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Earlier this year, the Drug Enforcement Agency (DEA) announced that it would move marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA), greatly reducing the restrictions on the drug. It represents a historic change in federal marijuana policy and a watershed moment for generations of activists that have sought legalization on a national level. While many advocates believe the shift bodes well for efforts to relax controls on other Schedule I drugs—including promising psychedelics like psilocybin, MDMA, and LSD– Vanderbilt Law professor Robert Mikos argues that the marijuana rescheduling decision will not pave the way for rescheduling any other drug. Mikos explains that the decision preserves the barriers that make it virtually impossible to remove drugs from Schedule I. He labels those barriers the “tyrannies of scheduling.” In his paper “Marijuana and the Tyrannies of Scheduling,” forthcoming in Fordham Law Review, Mikos lays out the core challenges posed by the existing scheduling process and offers a solution that would lead to “more rational scheduling decisions that better reflect the benefits and dangers of controlled substances, as Congress intended.” The Role of Currently Accepted Medical Use in Scheduling Decisions The CSA creates five Schedules (I-V). Scheduling dictates how a drug is regulated under the statute. Schedule I drugs are subject to the most restrictive controls, and those controls are steadily relaxed as one moves down the schedules. Congress made all the initial scheduling decisions when it passed the CSA in 1970, but it also empowered the DEA, working in conjunction with the Department of Health and Human Services (HHS), to reschedule drugs based on new information acquired after the passage of the statute. Agency scheduling decisions are supposed to be based on three core characteristics of a drug: its abuse potential, its dependence liability, and whether it has a currently accepted medical use (CAMU). Unfortunately, these characteristics do not always suggest the same schedule for a drug. But as Mikos explains, the DEA has grossly simplified the scheduling process by suggesting that CAMU determinations should trump all other considerations. In particular, the agency has insisted that a drug with no CAMU must be placed on Schedule I, regardless of its abuse potential or dependence liability. According to Mikos, the DEA’s simplification of the scheduling process places tremendous weight on agency CAMU determinations and how the agency chooses to define this particular scheduling criteria. The Tyranny of Science In the past, the DEA insisted that the only way to demonstrate that a drug has a CAMU was by completing multiple controlled trials (RCTs) demonstrating that a drug is effective at treating some medical indication, the same requirement for new drug approval under the Food, Drug and Cosmetic Act. As Mikos has noted in his past work, completing such trials is “notoriously expensive and time-consuming,” requiring strict parameters and a large number of participants. The challenge is even more daunting for drugs already on Schedule I, because the CSA restricts research on such drugs. Due to regulatory restrictions, marijuana advocates have struggled to complete even a single RCT demonstrating marijuana’s medical efficacy. Indeed, in the past 50 years, only one Schedule I drug (Epidiolex) has ever been able to satisfy the DEA’s CAMU test, leading Mikos to label the agency’s science-focused approach the “Tyranny of Science.” The Tyranny of the Majority In 2023, however, HHS devised an alternative CAMU test that emphasizes practical experience over scientific research. “Because more than 30,000 health care practitioners (HCPs) had already recommended the drug to their patients in the thirty-eight states with medical marijuana laws,” Mikos explains, “the agency concluded there was enough clinical experience to demonstrate that marijuana has a CAMU and thus could be rescheduled.” But while this alternative test does not require completing RCTs – and thereby eliminates the Tyranny of Science – Mikos demonstrates that it is no less tyrannical than the DEA’s original CAMU test. According to Mikos, the alternative CAMU test simply “imposes a different form of tyranny: the Tyranny of the Majority.” He explains that to accumulate the clinical experience needed to satisfy the new test, advocates must convince popular majorities in a substantial number of states to legalize medical use of a drug. It took decades to build the public support necessary to do that for marijuana, and Mikos points out that no other Schedule I drug currently commands the same level of public support as marijuana. “Despite growing interest in the therapeutic value of [psychedelics, . . . less than a quarter of all Americans support legalizing psychedelics like psilocybin,” Mikos writes. “By comparison, 90% of Americans support legalizing medical marijuana.” What is more, even if large numbers of states were to legalize medical use of a substance like psilocybin or MDMA, advocates will also have to convince large numbers of patients, their health care practitioners (HCPs), and their suppliers to risk federal sanctions in order to accumulate the clinical experience HHS demands to satisfy the new CAMU test. “While marijuana was finally able to run the gauntlet, no other Schedule I is likely to replicate that feat anytime soon. Other promising Schedule I drugs like psilocybin, MDMA, and LSD are likely to remain trapped on that schedule for the foreseeable future,” the paper states. A New Way Forward Mikos argues that the agencies did not need to create a new CAMU test to reschedule marijuana. He suggests that the DEA has placed too much emphasis on CAMU in scheduling decisions. The DEA “has no authority, and no good reason, to hold (or place) a drug on Schedule I solely because the drug lacks a currently accepted medical use.” Indeed, Mikos suggests the agency’s emphasis on CAMU runs contrary to the text of the CSA and provides insufficient information about a drug’s benefits and risks to make sensible scheduling decisions. Rather than propose yet another, less tyrannical CAMU test, Mikos suggests that the DEA should instead take a more flexible approach to scheduling, one that considers all 3 criteria – a drug’s abuse potential, its dependence liability, and whether or not it has a currently accepted medical use (CAMU)—to determine where a drug belongs among the statute’s five schedules. “Although my approach would not make it any easier to demonstrate CAMU, it would reduce the dominant influence CAMU determinations now wield over scheduling decisions,” Mikos concludes. It would enable the agency to remove drugs like marijuana, psilocybin, or MDMA from Schedule I, even if they lack a currently accepted medical use, if their abuse potential and dependence liability so warrant. “As a result,” he notes, “my approach would foster more rational administrative scheduling decisions going forward.”
