This research includes understanding inherited cancer risks and an immunotherapy dosing study.

Fred Hutchinson Cancer Center is focused on the application of advanced research to provide the latest cancer treatment options while accelerating discoveries that prevent, treat and cure cancer and infectious diseases worldwide. The institution is based in Seattle, and as well as cancer treatments the body has undertaken advances in bone marrow transplantation, immunotherapy, HIV/AIDS prevention and COVID-19 vaccines.

Hereditary cancers

Genetic testing for hereditary cancer risk has become more accessible and, based on the findings, more important than ever. This is because around 5-10 percent of cancers are thought to be hereditary.

It also stands that advancements in germline testing can offer accurate, affordable ways to identify these risks. Germline testing helps individuals with early cancer management and it also aids biological family members in understanding their own risk.

While the process involves a simple clinic visit for a DNA sample, it differs significantly from commercial, direct-to-consumer tests as the comprehensive assessments and genetic counseling help patients make informed decisions for personalized screening, treatment and lifestyle changes.

Immunotherapy frequencies, costs and benefits

In the second core research area, the Fred Hutchinson scientists have found that reducing the frequency of immunotherapy dosing could save money and time, keep patients on therapy longer.

ICIs have transformed care for patients with aggressive skin cancers like melanoma and Merkel cell carcinoma, however, more research is needed to understand how these findings might impact long-term treatment plans.

Racism in cancer treatment

Another area of new research is with health equity, including an examination of racism in cancer care. For this line of inquiry, Fred Hutch partnered with the Cierra Sisters, a Seattle-based patient advocacy group, to produce a series of short videos to acknowledge and address the racism many women of color experience while dealing with breast cancer.

The findings indicate that some women report that racism begins when they approach their general practitioner with a concern and persists throughout diagnosis, cancer treatment and pain management.

This has led to the development of the Anti-Racism in Oncology project. The aim is to highlight the issue by capturing video-based stories of real people having conversations about racism in health care.

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The AI application comes from the Icahn School of Medicine at Mount Sinai. Here medical scientists have harnessed AI to enhance the assessment of the heart’s right ventricle, which sends blood to the lungs.

Conducted by a team using AI-enabled electrocardiogram (AI-ECG) analysis, the research demonstrates that electrocardiograms can effectively predict right-side heart issues, offering a simpler alternative to complex imaging technologies and potentially enhancing patient outcomes.

The research found that a deep learning-based ECG analysis tool is able to identify patients at high risk for poor right ventricular function. Areas deemed important by the AI for prediction are highlighted in increasing shades of red.

According to lead researcher Son Q. Duong: “We aimed to find a better way to assess the health of the heart’s right ventricle, focusing on its ability to pump blood and its size. Traditional methods fall short, which prompted us to explore AI-ECG analysis as a potential solution.”

The medic adds: “This novel method could expedite the identification of heart problems, especially in the right ventricle, and potentially lead to earlier and more effective treatment. It holds particular importance for patients with congenital heart disease, who often face issues in the right ventricle.”

To achieve this breakthrough, the researchers trained a deep-learning ECG (DL-ECG) model using harmonized data from 12-lead ECGs and cardiac magnetic resonance imaging (MRI) measurements. It was conducted on a large sample from the UK Biobank and validated at multiple health centres across the Mount Sinai Health System, measuring its accuracy in predicting heart conditions and its impact on patient survival rates.

Despite the success, the researchers say that while the use of artificial intelligence allows for more precise heart information from commonly available tools, it is in an early stage and doesn’t replace advanced diagnostics. Further work is needed to ensure the tool’s safety and correct applicability. Furthermore, the study’s predictions may vary across populations, relying on existing ECG and MRI data with inherent limitations. Its application in everyday clinical practice requires further exploration, cautioned the researchers.

The research has been published in the Journal of the American Heart Association. The research paper is titled “Quantitative Prediction of Right Ventricular Size and Function From the ECG.”

The study was supported by the U.S. National Heart, Lung, and Blood Institute, National Institutes of Health and National Center for Advancing Translational Sciences.

