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ASCO ’22 preview: Putting patients first

For the first time since 2019, the American Society of Clinical Oncology (ASCO) annual meeting will be an
The post ASCO ’22 preview: Putting patients…

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For the first time since 2019, the American Society of Clinical Oncology (ASCO) annual meeting will be an in-person conference. We’re excited to re-connect with fellow oncology and clinical care professionals from across the globe to learn from one another and discuss key advances in cancer care and research.

From innovations in cancer therapeutics to developments in genetic testing and biomarkers to the role of data analytics and technologies in oncology trials, insightful conversations can create invaluable intersections between trial sponsors, researchers, service partners and patients, breaking down information silos to promote advances in patient-driven drug development.

More than ever, patients and their advocates are ready to play an integral role in oncology healthcare. The industry can best make a genuine impact in clinical outcomes when the patient’s needs and experiences are integrated into drug development. ASCO ’22 provides the perfect backdrop to dive into ways we can collectively drive patient-centric oncology research and development (R&D). Highlighted below are a few of the key patient-focused discussions we look forward to at ASCO.

Equitable care for all

Our industry hopes trial participation provides answers to the compelling questions in oncology care, while offering patients innovative treatment pathways. However, we’re falling short on our mission to ensure that the population recruited into trials sufficiently represents all those affected by cancer in the real world. The disproportionate impact of COVID-19 on racial and ethnic minorities allowed the need for health equity and clinical research as a care option for all to take centre spotlight. It also highlighted the individualised day-to-day burdens on patients and caregivers that impact access to care and life-saving treatments. Often, trial participation may require resources which are not always available to patients from lower socioeconomic groups, remote geographies or certain ethnicities. This contributes to a disparity in participation and may impact the ability to apply the results of oncology clinical trials to clinical practice.ASCO attendees have the chance to sit in or actively participate in several meaningful sessions focused on equitable cancer care, including discussions on increasing trial participation and interest among African-American populations and removing barriers to treatment access.

To better address barriers to oncology trial participation, the industry needs to shift how we’ve approached the issue by first identifying various burdens, then incorporating solutions directly into trial design accordingly.

During the pandemic, decentralised trial (DCT) solutions helped improve patient engagement and increased trial efficiencies. Scalable DCT solutions (e.g., telehealth, wearable devices, at-home lab collection and direct-to-patient (DTP) treatment delivery) helped reduce certain patient burdens related to access and open participation to a more geographically, and hence a potentially more racially and ethnically diverse patient population. Although the DCT approach requires participants to assume certain responsibilities typically owned by sites, by including strategies to drive patient understanding and compliance, these burdens can be offset and oncology clinical research can flourish in the new paradigm.

Applying COVID-19 key learnings

During the early days of the pandemic, the industry appropriately focused on how to make sure critical drug development continued despite site closures, regional shutdowns and increased patient safety concerns. Now, it is important that the oncology community endeavors to understand which innovative solutions worked well during COVID-19 and to tailor those strategies for future clinical trials for patients with cancer.

For example, telehealth helped ensure patients in oncology trials were able to continue participating from home and accessing much-needed investigational treatments, while limiting exposure to COVID-19 by reducing on-site visits for complex medical procedures. For those with cancer, this can greatly impact their quality of life and potentially impact survival. Therefore, when utilising telehealth, one must account for impacts on supportive care. If patients don’t physically visit with their provider as often, how should we ensure they are getting the same level of support, and what adjustments in trial design and protocol should be made to ensure quality care? At ASCO, stakeholders are expected to discuss what conducting an oncology trial after COVID-19 may entail, touching on supportive care differences, like patient isolation, that can impact trial outcomes.

Integrating new drugs into cancer care

Over the past decade, there were nearly 170 new treatments in immuno-oncology, next-generation biotherapeutics, treatments for rare cancers and more. We’ve also seen an increase in centres and trial sites globally that extend the availability of these treatments to patients. Taking chimeric antigen receptor (CAR) T-cell therapies for example, there are a growing number of centres in the U.S. and elsewhere worldwide offering the treatment. Those in clinical care at ASCO will share insights on the real world use of these therapies and variations per patient population, region, and more.