For the fifth consecutive year, ChristianaCare’s Center for Heart & Vascular Health has earned the premier recognition from The American College of Cardiology (ACC) – the HeartCARE Center National Distinction of Excellence award – for its commitment to comprehensive, high quality cardiovascular care. ChristianaCare was the first hospital system in Delaware and one of only a handful in the U.S. to attain this recognition when it was first awarded in 2020 from the ACC, a nonprofit medical association representing more than 50,000 cardiovascular specialists. “We are proud to be a regional leader for cardiovascular care with the most advanced medical, surgical and minimally invasive specialty care, technology and research,” said Kirk Garratt, M.D., medical director of ChristianaCare’s Center for Heart & Vascular Health. “Congratulations to our entire team and all who collaborate seamlessly to deliver care 24/7. As a result, those living in Delaware and neighboring states can receive the highest quality cardiovascular care from the Center for Heart & Vascular Health.” Hospitals that have earned an ACC HeartCARE Center designation have met a set of criteria, including participating in at least two ACC accreditation services programs, national cardiovascular data registries and targeted quality improvement campaigns designed to close gaps in guideline-based care. In addition to being a current recipient of the HeartCARE Center designation, ChristianaCare participates in the ACC’s chest pain MI with PCI (heart attack with angioplasty) and resuscitation accreditation, cath lab accreditation and the Society of Thoracic Surgeon database. “ChristianaCare has demonstrated its commitment to providing the community with excellent heart care,” said Deepak L. Bhatt, M.D., MPH, FACC, chair of the ACC accreditation management board. “ACC accreditation services is proud to award the Center for Heart & Vascular Health with the HeartCARE Center designation.” Hospitals receiving the HeartCARE Center designation have demonstrated their commitment to consistent, high-quality cardiovascular care through comprehensive process improvement, disease and procedure-specific accreditation, professional excellence and community engagement. ChristianaCare has proven to be a forward-thinking institution with goals to advance the cause of sustainable quality improvement. The Center for Heart & Vascular Health is among the largest, most capable regional heart centers on the East Coast. It is among the few centers in the region that integrates cardiac surgery, vascular surgery, vascular interventional radiology, cardiology and interventional nephrology in a single location. Its expert clinical staff performed nearly 200,000 patient procedures last year.
Saving Lives, One Device at a Time: Clinical Engineering
Behind every health care provider, or perhaps already in the palms of their hands, is a piece of equipment necessary to their patient’s health and survival. Modern medical treatment relies on complex equipment to keep patients alive and healthy during procedures and recovery. Take live-saving equipment such as telemetry monitors, MRI machines and ventilators as just a few examples. But what happens when all that equipment needs repair? Enter ChristianaCare’s clinical engineering technicians. This team of 35 employees — one of the largest clinical engineering teams in the nation — is responsible for overseeing the care, testing and repair of the roughly 50,000 pieces of medical equipment in use throughout the ChristianaCare system. The Clinical Engineering team is overseen by Director Blake Collins, MBA, CBET, CHTM, nationally recognized for excellence in the profession. He brings two decades of experience as a clinical engineer in the United States Navy, seven of which were served with the U.S. Marine Corps, to his role. His team has won numerous trade industry awards for its success as a “solutions provider” for the health system. "Think of health care as a triangle,” said Collins. “You have the patient, the provider and the equipment. You can’t have successful health care delivery without those three elements.” Begun in the 1970s as the hospital system’s “TV repair shop,” he joked, the Clinical Engineering department evolved dramatically after subsequent national developments in electrical safety testing and oversight for the care and functionality of medical equipment. ‘Everyone truly cares’ Today, the Clinical Engineering department maintains close to 50,000 pieces of medical equipment throughout the ChristianaCare system, including its three hospitals and all its imaging centers. “From thermometers to linear accelerators, MRIs, CTs — we manage all of it,” Collins said. Last year, the team completed 25,000 work orders, or roughly 2,100 per month. “We get to help people in so many different ways,” said John Learish, Clinical Engineering manager. Samantha Daws, Clinical Engineering supervisor, echoed the sentiment. “The Clinical Engineering Department within ChristianaCare is the most talented group of technicians I have ever had the privilege to work with,” she said. “Everyone truly cares about keeping the equipment working to ensure all caregivers have what is needed to provide quality health care to our community.” Saving lives, one device at a time What’s so important about what Clinical Engineering offers to ChristianaCare? In short: Anyone could need medical care at any time, and if medical equipment were out of commission or wrongly calibrated, lives would be at stake. Collins recalls a pivotal moment during his tenure in the Navy, when he needed an emergency appendectomy while stationed on board an aircraft carrier. “I was the only biomedical technician on the ship,” he said. “And the doctor doing the procedure asked me, jokingly, ‘Hey Collins, is this equipment going to work?’ “He was kidding, but it’s true that we never know when we or a loved one is going to end up under the equipment that we work on as engineers.” This experience gained new significance for Collins after successful open-heart surgery at ChristianaCare in 2022 — followed by his mother, who had the same procedure, also successfully, in 2023. “I had not one inkling or shadow of a doubt that the equipment was going to work fine,” he said. “You never know who will end up needing care. So we take it very, very seriously.” Icon in the field For his outstanding service as Director of Clinical Engineering at ChristianaCare, Collins was presented with the 2024 John D. Hughes Iconoclast Award from the Association for the Advancement of Medical Instrumentation (AAMI), a career-marking honor in health care technology management. The award recognizes innovation and leadership in the field; for Collins, it shows how well the Clinical Engineering team works together to deliver safe medical equipment across the ChristianaCare system. “Blake has been a relentless advocate for ChristianaCare,” read his nomination. “He has implemented numerous initiatives and processes to improve his department … and work smarter through the use of technology and automation.” The next time you see a ChristianaCare provider pick up an instrument or turn on a machine, think about the Clinical Engineering team — and rest assured that your equipment is ready to go.
