ChatGPT could help reduce vaccine hesitancy and provide helpful advice on STIs, suggests study

New research being presented at this year’s ESCMID Global Congress (formerly ECCMID) in Barcelona, Spain (27-30 April) suggests that the free-to-use, widely accessible ChatGPT could be an effective tool to help reduce vaccine hesitancy among the general public, as well as providing helpful advice on sexually transmitted infections (STIs) in conjunction with sexual health clinics, by improving knowledge and access to care.

“Our findings showed that ChatGPT displayed a remarkable ability to accurately respond to a wide breadth of commonly asked questions, encompassing topics such as misconceptions around mRNA vaccination and the importance of testing for STIs,” says lead author Dr Matthew Koh from the National University Health System (NUHS) in Singapore. “In the majority of instances, ChatGPT performed at the level of advice provided by professional organisations and guidelines.”

Since its unveiling in November 2022, millions of people have used AI (artificial intelligence) chatbots like ChatGPT for everything from making music to answering trivia to helping with homework. But ChatGPT has been mired in issues around its accuracy.

Vaccines have stopped epidemics and almost eradicated deadly diseases in the past such as polio, but vaccine hesitancy, directly linked to misinformation—false, inaccurate information promoted as factual—is on the rise, resulting in lower vaccine uptake. Since the public debut of ChatGPT, individuals with mistrust of health professionals may be using the technology to address their concerns.

Similarly, for individuals trying to access information on sexual health, or those worried about the stigma and embarrassment of attending a clinic, or with limited access to healthcare, could find using ChatGPT is a good way to get answers about STIs.

To find out more, researchers from the NUHS in Singapore tested ChatGPT to see whether it could successfully provide answers to common questions about vaccination and STIs.

A team of physicians who run infectious disease clinics asked ChatGPT to answer 15 commonly asked questions on vaccine hesitancy, including questions on doubts about the efficacy of vaccines, concerns about adverse effects, and cultural concerns relating to vaccines (see table in notes to editors).

They also asked ChatGPT 17 common questions on STIs based on general risk factors, access to care and diagnosis, and management and post-exposure prophylaxis (see table in notes to editors).

The AI-generated responses on vaccine hesitancy were then assessed by two independent infectious disease experts against recommendations from the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), and the chatbot answers on STIs were assessed against the 2021 US CDC STI Treatment Guidelines. All responses were evaluated for their completeness, quality, and accuracy.

Factual responses to vaccine hesitancy concerns

The researchers found that overall ChatGPT’s output provided factual responses and reassurance to vaccine hesitancy concerns.

For example, ChatGPT accurately highlighted the indication for measles vaccination in low incidence settings, and discussed the potential benefits of male human papillomavirus (HPV) vaccination. However, the AI chatbot failed to acknowledge the suggested ACIP age cut-offs for HPV vaccination, or account for a specific individual’s situation such as how sexually active they are.

In addition, ChatGPT provided reassurances for people with an egg allergy and influenza vaccination, and addressed misconceptions around mRNA vaccination and permanent alterations in DNA with high accuracy. However, it did not offer the non-mRNA vaccine options for COVID-19, but did encourage further discussions with healthcare professionals.

ChatGPT also appropriately acknowledged the complexity of religious issues around vaccination and directed individuals to have further discussions with religious leaders. Importantly, however, the researchers found that without specific details of the religious concern and the specific vaccine, ChatGPT’s advice was generic and it did not provide a more detailed risk-benefit discussion.

“Overall, ChatGPT’s responses to vaccine hesitancy were accurate and may help individuals who have vaccine-related misconceptions”, says Dr Koh, who is also an infectious diseases physician at the National University Hospital in Singapore. “Our results demonstrate the potential power of AI models to assist in public health campaigns and aid health professionals in reducing vaccine hesitancy.”

STI responses generally accurate and concise

The researchers also found that overall, ChatGPT’s responses on STIs were mostly accurate and concise.

For example, when asked about how to prevent STIs, the chatbot recommended safe sex practices HPV vaccinations as well as abstinence, but it failed to provide guidance on other key elements such as HIV pre-exposure prophylaxis.