Whether treatments for more common forms of cancer (e.g., breast cancer, non-small cell lung cancer, prostate cancer) or rare cancers, the uptake of use for an approved treatment can vary greatly from country-to-country. Differences in reimbursement pricing and much more can impact treatment use per country, which in turn, can influence where future trials are conducted and related outcomes. Securing real world data insights can help inform key decisions around future drug development and trial planning, which will be discussed at ASCO too.

ASCO has always offered those of us in the complex field of oncology R&D a tremendous opportunity to celebrate the collective progress the industry has made in ensuring high-quality care to those most at need. By embracing innovation and staying agile in approaches, we can help make sure the greatest number of patients are able to capitalise on breakthrough therapies, our shared goal in cancer care.

Here’s to all the insightful discussions we will have at ASCO to better meet patient needs!

About the authors

As chief medical officer, Dr. James Kyle Bryan is responsible for strategic global medical and scientific leadership for IQVIA Biotech, leading the Medical, Safety, Feasibility, Oncology Strategy and Global Strategic Delivery teams.

Focused on drug discovery and development in the biotechnology and pharmaceutical industries for more than 25 years, Kyle offers a unique perspective on navigating medical and safety challenges and needs within clinical trials. Board-certified in haematology and medical oncology, Kyle also remains actively engaged in clinical care as a clinical faculty member at the University of Washington Medical Center, allowing him to better understand the current needs and wants of patients to factor into his guidance for trial sponsors.

Head of the Hematology/Oncology Center of Excellence at IQVIA, Dr. Jeffrey Keefer is a board-certified paediatric haematologist and oncologist with 12 years of academic faculty experience in the Johns Hopkins University School of Medicine’s Division of Pediatric Hematology. Prior to his current role, he led the Pediatric and Rare Diseases Center of Excellence at IQVIA.

Dr. Keefer received a BA in Biology from the University of Virginia and MD and Ph.D. degrees from Vanderbilt University School of Medicine. He completed a residency in Paediatrics and served one year as Chief Resident at the Johns Hopkins Hospital, where he held a Fellowship in Pediatric Hematology and Oncology.

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A Climate Of Fear

A Climate Of Fear

Authored by James Gorrie via The Epoch Times,

The medical, media, and political elites’ focus has shifted from facts…

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A Climate Of Fear

Authored by James Gorrie via The Epoch Times,

The medical, media, and political elites’ focus has shifted from facts to fomenting and magnifying fear.

In Franklin D. Roosevelt’s first inaugural address in 1933, the new president told a nation in the depths of the Great Depression that “the only thing we have to fear is fear itself.”

Those words were true and rightfully spoken at that time. Roosevelt knew that fear is a powerful emotion that limits our ability to reason, act wisely, and work together. It’s also an emotion that’s contagious and not easily diminished or dissipated.

The Power of Fear to Fragment Society

Unfortunately, Roosevelt’s words are even more applicable today.

On a personal level, decisions made under the emotional duress of fear are rarely the best ones and often the worst. Fear can bring out the best in us, but can often bring out the worst. That’s more likely to occur the more fragmented a society becomes. Fear among different groups of people creates an us-versus-them context in the minds of individuals, or even an “every-man-for-himself” attitude, which pits one group against another or even each of us against each other.

Now elevate that sense of fear to the level of the national electorate. A people or a nation that's paralyzed with fear makes rash decisions based on their fears of what could happen, not necessarily what the current situation truly is. When that happens, a society can quickly degenerate, where our base instincts determine our behavior in a law-of-the-jungle social environment.

Roosevelt knew this, as do our leaders today. The difference is that today, rather than seeking to dispel fear, our political and media elites create it, expand it, and revel in it. Rather than promote hope and strength of character in us, in a Roosevelt- or even a Reagan-like fashion, they traffic in fear and its fellow traveler social division in order to fragment our society.