Stephen Pearlman, M.D., Honored for Excellence in Neonatology Education
Stephen Pearlman, M.D., MSHQS, will receive the 2024 Avroy Fanaroff Neonatal Education Award at the American Academy of Pediatrics’ annual meeting in September. This honor, presented by the AAP’s section on Neonatal-Perinatal Medicine, recognizes an educator who makes outstanding contributions in neonatal-perinatal medicine for health care students, professionals or the public. Pearlman, an expert in neonatology, intensive care and pediatrics, is clinical effectiveness officer for acute care at ChristianaCare. He is also professor of pediatrics at Sidney Kimmel College of Medicine at Thomas Jefferson University. “Stephen is deeply committed to excellence in neonatal education and the highest quality care,” said Kert Anzilotti, M.D.,MBA, system chief medical officer at ChristianaCare. “As a faculty member, physician and leader, he continues to make a lasting impact at ChristianaCare and beyond with his pioneering initiatives in quality improvement and safety in health care.” A faculty member for almost 40 years, Pearlman has served ChristianaCare in clinical, educational and administrative roles. Among them, he was chair of the Pediatric and Neonatal Safety Committee, director of Neonatal Quality Improvement, associate director of Neonatology and director of Pediatric Medical Education. Pearlman has led initiatives that have been spotlighted by the federal government as exemplars of how to improve safety at health systems. He developed an innovative quality-improvement curriculum for neonatal fellows, which the Organization of Neonatal-Perinatal Training Program Directors adopted. “I’m passionate about educating clinicians about ways to improve the quality of patient care, so it’s humbling to receive this recognition,” Pearlman said. “I am honored to have been selected as a recipient of this award.” Pearlman is also an associate editor of Quality Improvement for the Journal of Perinatology and an executive committee member of the American Academy of Pediatrics’ Perinatal Section.
Global Technology Outage Raises Concerns About Ease of Future Cybersecurity Attacks
The world came to a standstill after a technology outage reported Thursday evening grounded airplanes, disconnected hospitals and shut down banks across the globe. A faulty software update was to blame, not cybercriminals, but Florida Tech assistant professor TJ O’Connor said the outage’s cascading effect points to larger concerns about our society’s reliance on the internet. The outage, which affected users’ ability to access Microsoft 365 applications, was traced back to a defect found in a software update from cybersecurity company CrowdStrike. CrowdStrike quickly released a statement confirming that the outage was “not a security incident or cyberattack.” The outage was nonetheless damaging, kicking institutions offline. Issues remained more than a day later. “Once those services go down, there’s this massive cascading effect,” O’Conner said. “If bank processing doesn’t work, then aviation doesn’t work. If aviation doesn’t work, shipping doesn’t work.” Ultimately, O’Connor explained, the biggest concern isn’t the glitch in the system; it’s the number of systems that broke because CrowdStrike wasn’t working. “I think what we’ll see a lot of people learn from this CrowdStrike incident is…that if they want to take the internet down in the future, all they have to do is hit one target,” O’Connor said. “It makes the threat landscape a lot smaller to attack for an adversary.” Over the course of several hours, a blue Microsoft error screen taunted companies worldwide. Airlines including Delta, American and Frontier grounded all flights. Several television news outlets, including the United Kingdom’s Sky News, were unable to hold live broadcasts. Some of the biggest concerns lie in the hospital industry, where planning, evaluation and continuous monitoring are essential, O’Connor noted. “[Hospitals] are constantly processing so much data, and for them to go out for a couple of hours means that decisions aren’t being made on an automated basis,” O’Connor said. “We’ve kicked over so much of our decision making to automated systems that we can’t let those networks fail.” According to the United Kingdom’s National Health Service (NHS), the outage disrupted its appointment and patient record system. Mass General Brigham in Boston, Massachusetts was also one of several U.S. hospitals that cancelled non-urgent surgeries, procedures, and medical visits because of the disruption. 911 outages were also reported in several states, including Phoenix, Arizona, whose computerized dispatch center was affected, the police department posted on social media. In Portland, Oregon, Mayor Ted Wheeler issued a citywide state of emergency due to the outage’s impact on city servers, computers and emergency communications. Although CrowdStrike confirmed the incident was not malicious, O’Connor said it raises questions about overall reliance on the internet to make decisions, as well as ineffectiveness in securing it. “We continually have these wake-up moments where something happens, it’s large scale, it’s a news blip, and then we forget about it… but our adversaries don’t,” O’Connor said. “Unfortunately, the attack infrastructure and the ability to attack is getting easier and easier.” O’Connor also expects future network attacks to get worse, calling the unstable global environment a “national-level issue to address.” While large-scale attacks and outages are mostly out the individuals’ control, O’Connor said, people can take action to protect themselves from personal cybersecurity attacks by using multi-factor authentication as much as possible. Looking to know more? Dr. TJ O’Connor’s research is focused on cybersecurity education, wireless protocols, software-defined radio and machine learning. If you're looking to connect with Dr. O'Connor - simply click on his icon now to arrange an interview today.
The pandemic and who reacted better has been debate fodder for the campaigns of Donald Trump and Joe Biden already this election. The pandemic, preparing for the next one is just one of several key public health issues that America is dealing with. Opioids, obesity and nutrition are just a few others. And as the Republican National Convention 2024 begins, journalists from across the nation and the world will converge on Milwaukee, not only to cover the political spectacle but also to dig deeper on the key issues that may decide the election. To help visiting journalists navigate and understand the depth of Milwaukee's heritage and modern vibrancy, our MSOE experts are available to offer insights. Robin Gates is a nurse executive with a wide range of experience in community home, health and hospice, organ and tissue donation, managing primary care clinics, and clinical trials involving medical devices and pharmaceuticals. She has also worked as a nurse educator for health care organizations and higher education. . . . Robin Gates Assistant Professor, Nursing Expertise: Population health expert: understanding and addressing the diverse factors that influence health outcomes across different populations. View Profile “Leadership experience in various health care environments provides my ability to empower the next generations of nurses to understand the medical system for nursing practice wholistically,” said Gates. “Nurses are change agents. We are a pivotal part of a multidisciplinary team. I emphasize to nursing students their role in the community, corporations, hospitals, clinics, telehealth, home care and hospice, insurance, government and so on.” MSOE Online February 25, 2022 . . . For further information and to arrange interviews with our experts, please contact: JoEllen Burdue Senior Director of Communications and Media Relations Phone: (414) 839-0906 Email: burdue@msoe.edu . . . About Milwaukee School of Engineering (MSOE) Milwaukee School of Engineering is the university of choice for those seeking an inclusive community of experiential learners driven to solve the complex challenges of today and tomorrow. The independent, non-profit university has about 2,800 students and was founded in 1903. MSOE offers bachelor's and master's degrees in engineering, business and nursing. Faculty are student-focused experts who bring real-world experience into the classroom. This approach to learning makes students ready now as well as prepared for the future. Longstanding partnerships with business and industry leaders enable students to learn alongside professional mentors, and challenge them to go beyond what's possible. MSOE graduates are leaders of character, responsible professionals, passionate learners and value creators.
