr.Ci: Labo, Labo Labo and Genomer and additional heft in Japan and other Asian markets. Moreover, instead of distancing consumer from pharma, in June J&J put the two units under one leader, former pharma chief Duato.
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>>> Deadly Tropical Bacteria Found in Continental U.S. Soil for the First Time
CDC officials documented melioidosis-causing bacteria in Mississippi. Two people were hospitalized and developed sepsis.
Gizmodo
By Ed Cara
https://gizmodo.com/melioidosis-bacteria-found-in-us-first-time-cdc-1849343204
A bacteria endemic to tropical areas that causes a life-threatening infection has just been detected within the soil and waters of the continental U.S. for the first time. On Wednesday, the Centers for Disease Control and Prevention reported that they recently isolated Burkholderia pseudomallei bacteria in southern Mississippi. At least two local cases of the serious infection it causes, known as melioidosis, have been traced back to the bacteria found there as well, though both victims have since recovered.
The discovery was announced in a health advisory released to doctors Wednesday afternoon by the CDC.
CDC and local health officials had been conducting an investigation into the two cases, one documented in July 2020 and the other in May 2022. Both patients had no recent travel history to endemic areas, but did live fairly close to one another in the Gulf Coast region of Mississippi. With the patients’ permission, health officials were allowed to sample the soil and water near their properties. In three samples that were collected from the 2020 patient’s home in June 2022, the investigators found B. pseudomallei. Further testing showed that the bacteria found in the environment had a clear genetic resemblance to the bacteria found in both patients, and that none of the samples looked quite like the strains found in other areas of the world. The patients were hospitalized and developed sepsis, but did eventually beat back the infection.
Given the overwhelming evidence, the CDC said in its advisory, “the bacteria in the environment was the likely source of infection for both patients and has been present in the area since at least 2020.”
The rod-shaped B. pseudomallei is abundantly found in the soil and water of warmer regions. Humans exposed to it don’t always become sick, but it’s a very difficult infection to diagnose even when symptoms do happen. Many signs of illness are nonspecific and can vary depending on where the infection begins or migrates to. The bacteria can lay dormant in people as well, not causing illness until years later when a person’s health declines for other reasons. Standard diagnostic tests can also mistake the bacteria for other infections, further delaying care. Though melioidosis can be treated with antibiotics, its fatality rate can range from 10% to 50%, and it’s especially dangerous for people with underlying health problems.
Melioidosis is a serious problem in endemic areas (one estimate has found that it may kill nearly 90,000 people every year), but it’s been rare in the U.S. Until recently, nearly all cases here have been linked to travel, with the infection only being diagnosed once people returned home. But that trend has started to change as of late. Outbreaks in recent years have been tracked back to contaminated products imported from endemic areas, such as aquariums and aromatherapy sprays. And researchers have warned that there are parts of North America and the U.S. where the bacteria could easily establish a new local reservoir if it had the chance.
Once it’s established a home in the soil environment, the CDC noted, the bacteria “cannot feasibly be removed.”?
The only thing surprising about the CDC’s discovery, according to Alfredo Torres, a microbiologist and immunologist at the University of Texas Medical Branch who studies melioidosis, is that it took as long as it did to find the bacteria here.
“We and others have documented the presence of the bacteria in northern Mexico, Puerto Rico, and the Caribbean,” Torres said in an email to Gizmodo. He noted that there have been several recent cases with no travel history documented in Texas that may have been linked to a natural reservoir that was never found.
Melioidosis can theoretically be spread like an airborne disease, though this seems to require special circumstances, like heavy storms that massively kick up the surrounding soil or the use of certain medical procedures on infected patients. Otherwise, the bacteria primarily infects people through direct contact with contaminated soil or water (usually through open skin wounds), and there have been few cases of documented person-to-person transmission. That means that its potential for further spread isn’t likely to be on par with other emerging diseases like the ongoing covid-19 pandemic. But given its high lethality and difficult-to-trace nature, it has been deemed a biological threat on par with germs like anthrax or Ebola. And once it’s established a home in the soil environment, the CDC noted in its advisory, the bacteria “cannot feasibly be removed.”
B. pseudomallei doesn’t usually live on the soil surface, Torres said, so even that exposure route isn’t guaranteed for those unlucky enough to live nearby these reservoirs. But it’s possible that changes in temperature, humidity, and erosion—aided by climate change as a whole—are making the bacteria migrate to the surface and allowing it to more commonly infect humans, he added.
In sending the advisory, the CDC stated that it wanted to make sure doctors would be on the lookout for melioidosis. That’s a goal Torres firmly agrees with, but much more will have to be done to quantify its threat in North America. A 2016 paper, for instance, predicted that the soil environment in not just Mississippi, but Florida, Alabama, and other parts of the southern U.S., would be able to sustain the bacteria comfortably.
Scary as all that sounds, Torres said that confirming its presence in the U.S. should now allow scientists like him the chance to better understand and develop effective interventions against melioidosis.
“We have been doing a lot of studies in my lab and others to understand how these bacteria cause disease, but the isolates that we used are from Thailand or Australia, and some from Latin America,” he said. “Now we have a unique opportunity to study U.S. bacterial isolates and to define how infectious they are, how they cause disease in humans, and what therapeutic interventions (in addition to the vaccines that my lab have already developed) will be effective against these U.S. isolates.”
Other important questions will include figuring out the potential range and distribution of melioidosis in the U.S., as well as when and how exactly the bacteria ended up here.
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>>> Synchron says it's the first to implant a human brain-computer interface in the US
Engadget
by Jon Fingas
7-19-22
https://www.msn.com/en-us/news/technology/synchron-says-its-the-first-to-implant-a-human-brain-computer-interface-in-the-us/ar-AAZKIUC
Brain-computer interfaces have become a practical (if limited) reality in the US. Synchron says it has become the first in the country to implant a BCI in a human patient. Doctors in New York's Mount Sinai West implanted the company's Stentrode in the motor cortex of a participant in Synchron's COMMAND trial, which aims to gauge the usefulness and safety of BCIs for providing hands-free device control to people with severe paralysis. Ideally, technology like Stentrode will offer independence to people who want to email, text and otherwise handle digital tasks that others take for granted.
Synchron Stentrode brain-computer interface implant
Surgeons installed the implant using an endovascular procedure that avoids the intrusiveness of open-brain surgery by going through the jugular vein. The operation went "extremely well" and let the patient return home 48 hours later, according to Synchron. An ongoing Australian trial has also proven successful so far, with four patients still safe a year after receiving their implants.
It may take a long time before doctors can offer Synchron's BCIs to patients. The company received FDA approval for human trials in July 2021, and it's still expanding the COMMAND trial as of this writing. Still, the US procedure represents a significant step toward greater autonomy for people with paralysis. It also represents a competitive victory — Elon Musk's Neuralink has yet to receive FDA permission for its own implant.
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>>> COVID reinfection has a silver lining—one that may tame the pandemic
Fortune
BY ERIN PRATER
July 16, 2022
https://fortune.com/2022/07/16/covid-reinfection-silver-lining-t-cells-tcells-could-tame-pandemic-herd-immunity-protection/
When we talk about immune-evading COVID variants like Omicron BA.5, we’re really only talking about antibody immunity—and that’s only half of the story.
Temperatures aren’t the only thing skyrocketing right now.
It’s the summer of reinfection, with the likelihood of getting COVID yet again higher than ever, thanks to an ultra-transmissible, immune-evading subvariant. Those variants have mutated what should have been a light, breezy summer to be enjoyed into yet another heavy season to be endured—with few opportunities for reprieve, even outdoors.
The U.S. Centers for Disease Control and Prevention’s chart shows an extended wave (or wall?) of infections, with cases slowly trending upward. But wastewater data—perhaps now our best indicator of COVID in communities—belies those numbers. Nearly half of nationwide sewage testing sites reported COVID levels at 60% to 100% of their all-time high as of this week, according to CDC data.