It’s the old but effective divide-and-conquer strategy, and sadly, it works far too well. The mechanism for divide and conquer is the constant drumbeat of the Big Lie, which is also a tried and true method for controlling society. It was first practiced and perfected by Joseph Goebbels in Nazi Germany using the mass media, but has been successfully used by the USSR and every other communist and dictatorial regime in the world since the 1930s.

Social Media Is Magnitudes More Powerful Than Legacy Media

The difference today is the massive and pervasive presence of social media. Its reach and social saturation throughout society are magnitudes greater than have ever been possible before. What’s more, our political and media elites create and exaggerate fear without even mentioning the word. “Fear” is driven into our collective psyches under the guise of our government keeping us “safe,” while demonizing anyone who challenges that narrative.

The repetition by the media and the pharmaceutical industry of how to stay safe from COVID-19 always involves more drugs and less freedom. That’s by design. The elites that run society know that once enough of our friends, neighbors, coworkers, and others with whom we interact become more fearful than rational, they’re easily manipulated and divided into confrontational groups.

Does that sound like a conspiracy theory?

Yes, it probably does, but it’s also how the Stasi, the East German security agency, turned virtually every neighbor into an informant. The result was that people were fearful of doing anything that could be construed as being against the communist East German government. In light of what we’ve been through the last three years—and what looks to be on the horizon—the conspiracy theory accusation has lost its sting.

From Conspiracy Theory to Fact

Recall, for example, how those who received the COVID-19 vaccine turned against those who remained unvaccinated. The contrast and social division couldn’t have been clearer or more deliberate. Vaccinated people were characterized by the media and government agency spokespeople as selfless, smarter, and better human beings than those who refused the vaccine.

On the flip side, the “anti-vaxxers,” as they came to be called, were publicly derided by the medical, pharmaceutical, media, and government elites. They were accused of being low-intelligence conspiracy theory nuts who wouldn’t or couldn’t “follow the science,” even when they followed the science from experts such as Robert Malone, one of the inventors of the mRNA technology, and other medical doctors in Europe and Asia, including former Pfizer Vice President Dr. Michael Yeadon, all of whom were de-platformed from mainstream media and social media.

In fact, any “alternative” remedy to the experimental and highly dangerous mRNA vaccines, such as ivermectin, was summarily dismissed, even though nations that used ivermectin had the lowest mortality rates. As noted above, many media personalities and even medical experts with contrary opinions were silenced, shamed, and shunted into professional oblivion, being substituted by compliant replacements. That practice continues to this day, with Russell Brand being the latest example of being de-monetized by YouTube.

In light of vaccine injuries and deaths, and the staggering profits that vaccines have delivered to the pharmaceutical industry, the number of people who believe the mainstream media, the government, and in the vaccines, is much smaller today than three years ago.

Conspiracy theory narratives have become conspiracy facts.

The Endgame of Fear

So, what’s the endgame of promoting and enforcing a climate of fear throughout society?

It’s simple. Fearful people are far more compliant and, therefore, are easily controlled, pacified, monitored, and dehumanized. Next thing you know, we’ll all be eating bugs and liking it.

The antidote to fear, of course, is freedom and access to real and contrary information so that each person can make up his or her own mind. The encouragement, enablement, and empowerment of private individuals to exercise informed judgment about their health and their livelihoods are also part of the solution. A vibrant, thinking, and active society of informed individuals isn't nearly as vulnerable to the polarizing climate of fear our elites are foisting upon us.

In short, to live in fear is to live in bondage.

Tyler Durden Sat, 09/30/2023 - 20:50

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COVID-19 Vaccine Found In The Hearts Of Dead People: Study

COVID-19 Vaccine Found In The Hearts Of Dead People: Study

Authored by Zachary Stieber via The Epoch Times (emphasis ours)

COVID-19 vaccine…

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COVID-19 Vaccine Found In The Hearts Of Dead People: Study

Authored by Zachary Stieber via The Epoch Times (emphasis ours)

COVID-19 vaccine was detected in patients who died within a month of vaccination, according to a new study.

COVID-19 vaccines in Massachusetts in a file image. (Joseph Prezioso/AFP via Getty Images)

U.S. researchers analyzed tissue samples from the autopsies of 25 people, including 20 who were vaccinated.