Cosmetic or Drug? The FDA's Classification of Sunscreen Limits Which Products Hit US Shelves
As stifling rays of sunshine beat down across the United States, it’s the time of year citizens flock to the store to load up on sun protection. It’s also the time of year consumers and media raise the annual question of why Europe is able to market sunscreen that contains more potentially effective ingredients, but the U.S. isn’t. The answer is not related to sunscreen or its ingredients, but rather how the country’s regulatory body – The Food and Drug Administration (FDA) – legally operates. “In order for the FDA to legally regulate products, those products are given classifying labels,” said Ana Santos Rutschman, a professor of law at Villanova University who studies health law. “A toothbrush, for instance, is labeled a medical device. That’s because it has to fit in one of the sources of authority of the FDA and the FDA, per the law, regulates drugs or medical devices.” Here is where it gets tricky. The FDA does not have to approve cosmetics, aside from certain color additives, before those products go to market. In the European Union’s European Medicines Agency (EMA), sunscreen is labeled as a cosmetic. Many other countries also classify it as such. In the U.S., however, sunscreen is labeled a drug because it has a therapeutic effect, and thus falls under the authority of the FDA. To make the classification system even more convoluted, some items are labeled as both a cosmetic and drug by the FDA. Shampoo, for instance, is inherently cosmetic. “But if it’s anti-dandruff shampoo, then it’s also a pharmaceutical,” said Santos Rutschman. “It’s super common for this to happen with a lot of products that you and I would not think are classified as drugs. It’s very natural under the regulatory regime that we have, but then it is very hard to bring anything to market – harder than other countries.” Case in point, sunscreen used in the EU that contains ingredients which may be more effective against certain types of ultraviolet rays cannot simply just come to market in the U.S. “If sunscreen fits the definition of a drug, then it must meet drug requirements,” said Santos Rutschman. “If you want a new drug to enter the U.S., you have to show efficacy and safety. But in order to do that, there must be clinical trials, and if those trials happened elsewhere, they would not conform to our domestic protocols. “Even if another country performed their own clinical trials, the odds the FDA would utilize the data are not incredibly high. If you think another country recognizes something we should, based on their data, then immediately this is going to raise questions of why we are deferring to a foreign regulator.” The FDA could go through the process of approving ingredients in question – and has indicated it will do so – but it’s a complicated process, and there is “also a matter of risk,” according to Santos Rutschman. “The FDA has always been less risk averse than its counterparts in Europe. I understand the market concerns, but this seems about right from a regulatory perspective… We aren’t talking about a specific drug that people need and cannot access. Sunscreen is available for the average American to purchase.” Barring an overhaul to the regulatory system in the U.S. to include an agency for cosmetics – an idea some argue has merit, but Santos Rutschman described as “not feasible” with the available funding – the only way Europe’s sunscreen would be available for Americans to purchase is if the FDA moved forward in regulating the ingredients. And that will continue to take time. “The FDA has never moved quickly on anything,” said Santos Rutschman. “It just can't.”
Expert Insight: Training Innovative AI to Provide Expert Guidance on Prescription Medications
A new wave of medications meant to treat Type II diabetes is grabbing headlines around the world for their ability to help people lose a significant amount of weight. They are called GLP-1 receptor agonists. By mimicking a glucagon-like peptide (GLP) naturally released by the body during digestion, they not only lower blood sugar but also slow digestion and increase the sense of fullness after eating. The two big names in GLP-1 agonists are Ozempic and Wegovy, and both are a form of semaglutide. Another medication, tirzepatide, is sold as Mounjaro and Zepbound. It is also a glucose-dependent insulinotropic polypeptide (GIP) agonist as well as GLP-1. Physicians have been prescribing semaglutide and tirzepatide with increasing frequency. However, both medications come with a host of side effects, including nausea and stomach pain, and are not suitable for every patient. Many clinics and physicians do not have immediate access to expert second opinions, as do the physicians at Emory Healthcare. Creating a Digital Twin That lack of an expert is one of the reasons Karl Kuhnert, professor in the practice of organization and management at Emory University’s Goizueta Business School, is using artificial intelligence to capture the expertise of physicians like Caroline Collins MD through the Tacit Object Modeler™, or TOM. By using TOM, developed by Merlynn Intelligence Technologies, Kuhnert and Collins can create her “decision-making digital twin.” This allows Collins to reveal her expertise as a primary care physician with Emory Healthcare and an Assistant Professor at Emory School of Medicine, where she has been leading the field in integrating lifestyle medicine into clinical practices and education. Traditional AI, like ChatGPT, uses massive amount of data points to predict outcomes using what’s known as explicit knowledge. But it isn’t necessarily learning as it goes. According to Kuhnert, TOM has been designed to learn how an expert, like Collins, decides whether or not to prescribe a drug like semaglutide to a patient. Wisdom or tacit knowledge is intuitive and rooted in experience and context. It is hard to communicate, and usually resides only in the expert’s mind. TOM’s ability to “peek into the expert’s mind makes it a compelling technology for accessing wisdom.” “Objective or explicit knowledge is known and can be shared with others,” says Kuhnert. "For example, ChatGPT uses explicit knowledge in its answers. It’s not creating something new. It may be new to you as you read it, but somebody, somewhere, before you, has created it. It’s understood as coming from some source." Karl Kuhnert “Tacit knowledge is subjective wisdom. Experts offer this, and we use their tacit know-how, their implicit knowledge, to make their decisions. If it were objective, everyone could do it. This is why we hire experts: They see things and know things others don’t; they see around corners.” Mimicking the Mind of a Medical Expert Teaching TOM to see around the corners requires Collins to work with the AI over the course of a few days. “Essentially what I do is I sit down with, in this case, a physician, and ask them, ‘What are thinking about when you make this decision?'” says Kuhnert. “The layperson might think that there are hundreds of variables in making a medical decision like this. With the expert’s tacit knowledge and experience, it is usually between seven and twelve variables. They decide based on these critical variables,” he says. "These experts have so much experience, they can cut away a lot of the noise around a decision and get right to the point and ask, ‘What am I looking at?’" Karl Kuhnert As TOM learns, it presents Collins with more and different scenarios for prescribing semaglutide. As she makes decisions, it remembers the variables present during her decision-making process. “Obviously, some variables are going to be more important than other variables. Certain