In addition, the AI chatbot was able to provide general reassurance about STI symptoms, such as noting that other possibilities exist, and recommended going for testing. It also consistently communicated the importance of partner testing and follow-up testing.

However, when asked about chlamydia treatment, ChatGPT suggested either azithromycin or doxycycline, although the CDC favours doxycycline as the first-line treatment. It also failed to highlight the importance of testing for other STIs.

“ChatGPT provided good general advice about STIs, but it lacked specificity and could not tailor its advice to individual’s risk of acquiring STIs”, says Dr Koh. “The goal of this project is to empower the general public. The hope is that individuals can educate themselves with ChatGPT by making accurate advice more accessible and increase vaccine uptake and protection from STIs.”

He continues “We believe that ChatGPT should be used in conjunction with, or in addition to, a physician consultation—the human response is still needed to contextualise the advice that is given to a specific individual’s situation and for it to make the most sense and be the most helpful for the patient.”

ChatGPT could help reduce vaccine hesitancy and provide helpful advice on STIs ESCMID Global (ECCMID 2024

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AI system improves accuracy of CBCT images for implant placement, third molar extraction and orthognathic surgery: Study

AI system improves accuracy of CBCT images for implant placement, third molar extraction and orthognathic surgery suggests a new study published in the Journal of Dentistry.

A study was done to develop a deep learning-based system for precise, robust, and fully automated segmentation of the mandibular canal on cone beam computed tomography (CBCT) images. The system was developed on 536 CBCT scans (training set: 376, validation set: 80, testing set: 80) from one center and validated on an external dataset of 89 CBCT scans from 3 centers. Each scan was annotated using a multi-stage annotation method and refined by oral and maxillofacial radiologists. We proposed a three-step strategy for the mandibular canal segmentation: extraction of the region of interest based on 2D U-Net, global segmentation of the mandibular canal, and segmentation refinement based on 3D U-Net. Results: The system consistently achieved accurate mandibular canal segmentation in the internal set (Dice similarity coefficient [DSC], 0.952; intersection over union [IoU], 0.912; average symmetric surface distance [ASSD], 0.046 mm; 95% Hausdorff distance [HD95], 0.325 mm) and the external set (DSC, 0.960; IoU, 0.924; ASSD, 0.040 mm; HD95, 0.288 mm). These results demonstrated the potential clinical application of this AI system in facilitating clinical workflows related to mandibular canal localization. Accurate delineation of the mandibular canal on CBCT images is critical for implant placement, mandibular third molar extraction, and orthognathic surgery. This AI system enables accurate segmentation across different models, which could contribute to more efficient and precise dental automation systems.

Reference:

Fang-Duan Ni, Zi-Neng Xu, Mu-Qing Liu, Min-Juan Zhang, Shu Li, Hai-Long Bai, Peng Ding, Kai-Yuan Fu.Towards clinically applicable automated mandibular canal segmentation on CBCT, Journal of Dentistry, Volume 144, 2024, 104931, ISSN 0300-5712,

https://doi.org/10.1016/j.jdent.2024.104931.

(https://www.sciencedirect.com/science/article/pii/S0300571224001015)

Keywords:

Journal of Dentistry, AI system, improves, accuracy, CBCT images, implant placement, third molar extraction, orthognathic surgery, study, Fang-Duan Ni, Zi-Neng Xu, Mu-Qing Liu, Min-Juan Zhang, Shu Li, Hai-Long Bai, Peng Ding, Kai-Yuan Fu, Mandibular canal; Inferior alveolar nerve; Cone beam computed tomography; Deep learning; Convolutional neural networks

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First-in-human study demonstrates reduction of hard-to-reach ventricular tachycardias

 A new technology using ultralow temperature cryoablation (ULTC) has eliminated clinical ventricular tachycardia (VT) in 94% of patients. The late-breaking science is presented at EHRA 2024, a scientific congress of the European Society of Cardiology (ESC).

VT is a leading cause of sudden death in patients with heart failure and a reduced ejection fraction.2 Approximately 30% of patients with ischaemic and non-ischaemic cardiomyopathies develop ventricular arrhythmias including VT.3 Typical therapies to prevent VT include antiarrhythmic medication, such as amiodarone, and an implantable cardioverter-defibrillator (ICD).