Samples from the hearts of three patients, all of whom died within 30 days of a Pfizer shot, tested positive for messenger ribonucleic acid (mRNA).

Eight bilateral axillary lymph node samples, from people who died within 30 days of a Moderna or Pfizer vaccine, also tested positive. The companies' shots utilize mRNA.

The research shows "the vaccine can persist for up to 30 days, including in the heart," Dr. James Stone, with the departments of pathology at Massachusetts General Hospital and Harvard Medical School, told The Epoch Times via email.

The study was published by npj Vaccines. Authors declared no conflicts of interest. They said the research was supported by Massachusetts General Hospital, which is in Boston.

In testing of heart and bilateral axillary lymph node tissues from other vaccinated people who died, no vaccine was detected.

Additionally, no vaccine was detected in the liver, spleen, or mediastinal lymph nodes—vaccine was detected in the liver and spleen in preclinical rodent studies before—nor was any detected in tissues from the unvaccinated patients.

The Pfizer and Moderna vaccines are known to cause myocarditis, a form of heart inflammation that can result in death.

The people who had mRNA detected in the heart did not have myocarditis, though they did have detectable heart injuries, researchers found.

The researchers said they believed the heart injuries stemmed from underlying diseases and not the vaccines.

"There is no indication as yet that the vaccine in the heart is causing any problems in these patients; neither the causes of death nor the causes of the myocardial injury were linked to the vaccines in that study," said Dr. Stone, one of the authors of the paper.

A health care worker prepares a dose Pfizer/BioNTEch COVID-19 vaccine at The Michener Institute, in Toronto, Canada, on Dec.14, 2020. (Carlos Osorio/POOL/AFP via Getty Images)

That position was challenged by Dr. Clare Craig, a British pathologist who reviewed the research.

"The vaccine should not have been there. There was evidence of heart damage. Those three people are now dead," Dr. Craig told The Epoch Times in a message.

She said the researchers were setting too high of a bar for causality.

"At postmortem if there is significant narrowing of the coronary arteries then heart damage is attributed to it on the balance of probabilities. Here this is a clear cut association, an unusual picture of myocardial injury, and a failure to call it out for what it is," Dr. Craig said.

More on Research

The tissues were collected from autopsies performed between January 2021 and February 2022 at the Massachusetts General Hospital. Researchers excluded tissues from some dead people, including from patients who had no clear history of vaccination or non-vaccination and those who had a documented prior COVID-19 infection.

The researchers wanted to test the tissue for vaccine in light of research that has found both spike protein and mRNA persisting in axillary lymph nodes and blood for weeks or even months after vaccination. The testing would help "gain a better understanding of the biodistribution and persistence of SARS-CoV-2 mRNA vaccines," they said. SARS-CoV-2 is the virus that causes COVID-19.

Researchers ended up with tissues from 20 vaccinated patients, including six who received one dose, 12 who received two doses, and two who received three doses. They also formed a control group of five unvaccinated patients.

Six bilateral axillary lymph node samples were available for people vaccinated with Moderna's shot. Two tested positive for the vaccine. Thirteen were available for people vaccinated with Pfizer's shot. Six tested positive for the vaccine.

Overall, of the 11 bilateral axillary lymph node samples from patients who died within 30 days of a shot, eight tested positive. None of the samples from patients who died beyond 30 days of vaccination tested positive.

Researchers also examined samples from each of the vaccinated people from the cardiac left ventricle and cardiac right ventricle. Of those, four samples tested positive across three patients. These were the three who received Pfizer's shot within 30 days of dying. The samples also tested negative for COVID-19.

Vaccine was not detected in any of the unvaccinated people.

The vaccinated patients were on average older, with a mean age of 64 compared to 57. A higher percentage—55 percent to 20 percent—had recent heart injury.

Read more here...