combinations are going to be challenging,” says Collins. “Sometimes there are going to be some variables where I think, yes, this patient needs a GLP-1. Then there may be some variables where I think, no, this person really doesn’t need that. And which ones are going to win out? That’s really where TOM is valuable. It can say, okay, when in these difficult circumstances where there are conflicting variables, which one will ultimately be most important in making that decision?” The Process: Trusting AI After working with TOM for several hours, Collins will have reacted to enough scenarios for TOM to learn to make her decision. The Twin will need to demonstrate that it can replicate her decision-making with acceptable accuracy—high 90s to 100 percent. Once there, Collins’ Twin is ready to use. “I think it’s important to have concordance between what I would say in a situation and then what my digital twin would say in a situation because that’s our ultimate goal is to have an AI algorithm that can duplicate what my recommendation would be given these circumstances for a patient,” Collins says. “So, someone, whether that be an insurance company, or a patient themselves or another provider, would be able to consult TOM, and in essence, me, and say, in this scenario, would you prescribe a GLP-1 or not given this specific patient’s situation?” The patient’s current health and family history are critical when deciding whether or not to prescribe semaglutide. For example, according to Novo Nordisk, the makers of Ozempic, the drug should not be prescribed to patients with a history of problems with the pancreas or kidneys or with a family history of thyroid cancer. Those are just the start of a list of reasons why a patient may or may not be a good candidate for the medication. Kuhnert says, “What we’re learning is that there are so many primary care physicians right now that if you come in with a BMI over 25 and are prediabetic, you’re going to get (a prescription). But there’s much more data around this to suggest that there are people who are health marginalized, and they can’t do this. They should not have this (medication). It’s got to be distributed to people who can tolerate it and are safe.” Accessing the Digital Twin on TOM Collins’s digital twin could be available via something as easy to access as an iPhone app. “Part of my job is to provide the latest information to primary care physicians. Now, I can do this in a way that is very powerful for primary care physicians to go on their phones and put it in. It’s pretty remarkable, according to Colllins.” It is also transparent and importantly sourced information. Any physician using a digital twin created with TOM will know exactly whose expertise they are accessing, so anyone asking for a second opinion from Colllins will know they are using an expert physician from Emory University. In addition to patient safety, there are a number of ways TOM can be useful to the healthcare industry when prescribing medications like semaglutide. This includes interfacing with insurance companies and the prior approval process, often lengthy and handled by non-physician staff. “Why is a non-expert at an insurance company determining whether a patient needs a medication or not? Would it be better to have an expert?” says Collins. “I’m an expert in internal medicine and lifestyle medicine. So, I help people not only lose weight, but also help people change their behaviors to optimize their health. My take on GLP-1 medications is not that everyone needs them, it’s that they need to be utilized in a meaningful way, so patients will get benefit, given risks and benefits for these medications.” The Power of a Second Opinion Getting second, and sometimes third, opinions is a common practice among physicians and patients both. When a patient presents symptoms to their primary care physician, that physician may have studied the possible disease in school but isn’t necessarily an expert. In a community like Emory Healthcare, the experts are readily available, like Collins. She often serves as a second opinion for her colleagues and others around the country. “What we’re providing folks is more of a second opinion. Because we want this actually to work alongside someone, you can look at this opinion that this expert gave, and now, based on sourced information, you can choose. This person may be one of the best in the country, if not the world, in making this decision. But we’re not replacing people here. We’re not dislocating people with this technology. We need people. We need today’s and tomorrow’s experts as well,” according to Kuhnert. But also, you now have the ability to take an Emory physician’s diagnosing capabilities to physicians in rural areas and make use of this information, this knowledge, this decision, and how they make this decision. We have people here that could really help these small hospitals across the country. Caroline Collin MD Rural Americans have significant health disparities when compared to those living in urban centers. They are more likely to die from heart disease, cancer, injury, chronic respiratory disease, and stroke. Rural areas are finding primary care physicians in short supply, and patients in rural areas are 64 percent less likely to have access to medical specialists for needed referrals. Smaller communities might not have immediate access to experts like a rheumatologist, for example. In addition, patients in more rural areas might not have the means of transportation to get to a specialist, nor have the financial means to pay for specialized visits for a diagnosis. Collins posits that internal medicine generalists might suspect a diagnosis but want to confirm before prescribing a course of treatment. “If I have a patient for whom I am trying to answer a specific question, ‘Does this patient have lupus?’, for instance. I’m not going to be able to diagnose this person with lupus. I can suspect it, but I’m going to ask a rheumatologist. Let’s say I’m in a community where unfortunately, we don’t have a rheumatologist. The patient can’t see a rheumatologist. That’s a real scenario that’s happening in the United States right now. But now I can ask the digital twin acting as a rheumatologist, given these variables, ‘Does this patient have lupus?’ And the digital twin could give me a second opinion.” Sometimes, those experts are incredibly busy and might not have the physical availability for a full consult. In this case, someone could use TOM to create the digital twin of that expert. This allows them to give advice and second opinions to a wider range of fellow physicians. As Kuhnert says, TOM is not designed or intended to be a substitute for a physician. It should only work alongside one. Collins agreed, saying, “This doesn’t take the place of a provider in actual clinical decision-making. That’s where I think someone could use it inappropriately and could get patients into trouble. You still have to have a person there with clinical decision-making capacity to take on additional variables that TOM can’t yet do. And so that’s why it’s a second opinion.” “We’re not there yet in AI says Collins. We have to be really careful about having AI make actual medical decisions for people without someone there to say, ‘Wait a minute, does this make sense?’” AI Implications in the Classroom and Beyond Because organizations use TOM to create digital twins of their experts, the public cannot use the twins to shop for willing doctors. “We don’t want gaming the system,” says Collins. “We don’t want doctor shopping. What we want is a person there who can utilize AI in a meaningful way – not in a dangerous way. I think we’ll eventually get there where