There’s Long COVID to keep in mind too: Early studies show that repeat COVID infections—even asymptomatic and mild ones—put individuals at greater risk for the nascent condition, which can result in long-term disability and even death.
We could all use a bit of good news right now, and the good news is this: COVID variants can evade antibody immunity all they want—but they’ll still have to reckon with T cells, the oft-ignored and not-as-well-understood other half of the immune system.
While antibodies, specialized proteins produced by the immune system, search for pathogens and incapacitate or destroy them, they don’t last long—typically just a handful of months. They latch on to a specific part of a virus that’s subject to change with new variants, potentially reducing their efficacy.
T cells, a type of white blood cell produced by stem cells in the bone marrow, don’t prevent infection. But they’re capable of dramatically reducing the severity of one, rendering a potentially deadly virus all but mute in some individuals.
Because their response isn’t limited to one specific part of the virus, as is the case with antibodies, they continue to attack, even when the virus mutates and changes shape. And their protection is much more durable, known to last for years, in some cases. Experts say that widespread accumulation of T cells—from vaccine and/or infection—in the population has likely led to generally less severe outcomes for new variants sweeping the country.
“T cells are kind of a win that I don’t think are appreciated as much as they should be,” Dr. Duane Wesemann, a professor at Harvard Medical School and a principal investigator in the Division of Rheumatology, Immunology, and Allergy at Brigham and Women’s Hospital, told Fortune. They’re “not quite a silver bullet—but a composite steel bullet that's worked for us and is already in hand.”
Society is “depressed a little bit because everyone is getting infected with new variants,” Wesemann said. “But T cells are still at work, doing the good work of preventing severe disease.”
The immune system's oft-neglected other half
New COVID subvariants like BA.4 and BA.5, currently sweeping the nation, have learned to evade immunity, leading to countless reinfections—even among vaccinated people who were infected by a different subvariant just a few weeks ago.
But when we talk about immune-evading variants, we’re really only talking about antibody immunity—and that’s only half of the story. There’s a whole other side of immunity that doesn’t get much attention, in part because T cells aren’t understood as well and are more difficult to study.
T cells “have played a critical role in shielding us from the worst ravages of COVID-19,” Harvard Medical School’s Ekaterina Pesheva writes in a recent blog, adding that they are the “unsung heroes” of the pandemic.
“When antibodies fail to stop the virus from getting into our cells, T cells come to the rescue,” she writes. “If antibodies are the rampart around the castle, then T cells are the elite guards inside it that disable intruders, should they manage to sneak in.”
That means that T cells have been a critical part of our natural immune response to COVID and vaccines.
“Antibodies are what we rely on to prevent infection, but if somebody becomes infected … those T cells can attenuate the course of the disease in what can be a very dramatic way,” Dr. Bruce Walker, director of the Ragon Institute of MGH, MIT, and Harvard, a medical institute focused on eradicating disease, and co-leader of the Massachusetts Consortium on Pathogen Readiness—told Fortune. .
COVID infection leads to a “robust” T-cell response that lasts for at least 15 months, according to a study published this spring in the journal Nature Immunology. And a 2020 study published in Nature found evidence of T-cell response to another coronavirus—SARS (severe acute respiratory syndrome), an epidemic that emerged in 2002 and killed hundreds—in previously infected patients 17 years later.
Rethinking herd immunity
New subvariants like BA.4 and BA.5 are increasingly running up against a wall of T-cell based immunity in the population at large, Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, told Fortune.
Classic herd immunity—a potential end game floated by some officials during the beginning of the pandemic—isn’t possible with COVID because it continues to mutate, vaccine uptake isn’t where it needs to be, and antibody protection wanes. T cells, while less potent, offer some level of durable defense—a “herd protection” of sorts.
“Everyone focuses only on antibody-induced immunity, but for severe disease, the T-cell immunity is very, very important, and it’s not something you can just get around,” Adalja said, adding that immunity is a spectrum that ranges from merely protecting against death, hospitalization, and severe infection, to preventing infection altogether.
Hospitalizations will undoubtedly rise during the BA.4 and BA.5 wave, he said. “But will they become unmanageable? That’s become increasingly difficult for COVID to do in the U.S.”
On a similar note, Walker believes that T cells “are really what’s going to turn this pandemic into something more controllable.”
“As these new variants are arising and people are getting exposed and infected, what we’ve seen is that, in general, the virulence of the disease has not been as great,” he said earlier this month. “I think a lot of that has to do with the fact that people have generated some level of T-cell response.”
“For weeks now more transmission has been occurring, but hospitalizations haven’t gone through the roof. I think it speaks to—at least for now—some of the wind having been taken out of the sails of the pandemic.”
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>>> Novavax’s latecomer Covid-19 vaccine gets U.S. authorization.
The vaccine was authorized as a primary immunization series for adults, rather than a booster, which may limit its market at first.
Modest demand for the Novavax coronavirus vaccine in other wealthy countries leaves it unclear if the company’s prediction for the United States will hold up.
https://www.nytimes.com/2022/07/13/health/novavax-covid-vaccine-fda.html
The New York Times
By Rebecca Robbins and Carl Zimmer
July 13, 2022
The Food and Drug Administration on Wednesday authorized a Covid-19 vaccine developed by Novavax, a biotechnology company in Maryland that received significant federal funding to produce the shot. The vaccine will be a new option for Americans as vaccination rates stagnate.
After two years of development, the vaccine has finally overcome manufacturing problems to become the fourth shot to earn clearance in the United States. Advisers to the Centers for Disease Control and Prevention will meet next week and are expected to discuss who should get the Novavax vaccine.
The two-dose vaccine was authorized as a primary immunization series for adults, rather than a booster, which is likely to limit its market at first. The Biden administration said earlier this week that it would buy 3.2 million doses, enough to fully vaccinate 1.6 million people in the United States. In announcing its purchase, the government said that Novavax was expected to finish its quality testing “in the next few weeks,” a necessary step before the doses are released.
Novavax hopes that its vaccine will appeal to people who have spurned the shots from Pfizer-BioNTech and Moderna, which use messenger RNA technology. About 22 percent of people in the United States have not received a single Covid vaccine dose.
Novavax’s vaccine, given in doses spread three weeks apart, works differently from mRNA vaccines. It provokes an immune response with nanoparticles made up of proteins from the surface of the coronavirus that causes Covid-19. Similar protein-based vaccines have been widely used around the world for decades.
But modest demand for the Novavax shot in other wealthy countries leaves it unclear if the company’s prediction for the United States will hold up. In Europe, only 12.6 million Novavax doses were distributed between December, when the vaccine was authorized there, and June 30. In contrast, more than a billion doses of Pfizer-BioNTech and Moderna vaccines have been distributed in Europe.
A Morning Consult poll released earlier this month suggests that Novavax may meet a similar lack of enthusiasm in the United States. Only 10 percent of unvaccinated people contacted for the poll said they would definitely or probably get a protein-based vaccine.
The authorization comes with a warning that Novavax’s vaccine is linked to an elevated but small risk of forms of heart inflammation known as myocarditis and pericarditis. In their review of Novavax’s data, F.D.A. scientists identified six cases of the side effect in about 40,000 trial volunteers.
The mRNA vaccines from Moderna and Pfizer-BioNTech are also linked to an elevated risk of these conditions, but that link did not emerge until after they were put into large-scale use. A warning about the risk was also added to their packaging.
Before the pandemic, Novavax was a little-known biotechnology company with several vaccines in the research pipeline, but no approved products. It rose to prominence when Operation Warp Speed, the federal government’s 2020 campaign to develop coronavirus vaccines, picked it out for support. The program initially agreed to pay up to $1.6 billion to fund the development of the vaccine and to purchase up to 100 million doses of the shot.