Principal investigator Dr. Atul Verma of McGill University Health Centre, Montreal, Canada said: “Amiodarone suppresses VT but cannot eliminate it. In addition, the drug is associated with multiple serious side effects, which can lead to discontinuation in approximately 30-40% of patients.5 ICDs can successfully terminate VT with pacing or shocks, but the shocks are painful and are associated with increased mortality in the long-term. Ablation is an important option to eliminate VT but there have been no significant advancements in this therapy since the development of radiofrequency 15 to 20 years ago.”

Cryocure-VT was a first-in-human clinical trial evaluating the safety and efficacy of ULTC for the treatment of recurrent monomorphic VTs in patients with ischaemic and non-ischaemic cardiomyopathies. ULTC is a new energy source which produces very deep lesions in ventricular tissue and penetrates scar – essential qualities for successful VT ablation. Current technologies, like radiofrequency, achieve limited tissue depth and cannot penetrate scar tissue.

“The novelty of this trial is the design of the catheter, which can deliver ULTC (down to -180 C) and produce lesions of different tissue depth depending on the duration of the freeze,” said Dr. Verma. “By estimating tissue depth, either from preprocedural or intraprocedural imaging, the operator can choose which depth is required to treat the VT and deliver the required duration of ULTC. This was the first study to investigate whether the technology could work in patients.”

Cryocure-VT was a single arm study conducted at nine centres in Belgium, Canada, Czechia, France, Germany, and the Netherlands. The study included 64 patients with a history of VT, an indication for ablation, a history of ischaemic or non-ischaemic cardiomyopathy, and an ICD already implanted or planned for implantation immediately after ablation. The mean age of participants was 67 years and three (4.7%) were women. All patients underwent the ablation procedure using the ULTC catheter and the operator’s choice of electroanatomical mapping system.

The primary endpoints were acute non-inducibility of clinical VTs at the end of the procedure, freedom from major adverse events at 30 days, freedom from any sustained VT (>30 seconds) at six months, and freedom from ICD intervention at six months.

The primary acute effectiveness endpoint of non-inducibility of clinical VTs post-procedure occurred in 94% (n=51/54) of patients in whom post-ablation induction was attempted. All VTs were eliminated in 85% (n=46/54) of patients. There were no protocol-defined major adverse events at 30 days. There were four serious adverse events (6%), including one asymptomatic ventricular pseudoaneurysm, one small pericardial effusion which resolved without intervention, one small pericardial effusion which was drained, and one case of haemodynamic instability requiring extracorporeal membrane oxygenation (ECMO) support. One patient died of heart failure 26 weeks after the procedure.

At six months, 38 patients (60%; n=38/63) remained free of any sustained VT, and 51 patients (81%; n=51/63) remained free of ICD shocks.6 There were no significant differences between ischaemic and non-ischaemic cardiomyopathy patients.

Dr. Verma said: “ULTC ablation of monomorphic VT was effective and relatively safe in patients with ischaemic and non-ischaemic cardiomyopathies. The success rates for this novel procedure were at least as good, if not better, than prior VT radiofrequency ablation trials. The complication rates were consistent with other VT ablation trials. This technology is promising and may be an important advance for VT ablation by allowing the targeting of deeper mid-myocardial, and even epicardial, substrates. More studies, including randomised trials using this device in patients with monomorphic VT, are needed.” 

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Periostin shows promise to help fight a common form of esophageal cancer

Esophageal squamous cell carcinoma (ESCC) accounts for around 90% of esophageal cancers, especially in East Asia. New findings in The American Journal of Pathology, published by Elsevier, indicate that periostin, or POSTN, promotes ESCC progression by enhancing cancer and stromal cell migration in cancer-associated fibroblasts (CAFs). Therefore, it may be a novel therapeutic target for treating ESCC.

Lead investigator Yu-ichiro Koma, MD, PhD, Division of Pathology, Department of Pathology, Kobe University Graduate School of Medicine, explained, “Though CAFs in the tumor microenvironment are involved in the progression of various cancers, including ESCC, the underlying mechanisms are unclear. Therefore, it is critical to further investigate the mechanisms of esophageal cancer development and progression.”