we can have AI making clinical decisions. But I don’t think I’d feel comfortable with that yet.” The implications of using decision-making digital twins in healthcare reach far beyond a second opinion for prescription drugs. Kuhnert sees it as an integral part of the future of medical school classrooms at Emory. In the past, teaching case studies have come from books, journals, and papers. Now, they could come alive in the classroom with AI simulation programs like TOM. "I think this would be great for teaching residents. Imagine that we could create a simulation and put this in a classroom, have (the students) do the simulation, and then have the physician come in and talk about how she makes her decisions." Karl Kuhnert “And then these residents could take this decision, and now it’s theirs. They can keep it with them. It would be awesome to have a library of critical health decisions made in Emory hospitals,” Kuhnert says. Collins agreed. “We do a lot of case teaching in the medical school. I teach both residents and medical students at Emory School of Medicine. This would be a really great tool to say, okay, given these set of circumstances, what decision would you make for this patient? Then, you could see what the expert’s decision would have been. That could be a great way to see if you are actually in lockstep with the decision-making process that you’re supposed to be learning.” Kuhnert sees decision-making twins moving beyond the healthcare system and into other arenas like the courtroom, public safety, and financial industries and has been working with other experts to digitize their knowledge in those fields. "The way to think about this is: say there is a subjective decision that gets made that has significant ramifications for that company and maybe for the community. What would it mean if I could digitize experts and make it available to other people who need an expert or an expert’s decision-making?" Karl Kuhnert “You think about how many people aren’t available. Maybe you have a physician who’s not available. You have executives who are not available. Often expertise resides in the minds of just a few people in an organization,” says Kuhnert. “Pursuing the use of technologies like TOM takes the concept of the digital human expert from simple task automation to subjective human decision-making support and will expand the idea of a digital expert into something beyond our current capabilities,” Kuhnert says. “I wanted to show that we could digitize very subjective decisions in such areas as ethical and clinical decision-making. In the near future, we will all learn from the wisdom codified in decision-making digital twins. Why not learn from the best? There is a lot of good work to do.” Karl Kuhnert is a Professor in the Practice of Organization & Management and Associate Professor of Psychiatry, School of Medicine and Senior Faculty Fellow of the Emory Ethics Center. If you're looking to connect with Karl to know more - simply click on his icon now to arrange a time to talk today.
Small Changes Can Save Lives: How a Police Officer’s First Words Can Transform Communities
Britt Nestor knew something needed to change. Nestor is a police officer in North Carolina. Unlike many in her field, who recite interview-ready responses about wanting to be a police officer since childhood, Nestor admits that her arrival to the field of law enforcement was a serendipitous one. Told by teachers to start rehearsing the line “do you want fries with that?” while in high school, Nestor went to college to prove them wrong—and even graduated with a 3.9 GPA solely to prove those same people wrong—but she had absolutely no idea what to do next. When a local police department offered to put her through the police academy, her first thought was, “absolutely not.” “And here I am,” says Nestor, 12 years into her career, working in Special Victims Investigations as an Internet Crimes Against Children detective. A Calling to Serve Community Brittany Nestor, New Blue Co-Founder and President Though she’d initially joined on a whim, Nestor stuck around and endured many growing pains, tasting some of the problematic elements of police culture firsthand. As a woman, there was particular pressure to prove herself; she resisted calling for back-up on dangerous calls for fear of being regarded as weak, and tried out for and joined the SWAT team to demonstrate her mettle. "It took time to realize I didn’t need to make the most arrests or get the most drugs and guns to be a good cop. What was important was recognizing that I was uniquely positioned and given opportunities every single shift to make a difference in people’s lives—that is what I wanted to focus on." Britt Nestor Nestor found she took great pleasure in interacting with different kinds of people all day. She’s deeply fond of her community, where she is also a youth basketball coach. One of her greatest joys is being on call or working an event and hearing someone hail her from the crowd by yelling, “hey, coach!” When she landed in the Juvenile Investigations Unit, Nestor truly felt she’d found her calling. Still, what she’d witnessed in her profession and in the news weighed on her. And she’s not alone; while there is continued debate on the urgency and extent of changes needed, 89% percent of people are in favor of police reform, according to a CBS/YouGov poll. A few weeks after George Floyd’s murder in 2020, Nestor’s colleague Andy Saunders called her and told her they had to do something. It felt like the tipping point. “I knew he was right. I needed to stop wishing and hoping police would do better and start making it happen.” Andy Saunders, New Blue Co-Founder and CEO That conversation was the spark that grew into New Blue. Founded in 2020, New Blue strives to reform the U.S. Criminal Justice system by uniting reform-minded police officers and community allies. The organization focuses on incubating crowd-sourced solutions from officers themselves, encouraging those in the field to speak up about what they think could improve relations between officers and the communities they serve. “Over the years I’ve had so many ideas—often addressing problems brought to light by community members—that could have made us better. But my voice was lost. I didn’t have much support from the police force standing behind me. This is where New Blue makes the difference; it’s the network of fellows, alumni, partners, mentors, and instructors I’d needed in the past.” Nestor and Saunders had valuable pieces of the puzzle as experienced law enforcement professionals, yet they knew they needed additional tools. What are the ethical guidelines around experimenting with new policing tactics? What does success look like, and how could they measure it? The Research Lens Over 400 miles away, another spark found kindling; like Nestor, Assistant Professor of Organization & Management Andrea Dittmann’s passion for making the world a better place is palpable. Also, like Nestor, it was an avid conversation with a colleague—Kyle Dobson—that helped bring a profound interest in police reform into focus. Dittmann, whose academic career began in psychology and statistics, came to this field by way of a burgeoning interest in the need for research-informed policy. Much of her research explores the ways in which socioeconomic disparities play out in the work environment, and—more broadly—how discrepancies of power shape dynamics in organizations of all kinds. When people imagine research in the business sector, law enforcement is unlikely to crop up in their mind. Indeed, Dittmann cites the fields of criminal justice and social work as being the traditional patrons of police research, both of which