But a series of manufacturing delays meant that the shot was not available for the initial surge of vaccinations in the United States in early 2021.
The manufacturing woes have continued to dog the company. Even after an F.D.A. advisory committee recommended authorizing the vaccine in early June, the agency took weeks to give it the green light, because it needed more time to sign off on Novavax’s manufacturing process. The Serum Institute of India, the world’s largest vaccine producer, is manufacturing Novavax’s vaccine.
In a number of clinical trials, Novavax found that its vaccine was highly protective against symptomatic infection. But the original formulation is probably not as effective against the Omicron variant, which emerged in November and has evaded some of the protection afforded by authorized vaccines from other companies.
Novavax is developing new versions of its vaccine that target Omicron and its highly contagious subvariants. Preliminary data from laboratory and animal studies indicate that a booster shot aimed at a previous Omicron subvariant, BA.1, generates strong immune responses to the virus. The company says it expects to have results from a clinical trial of that shot in September, with doses ready in the last three months of this year.
The company says it plans to accelerate its research on shots specifically tailored for two newer versions of Omicron, known as BA.4 and BA.5.
Trials have also shown that Novavax’s shot works well as a booster, and the company is expected to seek authorization for boosters soon. The company may then be able to attract vaccinated people who want to switch to a new option to protect against new variants.
John Moore, a virologist at Weill Cornell, said he considered Novavax an excellent vaccine but was not yet convinced that an Omicron-based booster would provide much extra protection compared with the original version. “There’s too little information,” he said.
Dr. Moore speculated that some people might switch to Novavax for a booster this fall because it produced relatively few cases of aches, fatigue and other passing side effects in clinical trials. That was his experience as a volunteer in one of Novavax’s trials. “The only way I could tell the next day which arm I had the needle in was the Band-Aid,” he said.
If Novavax is authorized for a booster, Dr. Moore would happily return for another shot, he said: “At some point in the fall, I’ll have another dose, and it would be Novavax.”
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>>> All disease begins in the (leaky) gut: role of zonulin-mediated gut permeability in the pathogenesis of some chronic inflammatory diseases
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6996528/
Version 1. F1000Res. 2020; 9: F1000 Faculty Rev-69. Published online 2020 Jan 31. doi: 10.12688/f1000research.20510.1
PMCID: PMC6996528PMID: 32051759
Alessio Fasano
1Mucosal Immunology and Biology Research Center, Center for Celiac Research and Treatment and Division of Pediatric Gastroenterology and Nutrition, Massachusetts General Hospital for Children, Boston, Massachusetts, USA
2European Biomedical Research Institute of Salerno, Salerno, Italy
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Long Covid - >>> Innovative lung-imaging technique shows cause of long COVID symptoms
Medical Xpress
by Crystal Mackay
University of Western Ontario
https://medicalxpress.com/news/2022-06-lung-imaging-technique-covid-symptoms.html
By having study participants inhale polarized xenon gas while inside the MRI, the researchers see in real-time the function of the 300-500 million tiny alveolar sacs, which are responsible for delivering oxygen to the blood.
Many who experience what is now called "long COVID" report feeling brain fog, breathless, fatigued and limited in doing everyday things, often lasting weeks and months post-infection. Using functional MRI with inhaled xenon gas, researchers have now identified for the first time that these debilitating symptoms are related to microscopic abnormalities that affect how oxygen is exchanged from the lungs to the red blood cells.
The LIVECOVIDFREE study, based at five centers across Ontario, and led by Western University professor Grace Parraga, is the largest MRI study of patients with long COVID. The research, published in Radiology, is the first to show a potential cause of these long COVID symptoms. By understanding the cause, team members responsible for patient care have been able to target treatment for these patients.
"I think it is always a conundrum when someone has symptoms, but you can't identify the problem. Because if you can't identify the problem, you can't identify solutions," said Parraga, Tier 1 Canada Research Chair in Lung Imaging to Transform Outcomes at Western's Schulich School of Medicine & Dentistry.
By having study participants inhale polarized xenon gas while inside the MRI, the researchers see in real-time the function of the 300-500 million tiny alveolar sacs, which are about 1/5 of a mm in diameter and responsible for delivering oxygen to the blood.
"With our MRI technique, we can watch in real time the air moving through the alveolar membrane and through to the blood cells; and we can actually see the function of the tiny alveolar sacs in the lungs," said Parraga. "What we saw on the MRI was that the transition of the oxygen into the red blood cells was depressed in these symptomatic patients who had had COVID-19, compared to healthy volunteers."
Further CT scans pointed to "abnormal trimming" of the vascular tree, indicating an impact on the tiny blood vessels that deliver red blood cells to the alveoli to be oxygenated.
There also doesn't appear to be any difference in severity of this abnormality between patients who had been hospitalized with COVID-19, and those who recovered without hospitalization, the study said. This is an important finding as the latest wave of COVID-19 infection has affected large numbers of people who did not need hospital-based care.
"For those who are symptomatic post-COVID, even if they hadn't had a severe enough infection to be hospitalized, we are seeing this abnormality in the exchange of oxygen across the alveolar membrane into the red blood cells," said Parraga.
The researchers recruited patients with suspected long COVID from two hospitals in London, Ontario: London Health Sciences Centre's (LHSC) Urgent COVID-19 Care Clinic (LUC3), and St. Joseph's Health Care London's post-acute COVID-19 program. Participants were those with persistent shortness of breath more than six-weeks post-infection. Some study participants were still symptomatic after 35 weeks.
Study co-author Dr. Michael Nicholson is a respirologist with St. Joseph's post-acute COVID-19 program, former member of the LUC3 clinical team at LHSC, and an associate scientist at Lawson Health Research Institute. He said patients who were describing these symptoms were also showing normal results on clinical breathing tests.
These scans show what a healthy lung looks like (left) and lungs of patients after having COVID-19 (last three). The images also show where air flows in the lungs.
"We were looking for further modalities to look at their lung function that were not found through traditional clinical testing," said Nicholson. "The findings allowed us to show that there was a physiological impact on their lungs that correlated with their symptoms."
Study participant Alex Kopacz described his experience with COVID-19 as "harrowing." He was admitted to LHSC's University Hospital with the virus in 2021. A young, fit Canadian bobsledder and Olympic gold medalist, he never imagined that he would still be struggling to breathe months after infection.
"I was on oxygen for almost two months after COVID, and it took me almost three months to get to a place where I could go for a walk without gasping for air," said Kopacz. "The take-home message for me is that we have to remember that this virus can have very serious long-term consequences, which are not trivial. In my case, prior to getting sick, I didn't think it would really affect me."
A one-year follow-up is now underway to better understand these results longitudinally. The study was done in collaboration with researchers at LHSC, St. Joseph's, Lakehead University, McMaster University, Toronto Metropolitan University and Sick Kids Hospital in Toronto.
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>>> Mycotoxins – Introduction and Remediation
GreenWorks
https://greenworksllc.com/learn/mycotoxins-introduction-and-remediation/
Mycotoxins - introduction and remediation
Most of us think we are pretty familiar with “mold” and the allergy-related health effects they can cause. What many folks don’t realize is that some molds produce toxic compounds known as “mycotoxins” that are some of the most toxic substances in existence. The type of mold dictates the type of mycotoxin you are dealing with where each has their own set of special properties.
Mycotoxin Action
Mycotoxins are nearly all cytotoxic, disrupting cellular membranes and interfering with vital cellular processes (protein, RNA & DNA synthesis). Of course, they are also toxic to the cells of higher plants and animals, including humans. Higher organisms are not specifically targeted by mycotoxins but seem to be caught in the crossfire of the biochemical warfare among molds and bacteria vying for the same environment.