To better understand the mechanisms of ESCC progression by CAFs, investigators generated CAF-like cells by directly coculturing human bone marrow–derived mesenchymal stem cells (MSCs) with ESCC cells, revealing elevated periostin expression. Recombinant human periostin activated the serine/threonine protein kinase (Akt) and extracellular signal-regulated kinase (Erk) signaling pathways in ESCC cells, which enhanced the survival and migration of these cancer cells. Periostin also enhanced MSC and macrophage migration and conferred tumor-associated macrophage (TAM)-like properties to macrophages. Immunohistochemistry demonstrated the clinical significance of periostin, associating its high expression with tumor invasiveness, vessel invasion, advanced pathological stage, CAF marker expression, and TAM infiltration. After direct coculture, ESCC cells showed increased characteristics of malignancy, such as tumor survival, growth, and migration, as well as increased phosphorylation of Akt and Erk.

Dr. Koma commented: “We discovered that periostin, up-regulated in CAFs upon direct contact with cancer cells, promotes ESCC progression and the migration of stromal cells like CAFs and TAMs. Periostin also enhanced mesenchymal stem cell and macrophage migration and endowed macrophages with tumor-associated macrophage-like properties. Thus, CAF-secreted periostin contributed to tumor microenvironment development.”

Dr. Koma concluded: “The present study established a direct coculture system between ESCC cells and MSCs, which promoted the malignant phenotype of ESCC cells. Patients with ESCC with high periostin expression exhibited poorer postoperative outcomes, indicating that periostin may be a novel therapeutic target for treating this form of esophageal cancer and may serve as a prognostic indicator.”

Esophageal cancer is the seventh most common cancer worldwide and the sixth leading cause of cancer-related death. The most common histological subtype is ESCC. The histologic types of esophageal cancer are broadly classified into ESCC and esophageal adenocarcinoma, with ESCC accounting for approximately 90% of esophageal cancers, especially in East Asia. In East Asia and East Africa, esophageal cancer is one of the top five causes of overall cancer mortality, and the five-year overall survival of ESCC is approximately 20%, with a poor prognosis. This prognosis is associated with a high propensity for metastasis, even if the tumor is superficial, Early esophageal cancer is often asymptomatic and diagnosis typically occurs at an advanced stage.

Reference:

Shoji Miyako, Yu-ichiro Koma, Takashi Nakanishi, Manabu Shigeoka, Yoshihiro Kakeji, Hiroshi Yokozaki, Periostin in Cancer-Associated Fibroblasts Promotes Esophageal Squamous Cell Carcinoma Progression by Enhancing Cancer and Stromal Cell Migration, American Journal Of Pathology, https://doi.org/10.1016/j.ajpath.2023.12.010.

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Seizure prophylaxis in mild and moderate TBI tied to reduced risk of early posttraumatic seizures: JAMA

USA: A recent meta-analysis including 8 studies has suggested a small, albeit significant, reduced risk for early posttraumatic seizures (PTS) for mild to moderate traumatic brain injury (TBI) of seizure prophylaxis.

The researchers suggest weighing the small absolute risk reduction against the risks of prescribing antiseizure medications. The findings were published online in JAMA Neurology on April 8, 2024.

“The absolute risk reduction of seizure prophylaxis for early PTS was 0.6% in mild and moderate traumatic brain injury,” the researchers reported. The overall rate of early posttraumatic seizures was low, ranging from 0% to 4%.

Traumatic brain injury is one of the leading causes of disability and death worldwide. Posttraumatic seizures contribute to secondary brain damage after TBI and are tied to increased hospital length of stay, mortality, and worse functional outcomes. Guidelines recommend seizure prophylaxis for early PTS after severe TBI. The use of antiseizure medications for early seizure prophylaxis after mild or moderate TBI remains controversial.

Against the above background, Matthew Pease, Indiana University School of Medicine, Indianapolis, and colleagues aimed to determine the association between seizure prophylaxis and risk reduction for early PTS in mild and moderate TBI.

For this purpose, the researchers systematically searched the online databases from 1991 to 2023. They included observational studies of adult patients presenting to trauma centers in high-income countries with mild (Glasgow Coma Scale [GCS], 13-15) and moderate (GCS, 9-12) TBI comparing rates of early posttraumatic seizures among patients with seizure prophylaxis with those without seizure prophylaxis.