are more likely to examine the police force from the top down. Andrea Dittmann Dittmann, however, is a micro-oriented researcher, which means she assesses organizations from the bottom up; she examines the small, lesser-studied everyday habits that come to represent an organization’s values. “We have a social psychology bent; we tend to focus on individual processes, or interpersonal interactions,” says Dittmann. She regards her work and that of her colleagues as a complementary perspective to help build upon the literature already available. Where Dittmann has eyes on the infantry level experience of the battleground, other researchers are observing from a bird’s eye view. Together, these angles can help complete the picture. And while the “office” of a police officer may look very different from what most of us see every day, the police force is—at the end of the day—an organization: “Like all organizations, they have a unique culture and specific goals or tasks that their employees need to engage in on a day-to-day basis to be effective at their jobs,” says Dittmann. Theory Meets Practice Kyle Dobson, Postdoctoral Researcher at The University of Texas at Austin What Dittmann and Dobson needed next was a police department willing to work with them, a feat easier said than done. Enter Britt Nestor and New Blue. "Kyle and I could instantly tell we had met people with the same goals and approach to reforming policing from within." Andrea Dittmann Dittmann was not surprised by the time it took to get permission to work with active officers. “Initially, many officers were distrustful of researchers. Often what they’re seeing in the news are researchers coming in, telling them all the problems that they have, and leaving. We had to reassure them that we weren’t going to leave them high and dry. If we find a problem, we’re going to tell you about it, and we’ll work on building a solution with you. And of course, we don’t assume that we have all the answers, which is why we emphasize developing research ideas through embedding ourselves in police organizations through ride-alongs and interviews.” After observing the same officers over years, they’re able to build rapport in ways that permit open conversations. Dittmann and Dobson now have research running in many pockets across the country, including Atlanta, Baltimore, Chicago, Washington, D.C. and parts of Texas. The Rise of Community-Oriented Policing For many police departments across the nation, there is a strong push to build closer and better relationships with the communities they serve. This often translates to police officers being encouraged to engage with citizens informally and outside the context of enforcing the law. If police spent more time chatting with people at a public park or at a café, they’d have a better chance to build rapport and foster a collective sense of community caretaking—or so the thinking goes. Such work is often assigned to a particular unit within the police force. This is the fundamental principle behind community-oriented policing: a cop is part of the community, not outside or above it. This approach is not without controversy, as many would argue that the public is better served by police officers interacting with citizens less, not more. In light of the many high-profile instances of police brutality leaving names like Breonna Taylor and George Floyd echoing in the public’s ears, their reticence to support increased police-to-citizen interaction is understandable. “Sometimes when I discuss this research, people say, ‘I just don’t think that officers should approach community members at all, because that’s how things escalate.’ Kyle and I acknowledge that’s a very important debate and has its merits.” As micro-oriented researchers, however, Dittmann and Dobson forgo advocating for or dismissing broad policy. They begin with the environment handed to them and work backward. “The present and immediate reality is that there are officers on the street, and they’re having these interactions every day. So what can we do now to make those interactions go more smoothly? What constitutes a positive interaction with a police officer, and what does it look like in the field?” Good Intentions Gone Awry To find out, they pulled data through a variety of experiments, including live interactions, video studies and online experiments, relying heavily on observation of such police-to-citizen interactions. "What we wanted to do is observe the heterogeneity of police interactions and see if there’s anything that officers are already doing that seems to be working out in the field, and if we can ‘bottle that up’ and turn that into a scalable finding." Andrea Dittmann Dittmann and her colleagues quickly discovered a significant discrepancy between some police officers’ perceived outcome of their interactions with citizens and what those citizens reported to researchers post-interaction. “An officer would come back to us and they’d say it went great. Like, ‘I did what I was supposed to do, I made that really positive connection.’ And then we’d go to the community members, and we’d hear a very different story: ‘Why the heck did that officer just come up to me, I’m just trying to have a picnic in the park with my family, did I do something wrong?’” Community members reported feeling confused, harassed, or—at the worst end of the spectrum—threatened. The vast majority—around 75% of citizens—reported being anxious from the very beginning of the interaction. It’s not hard to imagine how an officer approaching you apropos of nothing may stir anxious thoughts: have I done something wrong? Is there trouble in the area? The situation put the cognitive burden on the citizen to figure out why they were being approached. The Transformational Potential of the “Transparency Statement” And yet, they also observed officers (“super star” police officers, as Dittmann refers to them) who seemed to be especially gifted at cultivating better responses from community members. What made the difference? “They would explain themselves right from the start and say something like, ‘Hey, I’m officer so-and-so. The reason I’m out here today is because I’m part of this new community policing unit. We’re trying to get to know the community and to better understand the issues that you’re facing.’ And that was the lightbulb moment for me and Kyle: the difference here is that some of these officers are explaining themselves very clearly, making their benevolent intention for the interaction known right from the start of the conversation.” Dittmann and her colleagues have coined this phenomenon the “transparency statement.” Using a tool called the Linguistic Inquiry & Word Count software and natural language processing tools, the research team was able to analyze transcripts of the conversations and tease out subconscious cues about the civilians’ emotional state, in addition to collecting surveys from them after the encounter. Some results jumped out quickly, like the fact that those people whose conversation with an officer began with a transparency statement had significantly longer conversations with them. The team also employed ambulatory physiological sensors, or sensors worn on the wrist that measure skin conductivity and, by proxy, sympathetic nervous system arousal. From this data, a pattern quickly emerged: citizens’ skin conductance levels piqued early after a transparency statement (while this can be a sign of stress, in this context researchers determined it to reflect “active engagement” in the conversation) and then recovered to baseline levels faster than in the control group, a pattern indicative of positive social interaction. Timing, too, is of the