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With the announcement, Health Canada has approved the medicine BEQVEZ (fidanacogene elaparvovec). The medication is an adeno-associated viral (AAV) vector-based gene therapy drug for the treatment of adults (aged 18 years or older) with moderately severe to severe haemophilia B (otherwise known as congenital Factor IX deficiency). This is suitable in patients who are negative for neutralizing antibodies to variant AAV serotype Rh74.

Although strange sounding, the medication – fidanacogene elaparvovec  – is a novel, investigational gene therapy that contains a bio-engineered AAV capsid and a high-activity variant of human coagulation FIX gene.

Adeno-associated viruses (AAV) are small viruses that infect humans and some other primate species. AAV is an attractive candidate for creating viral vectors for gene therapy, being used by molecular biologists to deliver genetic material into cells.

According to scientist Frédéric Lavoie, Canada Lead – Specialty Business Unit, Pfizer Canada ULC: “We are proud to introduce an innovative therapy for people living with haemophilia B in the form of gene therapy.”

Human gene therapy has been advancing in recent years and relates to technologies developed for the treatment of disorder or disease through transfer of engineered genetic material into human cells, often by viral transduction.

Health Canada’s approval for BEQVEZ was based on an open label, single arm Phase 3 BENEGENE-2 study, to evaluate the efficacy and safety of fidanacogene elaparvovec in adult male participants (age 18–65) with moderately severe to severe haemophilia B.

Haemophilia B is a blood clotting disorder causing easy bruising and bleeding due to an inherited mutation of the gene for factor IX (the absence of which causes the blood to take a long time to clot). Most individuals who have Haemophilia B and experience symptoms are men and Haemophilia B represents about 15 percent of patients with haemophilia.

The main objective of the study was to evaluate the annualized bleeding rate for participants treated with gene therapy versus FIX prophylaxis replacement regimen, administered as part of usual care. The study enrolled 45 participants.

The new treatment shows potential in reducing the burden of frequent infusions by providing, with a single infusion, a persistent liver production of factor IX, which could help improve the life of those affected.

Based on the World Federation of Haemophilia, more than 38,000 people worldwide were living with haemophilia B in 20211. In Canada, haemophilia B affects over 700 individuals.

The goal of the gene therapy for eligible people living with haemophilia B is that, once treated, they will be able to produce FIX via this one-time treatment, rather than having to regularly receive intravenous FIX produced from either plasma or recombinant technology.

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Looking at some of these challenges and notifying the trends to Digital Journal is Simon Johns, who is the Director of Medical Information and Marketed Product Safety at the regulatory intelligence firm IQVIA.

Johns  begins by looking at information growth: “The continuously growing volume of Medical Information case inquiries will not cease in 2024, especially as it is effectively the only inbound communication channel remaining for pharmaceutical companies.”

Medical information is a wide ranging term, meaning any information regarding an individual’s medical history, mental or physical condition, or medical treatment or diagnosis by a healthcare professional. Such data is not only critical to patient health it is also of great value for companies.

Can the complexity and voluminous nature of this information be moderated by the use of technology, specially AI?

In answering this important question, Johns things the changes will be for the better: “Artificial intelligence (AI) will be relied on to help manage the growing case volume. Although AI is not a novel concept within the pharmaceutical industry, the introduction of new systems and tools – like generative AI – will push companies to revisit their current applications to automate traditionally manual tasks.”

This will lead to some sectoral changes. Predicting the fork these will take is not straightforward. Seeking to understand the patterns, John observes: “In 2024, the industry, specifically within the Medical Information area, will see shifts to multi or even omni channel models to ensure that healthcare professionals and patients have available means of communication with pharmaceutical companies when necessary.”

Citing an example, Johns uses bots: “AI chatbots will first be applied to this area in the form of warm transfers – if a call centre is experiencing a surge in calls and all human agents are occupied, AI agents will emerge as a backup. These chatbots would then be able to transfer the inquiry to a human agent when available or needed. Fully automated processes will be phased in. Against some beliefs that this process will replace agents, AI will be a tool for agent assistance and faster response.”