The main outcome was absolute risk reduction of early PTS, defined as seizures within seven days of initial injury, in patients with mild or moderate TBI receiving seizure prophylaxis in the first week after injury. In patients with only mild TBI, a secondary analysis was performed.

Following were the key findings:

  • The researchers reviewed 64 full articles after screening; they included eight studies (including 5637 patients) for the mild and moderate TBI analysis and five studies (including 3803 patients) for the mild TBI analysis.
  • The absolute risk reduction of seizure prophylaxis for early PTS in mild to moderate TBI (GCS, 9-15) was 0.6%.
  • The absolute risk reduction for mild TBI alone was similar to 0.6%.
  • The number needed to treat to prevent 1 seizure was 167 patients.

The systematic review and meta-analysis of cohort studies indicate that seizure prophylaxis may effectively prevent early PTS for mild and moderate TBI, with an absolute risk reduction of 0.6%.

“Practitioners should weigh low prevalence of early PTS and low-risk reduction against risks of antiseizure medicine, including inappropriate long-term continuation,” the researchers wrote.

Reference:

Pease M, Mittal A, Merkaj S, et al. Early Seizure Prophylaxis in Mild and Moderate Traumatic Brain Injury: A Systematic Review and Meta-Analysis. JAMA Neurol. Published online April 08, 2024. doi:10.1001/jamaneurol.2024.0689

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Revascularization enhances quality of life for patients with chronic limb threatening ischemia: NEJM

Researchers have found in a new study that revascularization may restores sufficient blood flow back into the legs and  significantly improves quality of life among patients with chronic limb-threatening ischemia. The study has been published in the New England Journal of Medicine (NEJM).

Over 200 million people around the world  are suffering from fever peripheral artery disease (PAD) which is  a  condition caused by the narrowing of the blood vessels from the heart to the lower limbs.It  leads to pain when walking – and for roughly 1-in-10 this advances to chronic limb-threatening ischemia (CLTI).

Those with CLTI often suffer severe pain even at rest, caused by fatty plaque buildup obstructing blood flow, typically to the leg or foot. Those with CLTI face elevated risks of amputation, cardiovascular disease and premature death, yet research on the condition’s impact on quality of life remains limited.

Investigators from both of Mass General Brigham’s founding members, Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH), as well as Boston Medical Center (BMC), sought to address this problem. Following their previous study highlighting the clinical results of the BEST-CLI trial — Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia, the team assessed patient health-related quality of life before and after revascularization treatment. Results are published in Circulation.

“Our study indicates that patients with CLTI have a notably poor quality of life — substantially lower than with many other chronic conditions,” said Matthew Menard, MD, co-director of the Endovascular Surgery Program at BWH and co-principal investigator of BEST-CLI. “Our findings show that revascularization, which restores sufficient blood flow back into the legs, significantly improves quality of life. This confirms the critical role that revascularization plays not just in extending the length of patients’ lives but also its importance in optimizing their wellbeing.”

Among patients with CLTI, those eligible for surgical treatment often have two options: surgical bypass (Bypass), where surgeons restore blood and oxygen to the lower limb by reconstructing the blocked vessel, or endovascular therapy (Endo), which involves placing a stent or catheter inside an artery and opening it up to bring blood flow through a blockage.

Funded by the National Heart, Lung, and Blood Institute, with ongoing post-enrollment support from theNovo Nordisk Foundation, the BEST-CLI trial enrolled over 1,800 patients with CLTI from 150 research sites in the U.S., Canada, Finland, Italy, and New Zealand between August of 2014 and October of 2019. Investigators assessed how clinical outcomes (previously reported in NEJM) and quality of life metrics varied between revascularization techniques.

“Medicine is generally moving towards a more patient-centric model of care. That means looking at what’s best for each patient, taking into account an evidence-based approach. Quality of life is one important element in this determination,” said co-principal investigator Kenneth Rosenfield, MD, head of the Section of Vascular Medicine and Intervention in the Division of Cardiology at MGH.