Mycotoxin Potency & Duration
Mycotoxins vary in specificity and potency by species/mold strain and the type of substrate they feed on. What is still unknown are the effects of different mycotoxins in the same environment (the cocktail effect). Most mycotoxins do break down and lose their toxicity over time. But some take years like the Trichothecene Group (produced by Stachybotrys molds) is very stable and the most resilient of the mycotoxins.
The United States has not yet set maximum levels for mycotoxins in the air of buildings. Also, the health issues that mold and toxic molds can cause are not yet officially recognized medically and many doctors are unaware of the symptoms mold can cause. But the Environmental Protection Agency (EPA) has acknowledged that mold growing in homes is harmful to humans and that it should be removed.
Mycotoxins aren’t actually alive like mold spores. When “killing mycotoxins” it really means breaking them down so they are no longer dangerous to humans. Mold Remediation firms should supplement industry standards with the following:
Sodium Hypochlorite has been found to kill trichothecene and other mycotoxins.
Extreme heat (fire at 500°F for half-hour) can destroy trichothecene mycotoxins.
Ozone can kill most mycotoxins, but the level needed is not safe for humans.
HEPA air filters need to be supplemented with activated carbon filters.
Ultraviolet light or freezing temperatures have little effect on trichothecene.
Mycotoxins left in a dry environment remain potent for years.
Most mycotoxins usually end up embedded in the carpet. Walking on carpet stirs up the mycotoxin particles along with other spores and allergens. HEPA Vacuuming will not remove all the mycotoxins embedded in the carpet. Central vacuuming systems may help to remove mycotoxins if the air is exhausted outside. There is no cost-effective way to remove mycotoxins from the carpet. The best option is to remove and replace the carpet.
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>>> Dangerous viruses 'hitchhike' on microplastics to survive in freshwater
You could swallow them while swimming.
Interesting Engineering
By Derya Ozdemir
Jun 27, 2022
https://interestingengineering.com/viruses-hitchhike-on-microplastics-freshwater
Dangerous viruses 'hitchhike' on microplastics to survive in freshwater
Every year, between 4.8 and 12.7 million tonnes of plastic enter the ocean. Larger pieces of plastic waste get weathered and degrade, breaking down into smaller and smaller pieces, eventually reducing to microplastic particles.
These microplastics then end up in our food, drinking water, and even the air we breathe. And, in addition to damaging human cells, it turns out that microplastics serve as a haven for dangerous viruses that can cause vomiting and diarrhea.
A team of researchers from the Stirling University has proven for the first time that viruses can survive and remain contagious by attaching themselves to plastics in water, according to a study published in the journal Environmental Pollution.
This finding raises questions regarding the impact on human health and potential health risks, as microplastics could easily be swallowed by someone swimming.
‘Hitch-hiking’ viruses
The latest study is the first of its kind to look into the issue of microplastics and viruses utilizing water taken from the natural environment. Previous studies concentrated solely on the transmission of such viruses in sterile hospital settings.
In the study, the Stirling University researchers utilized two species of model viruses, rotavirus (RV) SA11—a human gastrointestinal virus—and the bacteriophage virus Phi6, and examined how they attach themselves to microplastic pellets in three different types of water, filtered surface water, unfiltered surface water, and surface water with added nutrients.
The researchers found that viruses that were hitchhiking on the microplastic pellets were more stable compared to those residing in the water. For example, the rotavirus, which causes diarrhoea and an upset stomach, was found to survive for up to three days in lake water by attaching itself to the surfaces of microplastics. By adhering to the microplastic surface, virus particles were shielded from elements such as UV light, which would typically kill them.
A bigger evil than previously thought
“Even if a wastewater treatment plant is doing everything it can to clean sewage waste, the water discharged still has microplastics in it, which are then transported down the river, into the estuary and end up on the beach. We weren’t sure how well viruses could survive by ‘hitch-hiking’ on plastic in the environment, but they do survive, and they do remain infectious," Richard Quilliam, lead researcher on the project at the U.K.'s Stirling University, said in a press release.
“Microplastics are so small that they could potentially be ingested by someone swimming, and sometimes they wash up on the beach as lentil-sized, brightly coloured pellets called nurdles that children might pick up and put in their mouths. It doesn’t take many virus particles to make you sick. And if the viruses then release themselves from the plastic into the water or the sand, their persistence in the environment is increased."
This discovery could have far-reaching repercussions for human health around the planet, as dangerous viruses and bacteria might migrate across oceans without being carried by humans. To uncover more about the unknown dangers of microplastic pollution merging with the threat of viruses, the researchers will look at how long they can remain infectious next.
“This research is very much a proof-of-concept for conducting more research into how long pathogens can survive by binding to microplastics, as we only tested for three days, and what happens to them next," Quilliam said.
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gfp927z; Study: Medical Marijuana Reduces Pain, Depression, Increases Life Quality in
Cancer Patients
https://www.newsmax.com/health/health-news/cancer-marijuana-medical-pain/2022/05/24/id/1071322
MediPharm Labs Continues to Lead with Innovation - Launches CBG and Water-Soluble Products
T.LABS |
View original content to download multimedia:
https://www.prnewswire.com/news-releases/medipharm-labs-continues-to-lead-with-innovation--launches-cbg-and-water-soluble-products-301517368.html
David Pidduck is the new CEO of MediPharm Labs
https://seekingalpha.com/news/3824667-david-pidduck-is-the-new-ceo-of-medipharm-labs?source=copyToPasteboard
Wow, is this c-suite change another signal of failure?
HAPPY BIRTHDAY PRESIDENT DONALD J TRUMP FROM CHARLIE WARD & ALL OF THE TRUTH COMMUNITY
WATCH
https://www.bitchute.com/video/VztdCmvZLgU/
CT Thanks; How many more good music artists has been hit like Justin Bieber???
DR. JUDY MIKOVITS PhD - THE PLAN TO INJECT HUMANITY WITH CANCER VIRUSES!
WATCH
https://www.bitchute.com/video/QMT4KXNWow9c/
Justin Bieber recently came out to tell fans he’s come down with Ramsay Hunt
Syndrome, which caused partial paralysis in his face — it turns out RHS is a
known vaccine side effect.
https://thecountersignal.com/justin-bieber-paralysis-is-a-known-vaccine-side-effect/
STATEMENT BY PRESIDENT DONALD J. TRUMP
Quote:
could not copy the entire story-- here is the link
:
https://cdn.nucleusfiles.com/e7/e746fae9-7a5f-462d-a0dd-dd9a11895451/statement-by-president-donald-j.-trump.pdf?
M_P; $500 TRILLION LAWSUIT AGAINST THE FEDERAL GOVT AND OVER 140
MONOPOLISTS (REMOVED BY YOUTUBE IN 5HRS)
WATCH
https://www.bitchute.com/video/QFcfDjifRl6u/
Leaked medicare data shows a 50% rise in all cause mortality of the elderly for the first time ever.
https://www.bitchute.com/video/DdxZLSGHmKLB/
They are right. Covid kills...the Covid vaccine is killing the elderly by the thousands. Source: Fat News.
CLIF HIGH - THE JABBED ARE ABOUT TO GET A RUDE AWAKENING
https://www.bitchute.com/video/bBcmJoO3BRdh/
"Organoids "Jab victim discharging biological creatures woman reports horror after Moderna shot
https://www.bitchute.com/video/BCrvrznQFaME/
SUBMIT TO THE BIOWEAPON OR REMAIN OUR HOSTAGE FOREVER --
BRENT JOHNSON - NWO Totalitarian Dictators Blackmail Anti-Human Genocide
killer agenda super communistic evil khazarian
WATCH
https://www.bitchute.com/video/l881ILlbk6UJ/
BREAKING!!! COVID VACCINE CLAIMS OVERWHELM COURTS
WATCH
https://www.bitchute.com/video/fxqw0Y7twx3o/
MASS DEPOPULATION ACCORDING TO PFIZER! - DOCUMENT LEAK
PROVES VACCINE IS CAUSING DIE OFF!