The world of pharmaceuticals is heavily regulated and therefore the adoption of nay technology needs to be performed in a controlled manner, extending to the nece3ssity of keeping things compliant. Johns coincides with: “Maintaining compliance is a priority for pharmaceutical organizations, and while the gradual integration of AI processes may seem like a large endeavour, organizations will begin to see the benefits in the upcoming year.”

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Per an analysis by the firm Formrush, ten states logged the greatest single-year spikes in adult obesity rates from 2022 to 2023. These were: Delaware, Wisconsin, Tennessee, Washington, Georgia, Wyoming, Nevada, Arizona, Idaho, and Montana.

While no population has proven immune as obesity surpasses prior records, the escalation in these locales presents a need to intensify health actions. Many individuals face heightened jeopardy of diabetes, cardiovascular conditions, and other challenges posed to overburden families and support systems.

Consequently, authorities and communities should begin to critically re-examine strategies, rally resources, and renew communal commitments to bend the obesity curve groundward.

In terms of the impacted areas:

At the top is Delaware, where adult obesity has risen by 11.7 percent. Here, 35.3 percent of adult men and an even higher 40.5 percent of adult women in the state now have obesity. In the state, 18.5 percent of young children and 13.4 percent of older children face obesity. Targeted intervention is needed before the epidemic progresses further out of control.

More specific data relating to Delaware is:

In second place is Wisconsin, where adult obesity has increased 11.2 percent in the past year alone. In addition 25.5 percent of children ages 10-17 in the state also have obesity. In third spot is Tennessee where adult statistics showcase disparities – 35.1 percent of men have obesity compared to a much higher 42.7 percent rate among women.

To identify the top ten states with the greatest single-year adult obesity rate increases, obesity rate data was gathered from state and national public health surveillance systems for the years 2018 through 2022. State-level adult obesity prevalence statistics were compiled and verified from official government public health sources to ensure accuracy and consistency of reporting.

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Scheduling a doctor’s appointment can be challenging. Getting to that appointment can be downright difficult. As Americans are getting older and driving less, health care providers are faced with a big problem: up to 50% of all medical appointments in the US are no shows. A no show is defined as an appointment that isn’t canceled but for which the patient simply doesn’t show up. 

It is particularly true that barriers to safe and reliable transportation for senior citizens and the disabled have impacted their ability to get the care they need. Their options for transportation, if not carried out by a friend or loved one, have been price sensitive regional services and national rideshare companies, rarely given praise by the patients themselves. 

Kerico Health Care, a Houston based Non-emergency Medical Transportation (NEMT) company, is taking a different approach by focusing on the patient experience above all. Founded in 2018 by Michael Morris, a serial entrepreneur whose own experience of being unable to find reliable transportation for his ailing mother when she was being treated for cancer, was a wake up call. “I just didn’t trust some stranger in a rideshare to transport my mom across town and drop her off on the curbside of a medical building. And I knew that if I didn’t want that, and she didn’t want that, then millions of Americans were feeling the same way.”

Morris started Kerico with a new approach. Firstly, to partner directly with doctors’ offices to transport patients at their request. The clinic-as-the-customer approach wasn’t new per se, but Morris took it a step further. “I wanted to create a door-through-door service. We can literally help a patient from their couch to the vehicle, get them across town, help them into the doctor’s reception area, and vice versa for the ride home, and we track every movement via our care coordination team and our app.”

Chris Ochs, Kerico’s Chief Development Director expands on this. “What health care providers are recognizing is that it is common for an NEMT driver to spend more time with a patient than that patient will spend with their physician, and therefore the driver-patient interaction is of critical importance. The drive to and from the appointment is part of the patient experience. That’s why we train our drivers not just on safety, but on patient empathy and understanding.”

This approach for Kerico to become the gold standard for NEMT in the US is paying off. The company has grown 300% year-over-year due to its earning the trust of healthcare giants United Health Group and Houston Methodist. Morris shares his final thoughts. “When it comes to NEMT, we are moving from a price-conscious world to a care-conscious world. And it’s a beautiful thing when the patient, their families, and their doctors don’t need to worry about transportation the same way I did when caring for my mom. We’re heading in the right direction and are proud to lead the way.”