essence: according to the study, “many patrol officers typically made transparency statements only after trust had been compromised.” Stated simply, the interest police officers showed in them was “perceived as harassment” if context wasn’t provided first. Overall, the effect was profound: citizens who were greeted with the transparency statement were “less than half as likely to report threatened emotions.” In fact, according to the study, “twice as many community members reported feeling inspired by the end of the interaction.” What’s more, they found that civilians of color and those from lower socioeconomic backgrounds —who may reasonably be expected to have a lower baseline level of trust of law enforcement—“may profit more from greater transparency.” Talk, it turns out, is not so cheap after all. Corporate Offices, Clinics, and Classrooms The implications of this research may also extend beyond the particulars of the police force. The sticky dynamics that form between power discrepancies are replicated in many environments: the classroom, between teachers and students; the office, between managers and employees; even the clinic, between medical doctors and patients. In any of these cases, a person with authority—perceived or enforceable—may try to build relationships and ask well-meaning questions that make people anxious if misunderstood. Is my boss checking in on me because she’s disappointed in my performance? Is the doctor being nice because they’re preparing me for bad news? “We believe that, with calibration to the specific dynamics of different work environments, transparency statements could have the potential to ease tense conversations across power disparities in contexts beyond policing,” says Dittmann. More Research, Action, and Optimism What could this mean for policing down the road? Imagine a future where most of the community has a positive relationship with law enforcement and there is mutual trust. "I often heard from family and friends that they’d trust the police more ‘if they were all like you.’ I can hear myself saying, ‘There are lots of police just like me!’ and I truly believe that. I believe that so many officers love people and want to serve their communities—and I believe a lot of them struggle with the same things I do. They want to see our profession do better!" Britt Nestor “When I get a new case and I meet the survivor, and they’re old enough to talk with me, I always explain to them, ‘I work for you. How cool is that?’ And I truly believe this: I work for these kids and their families.” The implications run deep; a citizen may be more likely to reach out to police officers about issues in their community before they become larger problems. An officer who is not on edge may be less likely to react with force. Dittmann is quick to acknowledge that while the results of the transparency statement are very promising, they are just one piece of a very large story with a long and loaded history. Too many communities are under supported and overpoliced; it would be denying the gravity and complexity of the issue to suggest that there is any silver bullet solution, especially one so simple. More must be done to prevent the dynamics that lead to police violence to begin with. “There’s a common narrative in the media these days that it’s too late, there’s nothing that officers can do,” says Dittmann. Yet Dittmann places value on continued research, action and optimism. When a simple act on the intervention side of affairs has such profound implications, and is not expensive or difficult to implement, one can’t help but see potential. “Our next step now is to develop training on transparency statements, potentially for entire agencies,” says Dittmann. “If all the officers in the agency are interacting with transparency statements, then we see this bottom-up approach, with strong potential to scale. If every interaction you have with an officer in your community starts out with that transparency statement, and then goes smoothly, now we’re kind of getting to a place where we can hopefully talk about better relations, more trust in the community, at a higher, more holistic, level.” While the road ahead is long and uncertain, Dittmann’s optimism is boosted by one aspect of her findings: those community members who reported feeling inspired after speaking with police officers who made their benevolent intentions clear. "That was really powerful for me and Kyle. That’s what gets me out of bed in the morning. It’s worth trying to move the needle, even just a little bit." Andrea Dittmann Looking to know more? Andrea Dittman is available to speak with media about this important research. Simply click on her icon now to arrange an interview today.
Aston University researcher takes on leadership role within biomedical engineering
Dr Antonio Fratini is the new chair of the Institute of Mechanical Engineers Biomedical Engineering Division It is one of the largest group of professional biomedical engineers in the UK The specialism merges professional engineering with medical knowledge of the human body, such as artificial limbs and robotic surgery. An Aston University researcher has been given a leading role within the biomedical engineering sector. Dr Antonio Fratini CEng MIMechE has been elected as the new chair of the Biomedical Engineering Division (BmED) of the Institution of Mechanical Engineers (IMechE), one of the largest groups of professional biomedical engineers in the UK. The IMechE has around 115,000 members in 140 countries and has been active since 1847. Biomedical engineering, also known as medical engineering or bioengineering, is the integration of engineering with medical knowledge to help tackle clinical problems and improve healthcare outcomes. Dr Fratini previously served as chair of the Birmingham centre of the division for five years and as vice-chair of the division for one year. His research includes responsible use of AI, 3D segmentation and anatomical modelling to improve surgical training and planning, motor functions and balance rehabilitation. He leads Aston University’s Engineering for Health Research Centre within the College of Engineering and Physical Sciences and has vast experience in the design, development and testing of new medical devices. Currently he is the University’s principal investigator for the West Midlands Health Tech Innovation Accelerator and he has a growing reputation in the UK and internationally within the biomedical engineering profession. He said: “Biomedical engineering is continuously evolving and our graduates will create the future of health tech and med tech for more effective, sustainable, responsible and personalised healthcare. “I am very honoured of this appointment. This three-year post will be a great opportunity to further develop the biomedical engineering profession worldwide and to show Aston University’s commitment to an inclusive, entrepreneurial and transformational impact within the field.” Professor Helen Meese, outgoing chair of the division, said: “I am delighted to see Antonio take on the chair’s position. He has, over the years, contributed significantly to the growth of the Birmingham regional centre and has actively supported me throughout my tenure as chair. I know how passionate he is about our profession and will undoubtedly continue to drive the division forward over the next three years.” Dr Frattini was presented with his new title on 20 June at the IMECHE HQ at 1 Birdcage Walk, London during the Institution’s technology strategy board meeting. For media inquiries in relation to this release, contact Nicola Jones, Press and Communications Manager, on (+44) 7825 342091 or email: n.jones6@aston.ac.uk