WATCH
https://www.bitchute.com/video/Ga7fvxiL1jFa/
Zardiw; Sarah Palin Pulls Ahead In Race For Alaska Representative
Photo of Carmine Sabia Carmine SabiaJune 12, 2022
https://conservativebrief.com/sarah-p-63700/
CT; M_P; VACCINES ARE MAKING PEOPLE NEUROLOGICALLY NUMB
WATCH
https://www.bitchute.com/video/aT3AxrAOGWeT/
US Is "Beyond Bankrupt" - Kim Dotcom Fears "Controlled Demolition" Enabling A "New Dystopian Future"
Tyler Durden's Photo
BY TYLER DURDEN
SATURDAY, JUN 11, 2022 - 04:44 AM
https://www.zerohedge.com/markets/its-worse-many-can-imagine-kim-dotcom-sees-controlled-demolition-enabling-new-dystopian
https://rumble.com/v1896jo-real-love.html
https://www.whatdoesitmean.com/index.htm
God Bless.
Ps.
Bill Holter – A Parallel Economy Is Emerging Which Wreak Havoc On The [CB]
System - X22 Report - VIDEO
https://x22report.com/aiovg_videos/bill-holter-a-parallel-economy-is-emerging-which-wreak-havoc-on-the-cb-system/
Jan. 6 Was ‘An Inside Job to Entrap People Who Attended Trump’s Speech’:
Investigative Journalist.. :+O
https://www.theepochtimes.com/jan-6-was-an-inside-job-to-entrap-people-who-attended-trumps-speech-investigative-journalist_4524391.html
>>> A Cancer Trial's Unexpected Result: Remission in Every Patient
The New York Times
by Gina Kolata
June 6, 2022
https://news.yahoo.com/cancer-trials-unexpected-result-remission-120646950.html
It was a small trial, just 18 rectal cancer patients, every one of whom took the same drug.
But the results were astonishing. The cancer vanished in every single patient, undetectable by physical exam; endoscopy; positron emission tomography, or PET scans; or MRI scans.
Dr. Luis A. Diaz Jr. of Memorial Sloan Kettering Cancer Center, an author of a paper published Sunday in the New England Journal of Medicine describing the results, which were sponsored by drug company GlaxoSmithKline, said he knew of no other study in which a treatment completely obliterated a cancer in every patient.
“I believe this is the first time this has happened in the history of cancer,” Diaz said.
Dr. Alan P. Venook, a colorectal cancer specialist at the University of California, San Francisco, who was not involved with the study, said he also thought this was a first.
A complete remission in every single patient is “unheard-of,” he said.
These rectal cancer patients had faced grueling treatments — chemotherapy, radiation and, most likely, life-altering surgery that could result in bowel, urinary and sexual dysfunction. Some would need colostomy bags.
They entered the study thinking that, when it was over, they would have to undergo those procedures because no one really expected their tumors to disappear.
But they got a surprise: No further treatment was necessary.
“There were a lot of happy tears,” said Dr. Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center and a co-author of the paper, which was presented Sunday at the annual meeting of the American Society of Clinical Oncology.
Another surprise, Venook added, was that none of the patients had clinically significant complications.
On average, 1 in 5 patients have some sort of adverse reaction to drugs like the one the patients took, dostarlimab, known as checkpoint inhibitors. The medication was given every three weeks for six months and cost about $11,000 per dose. It unmasks cancer cells, allowing the immune system to identify and destroy them.
While most adverse reactions are easily managed, as many as 3% to 5% of patients who take checkpoint inhibitors have more severe complications that, in some cases, result in muscle weakness and difficulty swallowing and chewing.
The absence of significant side effects, Venook said, means that “either they did not treat enough patients or, somehow, these cancers are just plain different.”
In an editorial accompanying the paper, Dr. Hanna K. Sanoff of the University of North Carolina’s Lineberger Comprehensive Cancer Center, who was not involved in the study, called it “small but compelling.” She added, though, that it is not clear if the patients are cured.
“Very little is known about the duration of time needed to find out whether a clinical complete response to dostarlimab equates to cure,” Sanoff said in the editorial.
Dr. Kimmie Ng, a colorectal cancer expert at Harvard Medical School, said that while the results were “remarkable” and “unprecedented,” they would need to be replicated.
The inspiration for the rectal cancer study came from a clinical trial Diaz led in 2017 that Merck, the drugmaker, funded. It involved 86 people with metastatic cancer that originated in various parts of their bodies. But the cancers all shared a gene mutation that prevented cells from repairing damage to DNA. These mutations occur in 4% of all cancer patients.
Patients in that trial took a Merck checkpoint inhibitor, pembrolizumab, for up to two years. Tumors shrank or stabilized in about one-third to one-half of the patients, and they lived longer. Tumors vanished in 10% of the trial’s participants.
That led Cercek and Diaz to ask: What would happen if the drug were used much earlier in the course of disease, before the cancer had a chance to spread?
They settled on a study of patients with locally advanced rectal cancer — tumors that had spread in the rectum and sometimes to the lymph nodes but not to other organs. Cercek had noticed that chemotherapy was not helping a portion of patients who had the same mutations that affected the patients in the 2017 trial. Instead of shrinking during treatment, their rectal tumors grew.
Perhaps, Cercek and Diaz reasoned, immunotherapy with a checkpoint inhibitor would allow such patients to avoid chemotherapy, radiation and surgery.
Diaz began asking companies that made checkpoint inhibitors if they would sponsor a small trial. They turned him down, saying the trial was too risky. He and Cercek wanted to give the drug to patients who could be cured with standard treatments. What the researchers were proposing might end up allowing the cancers to grow beyond the point at which they could be cured.
“It is very hard to alter the standard of care,” Diaz said. “The whole standard-of-care machinery wants to do the surgery.”
Finally, a small biotechnology firm, Tesaro, agreed to sponsor the study. Tesaro was bought by GlaxoSmithKline, and Diaz said he had to remind the larger company that they were doing the study — company executives had all but forgotten about the small trial.
Their first patient was Sascha Roth, then 38. She first noticed some rectal bleeding in 2019 but otherwise felt fine — she is a runner and helps manage a family furniture store in Bethesda, Maryland.
During a sigmoidoscopy, she recalled, her gastroenterologist said, “Oh no. I was not expecting this!”
The next day, the doctor called Roth. He had had the tumor biopsied. “It’s definitely cancer,” he told her.
“I completely melted down,” she said.
Soon, she was scheduled to start chemotherapy at Georgetown University, but a friend had insisted she first see Dr. Philip Paty at Memorial Sloan Kettering. Paty told her he was almost certain her cancer included the mutation that made it unlikely to respond well to chemotherapy. It turned out, though, that Roth was eligible to enter the clinical trial. If she had started chemotherapy, she would not have been.
Not expecting a complete response to dostarlimab, Roth had planned to move to New York for radiation, chemotherapy and possibly surgery after the trial ended. To preserve her fertility after the expected radiation treatment, she had her ovaries removed and put back under her ribs.
After the trial, Cercek gave her the news.
“We looked at your scans,” she said. “There is absolutely no cancer.” She did not need any further treatment.
“I told my family,” Roth said. “They didn’t believe me.”
But two years later, she still does not have a trace of cancer.
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>>> mRNA creators studying vaccines' myocarditis risk
Yahoo Finance
by Anjalee Khemlani
June 7, 2022
https://finance.yahoo.com/news/m-rna-creators-studying-vaccines-heart-inflammation-risk-185318811.html
The co-creators of the mRNA technology used in both Pfizer (PFE)/BioNTech's (BNTX) and Moderna's (MRNA) COVID-19 vaccines are looking into the causes of a low risk of heart inflammation, especially in younger males.