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Currently, a doctor will estimate chance of rupture based on risk factors (such as age or smoking history) and the size of the aorta. If the aorta starts to grow too quickly or become too large, then a patient often will undergo a surgical graft to reinforce the vessel wall, an invasive procedure that carries its own risks. The new method provides a workable alternative.

This research breakthrough is based on researchers discovering the physical mechanism underlying aortic aneurysm. The researchers were able to forecast abnormal aortic growth by measuring subtle “fluttering” in a patient’s blood vessel. As blood flows through the aorta, it can cause the vessel wall to flutter. The researchers say this is similar to how a banner ripples in the breeze.

Under these conditions, when an artery swells to form an aneurysm, the arterial wall weakens. Consequently, the interaction between this weakened wall, high blood pressure, large aortic size, and so on causes the artery wall to flutter irregularly. This was based on extensive mathematical work and analyses.

The Northwestern University scientists were the first to quantify this flutter instability, which signals need for intervention before artery ruptures. While stable flow predicts normal, natural growth, unstable flutter is highly predictive of future abnormal growth and potential rupture, the researchers found.

According to lead scientist, Neelesh A. Patankar: “The fundamental physics driving aneurysms has been unknown. As a result, there is no clinically approved protocol to predict them. Now, we have demonstrated the efficacy of a physics-based metric that helps predict future growth. This could be transformational in predicting cardiac pathologies.”

The researchers have named this phenomenon the “flutter instability parameter” (FIP). To calculate a personalized FIP, patients only need a single 4D flow magnetic resonance imaging (MRI) scan. If a patient is at risk, a physicians could potentially prescribe medications to high-risk patients to intervene and potentially prevent the aorta from swelling to a dangerous size.

To quantify the transition from stability to instability, the researchers combined blood pressure, aorta size, stiffness of the aortic wall, shear stress on the wall and pulse rate. The resulting number (or FIP) characterizes the exact interaction between blood pressure and wall stiffness that ultimately triggers fluttering instability.

To test the new metric, the researchers reviewed 4D flow MRI data from 117 patients who underwent cardiac imaging to monitor heart disease and from 100 healthy volunteers. Based on this MRI, the researchers assigned each patient a personalized FIP.

The research has been published in the journal Nature Biomedical Engineering, titled “Blood-wall fluttering instability as a physiomarker of the progression of thoracic aortic aneurysms.”

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A biological insight has shown, based on brainstem recording, how our tastebuds are the first line of defence against eating too fast. This new understanding could lead to new avenues for tackling weight loss.

University of California – San Francisco researchers demonstrated this by stimulating the perception of flavour to pinpoint a set of neurons that function to curtail our food intake.

According to lead researcher Zachary Knight the results could be significant: “We’ve uncovered a logic the brainstem uses to control how fast and how much we eat, using two different kinds of signals, one coming from the mouth, and one coming much later from the gut. This discovery gives us a new framework to understand how we control our eating.”

Using an animal model, the researchers used imaging and recording to reveal the brainstem structure critical for feeling full. This is termed the nucleus of the solitary tract, or NTS.

It was demonstrated that when food is put directly into a mouse’s stomach, brain cells called PRLH (for prolactin-releasing hormone) are activated by nutrient signals sent from the GI tract.

When the scientists allowed the mice to eat the food as they normally would, those signals from the gut did not show up. Instead, the PRLH brain cells switched to a new activity pattern that was entirely controlled by signals from the mouth. The activity of the PRLH neurons seems to affect how palatable the mice found the food.

This meant these cells are activated by the perception of taste. Hence there are other components of the appetite-control system that researchers need to think about.

Here, a PRLH-neuron-induced slowdown could be the solution. The taste of food triggers these neurons to switch their activity in seconds, from keeping tabs on the gut to responding to signals from the mouth.

