<p>Welcome to the November healthcare news roundup, where we provide information on the latest developments in treatments, devices, and technologies in the medical field.</p>
<p>This month, we will focus on the effects of COVID-19 on the brain, what new information is available for a recent drug to treat Alzheimer’s disease, and how researchers are using light to manipulate neurons. We will also explore what are the cybersecurity threats for medical devices, the risks and benefits of new virtual reality medical devices, and how gut bacteria influences the risk of depression.</p>
<h2>Brains of People Who Had COVID-19 Resemble Those of Old People</h2>
<p id="E109">There are now a number of scientific articles linking SARS-CoV-2 infection to both cognitive decline and a phenomenon called “brain fog,” in which patients report difficulties concentrating, thinking, and remembering things. Following one of the first reports of cognitive decline associated with COVID-19, Maria Mavrikaki, a neurobiologist at the Beth Israel Deaconess Medical Center in Boston, Massachusetts, decided to investigate if there were structural changes in the COVID-affected brains that might explain the cognitive effects.</p>
<p id="E117">She and her team found that <a is="qowt-hyperlink" href="https://www.nature.com/articles/d41586-022-04253-8" target="_blank" rel="noreferrer noopener">COVID-19 changed the brains of patients</a> just like old age would change them. The findings open a series of other questions relating to cognition and COVID-19, with potential consequences for society in the future. In their study, the researchers studied brain samples of 21 people who had severe COVID-19 when they died and one person with an asymptomatic SARS-CoV-2 infection at death. The team then compared these samples with those from 22 people without a history of SARS-CoV-2 infection. The team found that the brains of people that suffered from severe COVID-19 had more activity in genes related with inflammation and stress, and less activity in genes responsible for making connections between brain cells. This pattern of gene activity is similar to that of older people.</p>
<p id="E128">This work is setting the stage for further research, in which the role of brain inflammation will be explored in more detail, as well as the brain changes caused by milder COVID-19. The researchers are also keen to know if the brain changes caused by SARS-CoV-2 infection are permanent or if they can be reverted with time.</p>
<h2>More Information on New Alzheimer Drug—Will It Be Enough to Convince Experts?</h2>
<p id="E150">On our <a is="qowt-hyperlink" href="https://www.trueprofile.io/member/resources/october-healthcare-news" target="_blank" rel="noreferrer noopener">October Healthcare News Roundup</a>, we highlighted the positive results of lecanemab in a clinical trial that included patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia and confirmed amyloid accumulation in the brain. Lecanemab is an antibody that attaches to a protein called amyloid beta, signaling it for destruction and removal from the brain. These amyloid lumps are toxic to the brain, interrupting communication between brain cells.</p>
<p id="E155">The approval of other Alzheimer drug which targets beta-amyloid plaques, aducanumab, has been quite controversial, dividing experts on issues like clinically meaningful benefit for patients and safety. This shadow has followed lecanemab, which, although targeting a different form of amyloid, faces the same scrutiny regarding meaningful benefits for patients versus risk. However, there are some differences between the two drugs, which may tilt the scale in favor of lenanemab.</p>
<p id="E160">The data from lecanemab’s clinical trial is already available, allowing <a is="qowt-hyperlink" href="https://www.biopharmadive.com/news/lecanemab-alzheimers-eisai-biogen-full-study-results-ctad/637568/" target="_blank" rel="noreferrer noopener">experts to analyze the results</a> while the drug is being evaluated by the United States Food and Drug Administration (US FDA). The results of the clinical trial were published in the New England Journal of Medicine, showing that the drug was indeed able to reduce the accumulation of beta-amyloid in the brain in patients who were taking the drug versus those who were taking placebo. In addition, the authors of the study described that lecanemab-treated patients had lower levels of markers linked to brain cells degradation and inflammation than placebo-treated patients.</p>
<p id="E169">But the real question for clinicians and patients is how these changes in the brain translate to a meaningful effect on Alzheimer’s progression. According to the trial results, there was a half-point decline in the 18-point rating scale known as the Clinical Dementia Rating – Sum of Boxes (CDR-SB), which is widely used to measure dementia stages. For some experts, the small difference seen with lecanemab is meaningful, especially if it is progressive, while others would like to see at least a 1- or 2-points difference on that scale to be considered clinically meaningful. This effect has also to be considered in the light of the adverse effects: in this trial, there were some patients who had brain swelling and/or hemorrhages, some of which might be related to the drug.</p>
<p id="E172">The risks and benefits of lecanemab are being evaluated by the FDA, and a decision is expected in early 2023.</p>
<h2>Using Light to Manipulate How Neurons React to Stimulations</h2>
<p id="E188">Optogenetics is a technique to control a neuron’s activity using light and genetic engineering. It has been used since its development nearly 20 years ago, but so far, the researchers could only induce real-time changes, meaning they had to be constantly illuminating the cells. This limited the applicability of this technique outside the lab.</p>
<p id="E191">Now, researchers from the Massachusetts Institute of Technology and Harvard University found a way to <a is="qowt-hyperlink" href="https://news.mit.edu/2022/neuron-excitability-optogenetics-1207" target="_blank" rel="noreferrer noopener">use optogenetics in a longer-lasting way</a>. With their new strategy, they can use light exposure to change the electrical capacitance of the neurons’ membranes, which alters their excitability (how strongly or weakly they respond to electrical and physiological signals). The capacitance of the cell membrane is a key element for its ability to conduct electricity: when the capacitance is increased, neurons are less reactive to stimuli from other cells, and when the capacitance is decreased, neurons become more excitable, reacting faster to stimuli.</p>