Dr. Katalin Karikó and Dr. Drew Weissman spoke with Yahoo Finance Tuesday, a day they were being awarded for their research from Northwell Health's Feinstein Institutes for Research.
Karikó, a biochemist at University of Pennsylvania and senior vice president at BioNTech, began working on the RNA technology 35 years ago, and struggled to garner academic support. Weissman, a physician and scientist at University of Pennsylvania, joined the research 10 years after she began, and the two worked tirelessly to get mRNA to the point it was — primed and ready for use — at the start of the pandemic.
"Back then, we never imagined that RNA would be used to stop a pandemic, but we knew it had incredible potential," Weissman said, adding that the experience has been a whirlwind.
Karikó said she is amused that the general population can identify the brand of vaccine they are receiving.
"No other medicine people talk about...who made it," she said, but added that because the new technology came to the fore amid a pandemic, there does remain some hesitancy.
"Maybe prior to that, we should have done more work and educated the public so maybe [there would be] less resistance ... against the RNA technology," Karikó said.
To that end, some concerns have arisen from real-world data showing a causal link between the vaccines and heart inflammations, known as myocarditis and pericarditis. Weismann said he and a collaborator will be publishing new findings soon.
"What people have to understand is....if you look at COVID-19, the myocarditis that the disease gives you occurs at about 30 times higher frequency. So, yes, it's true that the vaccine has a rare adverse event of myocarditis, and we and others are trying to understand how it occurs and how to avoid it," Weissman said.
"We're actually working on a paper right now that identifies the mechanism," he added, but declined to drop any hints.
Karikó noted that the risk is not just from the mRNA, but also in Novavax's (NVAX) recombinant protein vaccine as well. (The FDA's advisory committee is meeting Tuesday to discuss that and other data related to the company's emergency use authorization filing.)
A discussion on the topic arose during the FDA's advisory committee meeting Tuesday.
One member of the committee, Dr. Cody Meissner, a vaccine expert and chief of pediatric infectious diseases at Tufts Children's Hospital, emphasized how little is currently known about the link to myocarditis.
"There's been such variation in reports of the rates of myocarditis following administration of these vaccines that I think it's very hard to say that it occurs more frequently...with one vaccine platform than with another," he said.
Dr. Paul Offit, a vaccine expert and director of the Vaccine Education Center at the Children's Hospital of Pennsylvania, said there is an urgent need to understand that cause as the virus is going to be with us for generations.
"So that we can use that knowledge to make safer vaccines for a disease that is going to be with us for decades if not longer," he said.
But, he also noted that with a low risk of adverse events for several vaccines, more understanding is needed. Still, no vaccine will be 100% risk free.
"Everything in medicine is about taking the choice that puts you at lowest risk. Whether that's the surgery you're about to get or medicine you're about to take. There are no risk-free choices," Offit told Yahoo Finance.
Moderna's chief medical officer Dr. Paul Burton, in a separate interview Tuesday with Yahoo Finance, said the risk of myocarditis could have to do with an interaction with the spike protein — which plays a role in the basis of all Covid vaccines — and heart muscle cells.
"We know so much more about myocarditis today than we did a year ago. I do believe that it is the spike protein....that either causes a little bit of direct damage to the heart, or antibodies that are produced that react with the heart cells," Burton said.
Global potential
As global public health experts warn the coronavirus outbreak won't be the last pandemic, lower- and middle-income countries have begun to lay the infrastructure to incorporate mRNA technology for future outbreaks.
That can be seen in recent announcements to open plants in sub-Saharan Africa from BioNTech, Moderna and the Serum Institute of India. Weissman has been working with the World Health Organization as it set up an mRNA hub in South Africa, and worked with Thailand in the spring of 2020 to set up a GMP (good manufacturing practices) manufacturing site.
"I'm continuing to do that worldwide, working with countries, governments, organizations, and to give them the technology to make RNA therapeutics locally. And, to me, that's probably one of the most important things that I do," Weissman said.
When the vaccines were first authorized in the U.S., they faced cold chain barriers for some regions of the world that couldn't handle the ultra-cold storage temperatures required. But since the first batch, that has been addressed.
"The cold chain was purely a speed issue," Weissman said.
Companies "spend a lot of time on how to stabilize, how to ship, how to produce at the highest temperatures possible. For the COVID vaccine, there was such a rush to get them out that they didn't do that," he added.
Karikó noted that the tradeoff to increasing the temperature for storage is a shorter lifespan, compared to when it is kept at ultra-low temperatures.
In addition to addressing the cold chain barrier, raw materials and supplies needed to make mRNA vaccines are now being abundantly produced, compared to the strict supply that existed at the start of the pandemic.
"We never imagined that we would want to make 5 billion or more doses of RNA vaccine," Weissman said.
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>>> 1 in 5 adult COVID survivors experience long COVID symptoms, CDC says
Fortune
BY ERIN PRATER
May 25, 2022
https://fortune.com/2022/05/25/1-in-5-adult-covid-survivors-experience-long-covid-symptoms-cdc-says/
One in five adults experienced at least one potentially attributable medical condition in the weeks and months following infection, according to a study released Tuesday by the U.S. Centers for Disease Control and Prevention.
The study examined the de-identified electronic health records of nearly 2 million patients, matching those with a documented COVID diagnosis to similar patients without documented infection. The health records examined were from March 2020 through November 2021.
The study looked at both sets of patients for nearly 30 conditions that have previously been associated with post-COVID illness, also known as long COVID. Those conditions included heart disease, kidney failure, anxiety, asthma, bleeding disorders, gastrointestinal disorders, fatigue, heart failure, pain, heart attack, dementia, sleeping disorders, and diabetes. Those who had a history of such conditions before the study were excluded. Patients were followed until their first qualifying medical incident or through Oct. 31 of last year, whichever came first.
The study found that roughly one in five COVID survivors ages 18–64, and one in four ages 65 or older, experienced a medical event or diagnosis that could be attributable to COVID in the weeks and months after infection.
Among adults of all ages, the most commonly observed new complaints were respiratory symptoms and musculoskeletal pain. Seniors who survived COVID were at increased risk for neurologic conditions and many mental health conditions when compared to peers who didn’t have COVID. Post-COVID medical issues could hasten seniors’ entry into care centers and nursing homes, the authors stated.
The findings are “consistent with those from several large studies that indicated that post-COVID incident conditions occur in 20%–30% of patients,” the authors wrote. They noted that COVID can have long-term effects on individuals’ health care needs and economic well-being, as some are too sick to return to work. They also noted the potential impact on the health care system, which could find itself under strain after “heavy” COVID surges.
The study didn’t take into account vaccination status, and may not be reflective of post-COVID complication waves from other variants like Omicron, which may differ, the authors wrote.
The authors call for the use of COVID-19 prevention strategies and the monitoring of all COVID survivors, especially seniors, for post-COVID medical conditions.
A new condition, difficult to define
Long COVID is poorly understood, and definitions vary.
The World Health Organization defines long COVID as a condition that occurs in someone who had COVID, with symptoms that cannot be explained by another diagnosis, that last for two months or more. The symptoms can persist following the initial onset, or come and go over time, the organization says, adding that a diagnosis of long COVID usually wouldn't be made until three months after acute illness.
The Mayo Clinic defines long COVID as a set of symptoms stemming from COVID that persist for more than four weeks after diagnosis.
In reality, long COVID is likely an umbrella term for a combination of issues and conditions: people who have long-term COVID infections who are able to continue to spread the disease; people whose COVID aftereffects clear up after a few weeks; and people with long COVID itself who aren’t infectious but experience all kinds of symptoms for much longer.
What’s more, COVID patients whose disease was severe enough to require ICU admission may suffer post-ICU complications like muscle weakness, shortness of breath, cognitive issues, anxiety, and depression—symptoms that look a lot like Long COVID, but are not. Those issues might occur due to extended periods of immobility and ventilator use, and other traumatic medical events.