The research appears in the journal Nature, titled “Sequential appetite suppression by oral and visceral feedback to the brainstem.”

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Staphylococcus species are very common members of the human skin microbiome. In terms of this, why do some people experience itchy sensations and not others? The answer may rest with the balance of the different microbial communities, where an ‘out of balance’ situation leads to those bacteria responsible for the itchy sensation moving into predominance.

Subsequent studies have shown how epicutaneous S. aureus exposure causes robust itch and scratch-induced damage.

Specifically, S. aureus can trigger a protein found on neurons that sends signals to the brain. This bacterium activates a biochemical pathway that leads us to want to scratch. When mice were exposed to these bacteria, they started to scratch, which got worse over several days. These mice also became very sensitive to stimuli that normally would not cause irritation or itch; these animals were itchy after only light touches, for example.

This appears to be the reason by S. aureus is found on almost every patient with the chronic condition atopic dermatitis.

Further study showed a bacterial enzyme called protease V8 is directly responsible for causing itch in mice. The V8 protease activates a protein called PAR1 on neurons that are found in the skin. These neurons carry sensory signals detected in the skin like touch, pain, and itch, to the brain.

PAR1 is usually inactive, but when it’s exposed to certain enzymes, including V8, ia portion of PAR1 is snipped off, activating the protein. This leads the brain to sense itch.

The researchers explored the hypothesis using a mouse model. This demonstrated that the activation of the PAR1 protein could be blocked by an anti-clotting medication. As a result, this drug halted itchiness.

The scientists are keen to assess if other microbes also trigger itch.

The research appears in the journal Cell. The paper is headed “S. aureus drives itch and scratch-induced skin damage through a V8 protease-PAR1 axis.”

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This is a natural extension of what happens during many routine medical visits, where physicians listen to sounds inside their patients’ bodies. This includes air moving in and out of the lungs, heart beats and even digested food progressing through the long gastrointestinal tract. These sounds provide valuable information about a person’s health.

Pilot studies undertaken by Northwestern University researchers have shown how these devices can accurately track the sounds associated with cardiorespiratory function, gastrointestinal activity, swallowing and respiration. The data comparison showed how the devices performed with clinical-grade accuracy.

A key advantage of the devices is the ability to simultaneously listen and compare different regions of the lungs. For example, by spatially mapping how air flows into, through and out of the lungs as well as how cardiac rhythm changes in varied resting and active states, and how food, gas and fluids move through the intestines.

These new wireless devices are designed sit softly onto the skin to continuously capture sounds (tracking all required sounds simultaneously and wirelessly), then stream data to smartphones or tablets in real time. The software that controls the devices can separate sounds within the body from ambient noise outside the body.

In terms of what the devices are composed of, each one contains miniaturised pairs of high-performance, digital microphones and accelerometers encapsulated within soft silicone. Each device also contains a flash memory drive, tiny battery, electronic components, Bluetooth capabilities and two tiny microphones — one facing inward toward the body and another facing outward toward the exterior. By capturing sounds in both directions, an algorithm can separate external (ambient or neighbouring organ) sounds and internal body sounds.

In one of the supporting studies, researchers tested the devices on adult patients, which included 35 adults with chronic lung diseases and 20 healthy controls. In all subjects, the devices captured the distribution of lung sounds and body motions at various locations simultaneously, enabling researchers to analyse a single breath across a range of regions throughout the lungs.

Where more than one device is used, the devices will interact to create a comprehensive non-invasive sensing network.

Outlining the potential importance of these devices, Northwestern’s John A. Rogers said: “Currently, there are no existing methods for continuously monitoring and spatially mapping body sounds at home or in hospital settings. Physicians have to put a conventional, or a digital, stethoscope on different parts of the chest and back to listen to the lungs in a point-by-point fashion. In close collaborations with our clinical teams, we set out to develop a new strategy for monitoring patients in real-time on a continuous basis and without encumbrances associated with rigid, wired, bulky technology.”

The research appears in the journal Nature Medicine, titled “Wireless broadband acousto-mechanical sensors as body area networks for continuous physiological monitoring.”

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