Tyler Durden Fri, 09/29/2023 - 18:20

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T2 Biosystems (NASDAQ: TTOO) Breaks Ground: FDA Clearance, Market Trends, and Healthcare Impact

Shares of T2 Biosystems (NASDAQ:TTOO) are soaring up over 20% today on the heels of receiving a 510(k) clearance for its T2Biothreat from the FDA. This…

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Shares of T2 Biosystems (NASDAQ:TTOO) are soaring up over 20% today on the heels of receiving a 510(k) clearance for its T2Biothreat from the FDA. This unique test directly detects six biothreat pathogens from a blood sample.

Spotting Biothreats Faster:

T2Biothreat Panel is a game-changer, being the first and only FDA-approved product that can spot these critical biothreat pathogens simultaneously. T2 Biosystems proudly stands as the first U.S. company to achieve this milestone, reshaping the field of biothreat detection.

Big Investor Sells:

Interestingly while celebrating this achievement, a significant investor, CR Group (CRG), decided to sell off a substantial chunk of shares. This sell-off, totaling 24.81 million shares, took place between Sept. 20 and Sept. 26. The timing of this sell-off alongside the FDA clearance raises some eyebrows.

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New CDC Guidelines:

Regardless of CR Group selling, there still appears to be a massive opportunity according to many retail investors. Following new CDC guidelines, the U.S. government now mandates that all hospitals in the country must adopt rapid testing protocols to combat the sepsis pandemic by 2026, or risk losing Medicare funding.

Buying opportunity of the year!!! Update
byu/den1183 inTTOOstock

T2 Biosystems stands as the exclusive FDA-cleared product capable of achieving 100% accurate sepsis detection within 3 to 5 hours. Anticipating widespread adoption of T2 instruments in hospitals, the CEO foresees significant revenue generation, potentially reaching $1.3 billion annually, given the mandate.

This development drastically alters the landscape, potentially influencing the stock’s trajectory positively. With the ongoing surge in manufacturing hires and likely acceleration in orders, coupled with potential government contracts or international sales, many beleive T2 Biosystems presents an undervalued opportunity for investors.

What Borrowing Costs Tell Us:

Another interesting indicator to look at is the cost to borrow (CTB) fee. In terms of TTOO’s case, the stock has seen a massive surge in CTB fees, indicating a high demand from short sellers. When compared to the average CTB fee for other stocks, it’s pretty drastic. While this is typically not a very positive sign, retail investors seem to be buzzing with interest, given there also could be a potential short squeeze if enough buying comes in to trap the shorts.

Better News for Patients:

But let’s not forget the real impact and that’s what TTOO can do for patients. @ChengKeki a user from Twitter also shared an article about Butler Memorial Hospital and their approach to Sepsis. The hospital came up with a 2 step approach to expedite patient care.  They’re utilizing the Beckman Coulter automation line to identify changes in a person’s blood cells that might indicate the development of sepsis. Which apparently has only been used in Europe and they’re the first in the US with the technology. Then shortly after, they use T2 Biosystems panels that as you know, quicken the process from 36 hours, to just 3-5 hours.

Catching sepsis quickly is crucial because it’s a life-threatening condition that rapidly progresses throughout your body and can lead to death if not promptly diagnosed and treated. Sepsis occurs when the body responds improperly to an infection, causing widespread inflammation and potentially damages multiple organ systems. Early detection allows for immediate medical intervention.

Conclusion:

T2 Biosystems is hitting major milestones, not only in the market but in improving critical healthcare processes. The company is also a major hit with retail investors and continues to trade an astronomical amount of shares daily, the current average is ~115M shares. The FDA approval and its implications, along with the positive shift in sepsis diagnosis, showcase T2 Biosystems’ growing role in healthcare. Keep an eye on how this progresses—it’s exciting for both investors and patients alike.

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Picture by jarmoluk from Pixabay

 

The post T2 Biosystems (NASDAQ: TTOO) Breaks Ground: FDA Clearance, Market Trends, and Healthcare Impact first appeared on Micro Cap Daily.

The post T2 Biosystems (NASDAQ: TTOO) Breaks Ground: FDA Clearance, Market Trends, and Healthcare Impact appeared first on Micro Cap Daily.

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