Long COVID may already affect between 7 million and 23 million Americans who previously had the virus, or up to 7% of the U.S. population, according to the U.S. Government Accountability Office. It could potentially impact over a billion worldwide in just a few years, says Arijit Chakravarty, a COVID researcher and CEO of Fractal Therapeutics, a drug development firm. Experts say that it’s quickly growing into a major public health concern already overwhelming primary-care physicians.
It seems like most any ailment—from ear numbness, a sensation of “brain on fire,” and hallucinations—could be a symptom of long COVID, according to a landmark July study published in British medical journal The Lancet.
The study identified more than 200 potential long COVID symptoms in 10 organ systems, with 66 symptoms typically lasting more than seven months. Researchers surveyed nearly 4,000 sufferers from nearly 60 countries with confirmed or suspected COVID, with illness of a month or longer.
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A Board to discuss Healthcare stock ideas -
Healthcare -
Abbott Labs (ABT) - Diverse healthcare products (209 Bil) --------------------------------------- 1.9% (Healthcare)
AbbVie (ABBV) - Research unit from Abbott Labs (286 Bil) --------------------------------------- 3.8% (Healthcare)
Amgen (AMGN) - Biopharma (166 Bil) ------------------------------------------------------------------ 2.9% (Healthcare)
Cencora (COR) - Pharmaceuticals distribution (Amerisource Bergen) (44 Bil) --------------- 0.9% (Healthcare)
Chemed (CHE) - Hospice and palliative health care1 svs, Roto Rooter (9 Bil) --------------- 0.3% (Healthcare)
Danaher (DHR) - Diverse healthcare related, other (172 Bil) ------------------------------------- 0.4% (Healthcare)
Elevance Health (ELV) - Health benefits company (formerly Anthem) (120 Bil) -------------- 1.3% (Healthcare)
Eli Lilly (LLY) - Pharmaceuticals (607 Bil) -------------------------------------------------------------- 0.8% (Healthcare)
Ensign Group (ENSG) - Skilled nursing + rehabilitative svcs (5 Bil) ---------------------------- 0.3% (Healthcare)
Icon PLC (ICLR) - CRO development svcs to biopharma ind (Ireland) (23 Bil) --------------- 0% (Healthcare)
iShares US Medical Devices ETF (IHI) (0.42%) ----------------------------------------------------- 0.2% (Healthcare)
Johnson & Johnson (JNJ) - Diverse healthcare products (389 Bil) (Berkshire) ----------- 2.9% (Healthcare)
McKesson (MCK) - Pharma distribution, med supplies, IT svcs (69 Bil) (Berkshire) ------- 0.5% (Healthcare)
Medpace Holdings (MEDP) - CRO (10 Bil) ------------------------------------------------------------- 0% (Healthcare)
Merck (MRK) - Pharmaceuticals (305 Bil) -------------------------------------------------------------- 2.6% (Healthcare)
Molina Healthcare (MOH) - Managed healthcare services, Medicare, Medicaid (21 Bil) --- 0% (Healthcare)
Novartis (NVS) - Pharmaceuticals (209 Bil) ------------------------------------------------------------ 3.7% (Healthcare)
Novo Nordisk (NVO) - Pharmaceuticals (482 Bil) (Denmark) ------------------------------------ 1.0% (Healthcare)
Steris (STE) - Infection prevention, heathcare products + svcs (Ireland) (23 Bil) ----------- 0.9% (Healthcare)
Stryker (SYK) - Diverse medical, surgical devices, implants (118 Bil) -------------------------- 1.0% (Healthcare)
UFP Technologies (UFPT) - Diverse packaging, component products (1.7 Bil) --------------- 0% (Healthcare)
UnitedHealth Group (UNH) - Health benefits company (440 Bil) -------------------------------- 1.3% (Healthcare)
Zoetis (ZTS) Veterinary drugs and vaccines (80 Bil) ------------------------------------------------- 0.9% (Healthcare)
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Name | Symbol | % Assets |
---|---|---|
Johnson & Johnson | JNJ | 8.47% |
UnitedHealth Group Inc | UNH | 5.80% |
Merck & Co Inc | MRK | 5.39% |
Pfizer Inc | PFE | 5.06% |
Abbott Laboratories | ABT | 3.56% |
Medtronic PLC | MDT | 3.52% |
Amgen Inc | AMGN | 3.14% |
Thermo Fisher Scientific Inc | TMO | 2.92% |
AbbVie Inc | ABBV | 2.84% |
Eli Lilly and Co | LLY | 2.40% |
Name | Symbol | % Assets |
---|---|---|
Abbott Laboratories | ABT | 12.57% |
Thermo Fisher Scientific Inc | TMO | 12.41% |
Danaher Corp | DHR | 10.58% |
Medtronic PLC | MDT | 10.33% |
Intuitive Surgical Inc | ISRG | 4.71% |
Edwards Lifesciences Corp | EW | 4.47% |
Stryker Corp | SYK | 4.27% |
Becton, Dickinson and Co | BDX | 4.19% |
Boston Scientific Corp | BSX | 4.15% |
IDEXX Laboratories Inc | IDXX | 3.71% |
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HEALTHCARE -
Abbott Labs (ABT) - Diverse healthcare products (66 Bil) ------------------------------------- 2.2%
Acadia Healthcare (ACHC) - Behavioral healthcare services (5 Bil) ------------------------ 0%
Cerner (CERN) - Health care information technology (25 Bil) --------------------------------- 0%
Chemed (CHE) - Hospice and palliative health care svs, Roto Rooter (1.7 Bil) ---------- 0.9%
Danaher (DHR) - Diverse healthcare related, other (80 Bil) ---------------------------------- 0.52%
DaVita (DVA) - Kidney dialysis services (18 Bil) --------------------------------------------------- 0%
Healthcare Services (HCSG) - Laundry + maint to h.care facil, dietary svcs (1.9 Bil) -- 2.3%
Johnson & Johnson (JNJ) - Diverse healthcare related products (285 Bil) --------------- 2.8%
Mednax (MD) - Neonatal and pediatric medicine, anesthesiology (8 Bil) ------------------- 0%
Reckitt Benckiser (RBGLY) - Healthcare, hygiene, home care products, UK (62 Bil) -- 2.3%
HEALTHCARE - LONG TERM CARE -
Addus Homecare (ADUS) - Services for elderly and disabled (248 mil) ------------------- 0%
Capital Senior Living (CSU) - Senior living communities (660 mil) ------------------------- 0%
Ensign Group (ENSG) - Skilled nursing and rehabilitative services (746 mil) ------------ 0.85%
HEALTHCARE - REITS -
Alexandria Real Estate Equities (ARE) - Life sciences lab space (26 Bil) -------------- 2.8%
CareTrust (CTRE) - Healthcare facilities REIT (2 Bil, 31, 3.67%) --------------------------- 3.67%
HCP Inc (HCP) - Healthcare facilities REIT (18 Bil) ---------------------------------------------- 6.2%
LTC Properties (LTC) - Healthcare facilities REIT (1.7 Bil, 11) ------------------------------- 5.1%
Medical Properties Trust (MPW) - Hospital REIT (13 Bil) ------------------------------------ 5.4%
National Health Investors (NHI) - Healthcare facilities REIT (3 Bil) ------------------------ 6.1%
Omega Healthcare (OHI) - Healthcare facilities REIT (5 Bil) ---------------------------------- 3.7%
Universal Health Realty Income (UHT) - Healthcare facilities REIT (1 Bil, 43) --------- 3.6%
Ventas (VTR) - Healthcare facilities REIT (23 Bil) ------------------------------------------------ 3.3%
Welltower (WELL) - Heathcare related properties REIT (29 Bil, 37) ------------------------ 4.7%
HEALTHCARE - MEDICAL DEVICES / EQUIPMENT -
Abiomed (ABMD) - Medical devices for cardiology (4.1 Bil) ----------------------------------- 0%
