What happened in health care technology this week – and why it’s important.
UK firm to trial T-cell Covid vaccine that could give longer immunity
An Oxfordshire-based company will soon start clinical trials of a second-generation vaccine against Covid-19. This easy-to-administer skin patch uses T-cells to kill infected cells and could offer longer-lasting immunity than current vaccines. As reported by Julia Kollewe in The Guardian, Emergex has received the green light from the Swiss drugs regulator to conduct initial human trials in Lausanne, involving 26 people who will receive a high and a low dose of its experimental Covid-19 vaccine, starting on 3 January. Interim results from the trial are expected in June.
Why it’s important – A study published in Nature last week showed that some people experience “abortive infection” in which the virus enters the body but is cleared by the immune system’s T-cells at the earliest stage. Scientists said the discovery could pave the way for a new generation of vaccines targeting the T-cell response, producing much longer-lasting immunity. And the technology has broader applications than just COVID-19. Emergex is testing another T-cell vaccine against dengue fever on humans in a separate Swiss trial, with initial results due in January.
Hilton is Amazon Care’s newest client
Amazon Care will be providing health services to Hilton as its second publicly announced customer. As reported by Reuters, all of Hilton’s staff in the United States who are enrolled in a corporate health plan will have access to Amazon’s app-based medical options starting next year. The deal with Hilton Worldwide Holdings Inc, which Reuters is the first to report, marks Amazon Care’s first hospitality customer and only its second disclosed client after fitness equipment maker Precor.
Why it’s important – It shows how the company is seeking to disrupt the healthcare industry with a tried-and-true playbook. Just as Amazon built data centers to satisfy its e-commerce needs and later sold access to this infrastructure in what became its cloud-computing business, so is Amazon looking to market a healthcare service it built first for its workers’ benefit. So, don’t write off Amazon as a major player in health care services just yet.
FDA clears GE Healthcare AI algorithm for patient intubation
An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA. As reported in Pharmaforum online, the new tool – part of GE’s Critical Care Suite 2.0 – helps bedside staff and radiologists assess patients before intubation – for example, before ventilation in patients with critical COVID-19 – and make sure their ETTs are positioned correctly.
Why it’s important – Anyone who has intubated a patient or at least witnessed the intubation process knows how tricky it can be even in the hands of an experienced medical professional. Using the AI, ETTs are automatically identified in chest X-ray images, providing feedback to the clinician on positioning within seconds and warning them if it hasn’t been placed correctly. It will also quickly detect complications like pneumothorax and can automatically send an alert to a radiologist along with the X-ray images for review.
Smartphone-powered trial backs J&J’s Invokana for heart failure
In what is being labeled as one of the first “virtual clinical trials,” Pharmaforum online reports that Johnson & Johnson’s SGLT2 inhibitor Invokana has been shown to have a significant effect on heart failure symptoms in a clinical trial that relied entirely on remote monitoring of symptoms using a smartphone app.
“We did not know if a completely ‘virtual’ clinical trial, especially one where randomised treatment was delivered to participants and the outcomes were collected through a smartphone app, could work.”
John Spertus, Lead University of Missouri-Kansas City School of Medicine
Why it’s important – Demonstrating the success of a decentralized clinical trial opens opportunities for applying this approach to the testing of other cardiovascular therapies that focus on health status. This study also proves that virtual clinical trials can be effectively used across a broad spectrum of life sciences developments.
VR treatment for chronic pain gets FDA authorization
Nicole Wetsman’s article in The Verge highlights the FDA clearance of a virtual reality system as a prescription treatment for chronic back pain. The therapy, called EaseVRx, joins the shortlist of digital therapeutics cleared by the agency over the past few years. EaseVRx includes a VR headset and a device that amplifies the sound of the user’s breath to assist in breathing exercises. It uses principles from cognitive behavior therapy, which aims to help people recognize and understand various thought patterns and emotions. The program addresses pain through relaxation, distraction, and improved awareness of internal signals, the FDA said in its statement.
Why it’s important – Around two-thirds of participants using EaseVRx said they had more than 30 percent reduction in pain, while only 41 percent of the control group had a similar decline. The reduced pain lasted for up to three months after the study for people in the EaseVRx group but not for the control group. The VR system could be an alternative option to opioid medications for back pain. For a deeper dive into the use of extended reality in health care, check out my earlier post on the topic here.
CMS proposes expanded payment for CT lung cancer screening
Kate Madden Yee reported on the news that the U.S. Centers for Medicare and Medicaid Services (CMS) on November 17 released a proposed update to its low-dose CT lung cancer screening guideline that would start paying for exams beginning at age 50 five years younger than under its current policy. The move would bring Medicare and Medicaid reimbursement in line with recommendations from the U.S. Preventive Services Task Force (USPSTF), which itself lowered its recommended starting age for screening earlier this year.
Why it’s important – The action is an acknowledgment of the severity of lung cancer and its high mortality rates if it is not caught and treated early — which is of particular importance in the older Medicare population. “Lung cancer is the third most common cancer and the leading cause of cancer-related death in both men and women in the United States,” the agency wrote. “It is an important issue for the Medicare population due to the age at diagnosis and the age at death. In 2021, the National Cancer Institute (NCI) estimated that the number of new cases is over 235,000, with a median age at diagnosis of 71 years.” Like the USPSTF guidance released in March, the proposed guidance from CMS lowers the starting age for screening from age 55 to age 50 and the smoking history from 30 pack years to 20.
First human trial of Alzheimer’s disease nasal vaccine to begin at Boston hospital
Brigham and Women’s Hospital will test the safety and efficacy of a nasal vaccine to prevent and slow Alzheimer’s disease, the Boston hospital announced Tuesday. The start of the small, Phase I clinical trial comes after nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at the hospital. The trial will include 16 participants between the ages of 60 and 85, all with early symptomatic Alzheimer’s but otherwise generally healthy. They will receive two doses of the vaccine one week apart, the hospital said in a press release. The participants will enroll at the Ann Romney Center.
Why it’s important – If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s. It could also be given early to help prevent Alzheimer’s in people at risk. Research in this area has paved the way for researchers to pursue a whole new avenue for potentially treating AD and other neurodegenerative diseases.