<p id="E197">The team of researchers showed how they were able to change neurons’ capacitance by inducing them to assemble either conductive or insulating polymers in their membranes. They genetically engineered the neurons with a light-sensitive protein. When exposed to blue light, the protein will produce highly reactive molecules. These molecules then spur the formation of conductive or insulating polymers in the neuron’s membrane, thus altering its capacitance.</p>
<p id="E200">The changes lasted for three days, which is as long as they could keep the neurons alive in their lab dish. The researchers are now working on adapting the technique so that it can be used in animal studies, which is the next step in understanding how changes in neuron excitability can affect diseases like multiple sclerosis and Alzheimer.</p>
<p id="E207">“In the near future, we’re using it more as a model to investigate those diseases, but you could imagine potential therapeutic applications,” says Wenbo Wang, one of the lead authors of the study.</p>
<h2>Cybersecurity Risks in Medical Devices</h2>
<p id="E217">Developing more sophisticated cybersecurity programs should be a priority for all medical devices’ companies, since attacks are on the rise and patient care could be compromised, according to an article published in the <a is="qowt-hyperlink" href="https://www.medicaldevice-network.com/features/plenty-of-phish-medical-device-manufacturers-urged-to-assess-cybersecurity-risk-and-readiness/" target="_blank" rel="noreferrer noopener">Medical Device Network</a>. Nowadays, there are more medical device products connected to technologies such as cloud-based data storage and capabilities, which increase the opportunities for hackers to attack them. Devices such as insulin pumps, heart pacemakers, inhalers, and wearables are particularly vulnerable as they track patient data in real-time and transmit information immediately to the patient and/or their doctor.</p>
<p id="E217">In addition, there are many medical devices still in use that are considered legacy devices, for which there are no available security patches and updates, placing them at a higher risk of ransomware attacks. Such devices were not built with security in mind, which leads them to be more vulnerable.</p>
<p id="E227">Taking into account that health data are the most commonly breached data type, there should be an effort to combat this security risk, the experts say. As the cyber landscape continues to evolve, there should be a shift in focus from incident management, where the effort in is mitigating the outcomes of an attack, to a prioritization of risk management. This means that manufacturers must assume that the software they use on their medical devices will at some point face vulnerabilities, and prepare for it in the early stages of the design.</p>
<p id="E234">To reduce risks, the <a is="qowt-hyperlink" href="https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity" target="_blank" rel="noreferrer noopener">FDA has a page</a> with resources for healthcare organizations, in which they emphasize the need for preparedness and response for medical device cybersecurity issues.</p>
<p id="E239">By developing devices that can receive security updates, there is less opportunity for these to be used as an entry point to healthcare systems, thus limiting hackers’ ability to infiltrate networks, access data, disrupt care, and extract money.</p>
<h2>Risks and Benefits of Augmented Reality and Virtual Reality in Medical Devices</h2>
<p id="E258">Augmented reality and virtual reality (AR/VR) are changing the way healthcare is delivered, says the FDA, whose non-exhaustive list of medical devices incorporating the technology features 39 products across different therapeutic areas. The agency sees <a is="qowt-hyperlink" href="https://www.medtechdive.com/news/FDA-AR-VR-benefits-risks-home-care-medtech/638278/" target="_blank" rel="noreferrer noopener">benefits in these technologies, but also some risks</a>.</p>
<p id="E267">Some examples of AR/VR already in use include the use of AR to overlay medical images onto a patient during an operation to guide the surgeon and the use of VR to help treat psychiatric or physical conditions.</p>
<p id="E269">Among the benefits of using AR/VR are the increased access to healthcare, by provide remote options of diagnosis and treatment to people who may have difficulties in going to in-person appointments, such as the socioeconomically vulnerable, the elderly, and/or disabled people. The FDA also recognizes that the use of an AR/VR device may introduce new benefits and fulfil unmet medical needs.</p>
<p id="E280">One of the risks associated with the use of AR/VR devices is cybersickness, a disorder like motion sickness, where the brain receives information that the body is moving when it is not, leading to nausea, oculomotor issues, and general disorientation. The use of these devices, usually goggles, can also cause head and neck strain. Cybersecurity, privacy issues, and distraction in the operating room are also mentioned by the FDA as possible risks of these devices.</p>
<h2>Gut Bacteria Influences Depression</h2>
<p id="E290">Although affecting the brain, there is new evidence that <a is="qowt-hyperlink" href="https://www.doctorslounge.com/index.php/news/hd/112683" target="_blank" rel="noreferrer noopener">depression is influenced by the microbiome</a>, which is composed by a wide collection of microorganisms living on and in the human body. The microbiome is necessary for physical functioning, since it produces essential nutrients and protective elements against pathogens.</p>
<p id="E300">The role of microbiome in depression has been recently clarified by two extensive studies involving more than 5,500 Dutch adults. The researchers found that a microbiome containing less diverse bacteria, or in which certain bacterial species are underrepresented, was associated with having depression or more depressive symptoms. In particular, there were 13 groups of bacteria that were related to the odds of adults having depression symptoms, either by being depleted or by existing in large numbers. The association between these bacteria and depression was as strong as established risk factors for depression such as smoking, alcohol consumption, a lack of exercise and being overweight.</p>
<p id="E313">The major implication of this research is that influencing the microbiome may be highly relevant in the treatment of depression. However, it is still too soon to advocate for the use of probiotics to prevent depression, since the studies did not prove that the bacteria were responsible for the depressive symptoms exhibited by the participants, only that their levels were altered.</p>
<p id="E316">Either way, the relationship between gut bacteria and depression may be relevant not only for future treatments but also for diagnosis. Currently, there is no objective measurement to diagnose depression, but this study may help to develop a biomarker for the condition, the authors noted.</p>
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