Align Technology (ALGN) - Invisalign orthodontics (8.6 Bil) ---------------------------------- 0%
Atrion (ATRI) - Medical equipment and supplies (725 mil) ------------------------------------ 0.8%
Becton Dickinson (BDX) - Medical devices, instruments, reagents (29 Bil) -------------- 1.7%
Cantel Medical (CMN) - Medical equipment (2 Bil) ---------------------------------------------- 0.2%
Cooper Companies (COO) - Contact lenses, medical devices for women's health (7.6 Bil)
CR Bard (BCR) - Medical, surgical, diagnostic products (11 Bil) ----------------------------- 0.6%
Cyberonics (CYBX) - Neuromodulation medical devices (1.8 Bil) --------------------------- 0%
Edwards Lifesciences (EW) - Medical devices, cardiac (37 Bil, 53) ------------------------- 0%
ICU Medical (ICUI) - Medical devices for infusion, oncology, critical care (1.8 Bil) ------- 0%
InMode Ltd (INMD) - Minimally invasive aesthetic medical products (3 Bil) (Israel) 0%
Inogen (INGN) - Portable oxygen concentrators (1.5 Bil) ---------------------------------------- 0%
LeMaitre Vascular (LMAT) - Medical devices for peripheral vascular disease (244 mil) 1.2%
Mazor Robotics (MZOR) - Surgical guidance systems (781 mil)
ResMed (RMD) - Products for sleep apnea (10 Bil) ---------------------------------------------- 1.6%
Teleflex (TFX) - Single-use medical devices (5.7 Bil) -------------------------------------------- 1.0%
Thermo Fisher Scientific (TMO)- Analytical instruments, equipment, reagents(50 Bil)0.49%
Vascular Solutions (VASC) - Products for cardiology, catheter systems (609 mil) ------ 0%
Varian Medical (VAR) - Medical devices for cancer, other conditions (8 Bil) -------------- 0%
HEALTHCARE - DISTRIBUTION -
Cardinal Health (CAH) - Drug and medical product distribution (27 Bil) -------------------- 1.8%
Dentsply (XRAY) - Dental products (7 Bil) ---------------------------------------------------------- 0.6%
Henry Schein (HSIC) - Dental / medical products (10 Bil) -------------------------------------- 0%
McKesson (MCK) - Pharmaceutical distribution, medical supplies, IT services (53 Bil) 0.4%
Owens & Minor (OMI) - Distributor of medical and surgical supplies (2 Bil) --------------- 3.0%
HEALTHCARE - ANALYTICAL / RESEARCH -
Mettler-Toledo Intl (MTD) - Precision instruments for diverse applications (8.3 Bil) ----- 0%
Perkin Elmer (PKI) - Diverse analytical technologies, products, svcs (5 Bil) --------------- 0.6%
Sigma Aldrich (SIAL) - Chemicals, biochemicals, and equipment (17 Bil) ----------------- 0.7%
Waters Corp (WAT) - Analytical instruments (10 Bil) --------------------------------------------- 0%
HEALTHCARE - CROs -
Icon PLC (ICLR) - Biopharma development outsourcing services (4.7 Bil) (Ireland) ----- 0%
Parexel Intl (PRXL) - Biopharma development outsourcing services (3.9 Bil) ------------- 0%
Quintiles (Q) - Biopharma development outsourcing services (9 Bil) ------------------------ 0%
HEALTHCARE - DIAGNOSTICS -
Abaxis (ABAX) - Blood analysis systems (1 Bil) -------------------------------------------------- 0.90
Agilent (A) - Bio analytical solutions and services (14 Bil) ------------------------------------- 0.9%
Bio-Rad Labs (BIO) - Biochemical analysis services for research, other (4.4 Bil) ------- 0%
Bio-Techne (TECH) - Biotechnology products and diagnostics (4 Bil) ---------------------- 1.3%
Genomic Health (GHDX) - Genomic based lab services for cancer (815 mil) ------------ 0%
Idexx Labs (IDXX) - Veterinary diagnostic products and services (6 Bil) ------------------- 0%
Lab Corp of America (LH) - Diagnostic testing services (12 Bil) ----------------------------- 0%
Neogen (NEOG) - Food safety testing (2 Bil) -------------------------------------------------------- 0%
NeoGenomics (NEO) - Cancer-focused testing laboratories (397 mil) ----------------------- 0%
Quest Diagnostics (DGX) - Diagnostic testing services (9.7 Bil) ---------------------------- 2.3%
HEALTHCARE - DRUGS -
AbbVie (ABBV) - (96 Bil) - Research unit from Abbott Labs ( Bil) ---------------------------- 3.4%
Amgen (AMGN) - Biotechnology (129 Bil) --------------------------------------------------------- 1.9%
AstraZeneca (AZN) - Pharmaceuticals (89 Bil) --------------------------------------------------- 2.7%
Biomarin (BMRN) - Biotechnology (20 Bil) --------------------------------------------------------- 0%
Bristol Myers Squibb (BMY) - Parmaceuticals (104 Bil) --------------------------------------- 2.3%
GlaxoSmithKline (GSK) - Pharmaceuticals (115 Bil) ------------------------------------------- 5.9%
Novartis (NVS) - Pharmaceuticals (244 Bil) ------------------------------------------------------- 2.9%
Novo Nordisk (NVO) - Pharmaceuticals (129 Bil) ----------------------------------------------- 1.6%
Pfizer (PFE) - Pharmaceuticals (203 Bil) ----------------------------------------------------------- 3.4%
Taro Pharmaceuticals (TARO) - Pharmaceuticals, OTC, generic (Israel) (6 Bil) -------- 0%
Valeant (VRX) - Pharmaceuticals, OTC products, medical devices(Canada) (80 Bil) --- 0%
Zoetis (ZTS) - Veterinary drugs and vaccines (24 Bil) ------------------------------------------- 0.7%
HEALTHCARE - DRUG - MISC -
Cambrex (CBM) - Active pharmaceutical ingredients (1 Bil) ----------------------------------- 0%
West Pharmaceuticals (WST) - Drug packaging and delivery systems (4.1 Bil) ------- 0.81%
HEALTHCARE - DRUG DISTRIBUTION -
Amerisource Bergen (ABC) - Drug distribution (17 Bil) --------------------------------------- 1.25%
CVS Caremark (CVS) - Drugstores, retail products (91 Bil) ----------------------------------- 1.4%
HEALTHCARE - GENERIC DRUGS -
Dr. Reddy's Labs (RDY) - Generic drugs (9 Bil) -------------------------------------------------- 0.5%
Mylan Labs (MYL) - Generic drugs (25 Bil) -------------------------------------------------------- 0%
Teva (TEVA) - Pharmaceuticals, Israel (53 Bil) --------------------------------------------------- 2.2%
HEALTHCARE - ANTIBIOTICS -
Innovation Pharma (IPIX) - Broad spectrum antibiotic, antiviral, antifungal, anti-inflamatory (Brilacidin)(100 mil)
Cempra (CEMP) - Antibiotics (1.6 Bil) --------------------------------------------------------------- 0%
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MORE -
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HealthStream (HSTM) - Internet-based learning, talent mgt, and research solns
National Research (NRCIB) - Performance measurement services (258 mil)
Novadaq Technologies (NVDQ) - Fluorescence imaging products and devices, Canada
Perrigo (PRGO) - Generic / OTC drugs, consumer healthcare products (11 Bil)
PetMed Express (PETS) - Veterinary drugs and health products (264 mil)
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ACQUIRED -
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Allergan (AGN) - Generic drugs, other (acquired by Abbvie 2019)
Express Scripts (ESRX) - Phamacy benefit management (acquired by Cigna 2018)
VCA Antech (WOOF) - Veterinary hospitals (Mars)
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