Investigators sorted 1,528 participants into two cohorts. The first cohort was made up of 1,193 patients, all of whom had an available, good-quality, single-segment great saphenous vein (SSGSV), which previous studies have shown is optimal for Bypass. The second cohort was made up of 335 patients who did not have an available SSGSV. Patients in both cohorts were randomized to undergo Bypass or Endo procedures. Researchers assessed quality of life by administering voluntary surveys asking participants about pain levels, activities of daily living, disease symptoms and severity, physical activity, and mental health (anxiety and depression). Surveys were collected at baseline, 30 days post-procedure, at three months, 12 months, then once yearly until the end of the study.

“Patient-reported outcome measures are essential to our understanding of the patient experience,” said co-principal investigator Alik Farber, MD, MBA, interim chair of the Department of Surgery, chief of the Division of Vascular and Endovascular Surgery at BMC and professor of Surgery and Radiology at Boston University Chobanian & Avedisian School of Medicine. “Yet these metrics are not often used and sometimes ignored. Here we found an opportunity to hear our patients’ voices and use them to improve CLTI outcomes.”

While the trial’s previously published clinical outcomes revealed that patients treated with Bypass had fewer major amputations and less need for repeat procedures than those treated with Endo, quality of life did not significantly differ between treatments. Survey results instead revealed that participants generally experienced significant improvements in quality of life after treatment, regardless of their cohort or whether they underwent Bypass or Endo. They further highlighted that patients with CLTI overwhelmingly conveyed that their quality of life was low upon entering the trial, before receiving treatment.

This study is limited in that patients filled out quality-of-life questionnaires at distinct periods throughout the trial, but these time points did not necessarily line up with significant health events such as additional revascularization procedures or amputations. Further, there remains a dearth of quality-of-life research for patients with PAD, and there are no specific metrics to assess the quality of life for patients with PAD or CLTI.

Going forward, the team aims to assess differences in the cost-effectiveness of these procedures, and how cost, among other factors, affects patient quality of life and overall health outcomes.

“The next step is to integrate quality-of-life measures into a more sophisticated care plan to account for the clinical status of the patient and the cost-effectiveness of treatment options, both for the patient and the viability of the healthcare system,” said Farber.

Reference: Matthew T. Menard, Alik Farber, Richard J. Powell, Kenneth Rosenfield, Michael S. Conte, Taye H. Hamza, John A. Kaufman, Mark J. Cziraky, Mark A. Creager, Michael D. Dake, Michael R. Jaff, Diane Reid, George Sopko, Christopher J. White, Michael B. Strong, Max van Over, Emiliano Chisci, Philip P. Goodney, Bruce Gray, Ahmed Kayssi, Jeffrey J. Siracuse and Niteesh K. Choudhry and for the BEST-CLI Investigators Originally published10 Apr 2024https://doi.org/10.1161/CIRCULATIONAHA.123.065277Circulation. 2024;0

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CDSCO Panel grants AstraZeneca’s proposal for withdrawing specific Indications of Olaparib Tablets

New Delhi: Reviewing the Clinical evidence presented by drug major AstraZeneca, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the withdrawal of the indication of Olaparib 100mg and 150mg tablets in the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

This came after AstraZeneca presented the clinical evidence for the withdrawal of indication of AstraZeneca’s Olaparib 100mg and 150 mg tablets in the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Olaparib is a polyadenosine 5′-diphosphoribose polymerase (PARP) enzyme inhibitor. It works by killing cancer cells.

Olaparib is used alone or in combination with bevacizumab (Avastin) to help maintain the response of certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (the tube that transports eggs released by the ovaries to the uterus), and peritoneal (layer of tissue that lines the abdomen) cancer in people who have completely responded or partially responded to their first or later chemotherapy treatments. Olaparib is also used to treat certain types of breast cancer that have spread to other parts of the body and have not improved or have worsened after treatment with other therapies. It is also used to treat certain types of early breast cancer in people who have already been treated with surgery and other chemotherapy treatments.

Olaparib is also used to treat a certain type of prostate cancer that has spread to other parts of the body, no longer responds to medical or surgical treatments to lower testosterone levels, and has progressed after treatment with enzalutamide (Xtandi) or abiraterone (Yonsa, Zytiga). It is also used in combination with abiraterone and prednisone to treat a certain type of prostate cancer that has spread to other parts of the body and no longer responds to medical or surgical treatments to lower testosterone levels.

Olaparib is also used to help maintain the response of a certain type of pancreatic cancer that has not spread or progressed after the first chemotherapy treatment.

At the recent SEC meeting for Oncology held on 19th & 20th March 2024, the expert panel reviewed the proposal presented by drug major AstraZeneca for the withdrawal of indication of the drug Olaparib 100mg and 150mg tablets in the treatment of the patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

After detailed deliberation, the Subject Expert Committee has agreed to withdrawal the same indication.

Also Read: Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

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Roche gets USFDA Breakthrough Device Designation for blood test to support earlier Alzheimer’s disease diagnosis

Basel: Roche has announced that its Elecsys pTau217 assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

This blood test, which is being developed in collaboration with Eli Lilly and Company, will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies. If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer’s disease on people and society.

“The incidence of dementia is growing worldwide, with 75 percent of cases remaining undiagnosed. Consequently, there is a critical role for Diagnostics to play in addressing this global health challenge,” said Matt Sause, CEO of Roche Diagnostics. “We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease, a condition where Roche Diagnostics is committed to improving the lives of patients worldwide. We plan to leverage our installed base of diagnostic systems, which is the largest in the world, to ensure we are able to create access to this test for those who need it the most.”

“The development of the Elecsys pTau217 plasma assay is another milestone in our collaboration with Roche Diagnostics that will advance the Alzheimer’s diagnostic ecosystem,” said Anne White, executive vice president of Eli Lilly and Company, and president of Lilly Neuroscience. “We’re excited to help meet the growing need for additional diagnostic tools to enable a timely and accurate diagnosis for people with Alzheimer’s disease.”

pTau217, which is a phosphorylated fragment of the protein tau, is a biomarker that has shown the ability in research settings to distinguish Alzheimer’s disease from other neurodegenerative disorders and has shown strong performance relative to other biomarkers.

Elecsys Phospho-Tau (217P) is intended to be an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) (pTau217) in human plasma from individuals aged 60 years and older. The test is intended for use as an aid in identifying amyloid pathology, a pathological feature of Alzheimer’s disease.

A positive Elecsys pTau217 result indicates a high likelihood of having a positive amyloid PET/CSF result.

A negative Elecsys pTau217 result indicates a high likelihood of having a negative amyloid PET/ CSF result.

An indeterminate pTau217 result indicates uncertainty on the amyloid PET/CSF result.

The pTau217 result should be used in the diagnostic pathway in conjunction with other clinical information.

Today, the company’s Alzheimer’s portfolio spans investigational medicines for different targets, types and stages of the disease. This includes trontinemab, an innovative Brainshuttle anti-amyloid treatment that is specifically engineered to cross the blood-brain barrier. On the diagnostics side, it also includes approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor the disease. 

The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.

Read also: Roche Diagnostics India launches point-of-care NT-proBNP test for screening diabetes patients at cardiovascular diseases risk

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Kerala HC grants interim relief to doctor accused of abetting his former fiance’s suicide

Granting interim relief to the doctor accused of abetting his former fiance’s suicide, the Kerala High Court has allowed him to rejoin his post-graduate studies.

This order was passed by a single-judge bench consisting of Justice Ziyad Rahman AA after considering the ‘irreversible damage’ caused by preventing the accused doctor from attending classes, Live Law has reported.

For more information, click on the link below:

Kerala PG Medico Suicide Case: HC Grants Interim Relief To Accused Doctor, Allows To Rejoin MS Orthopaedics Course



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DGHS defends broader definition of Intensivist, Critical Care Specialists see red

Although the Directorate General of Health Services (DGHS) under the Union Health Ministry recently defended its broader definition of an “Intensivist” citing the scarcity of physician staff with minimum standards of training for critical care delivery, the critical care specialists having NMC recognised degrees are not happy with the explanation.

Raising the issue, a newly formed Forum of Intensivists and Critical Care Specialists (FICCS) agreed that the need for critical care specialists in resource-limited settings is a matter of concern and “possibly DGHS have given a uniform all-inclusive definition of intensivists to match the demand.”

For more information, click on the link below:

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