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Expert Opinion - The Undisclosed Risks of Off-brand Ozempic and Other Weight Loss Products
The popularity -- and price -- of brand-name injectable drugs like Ozempic, Wegovy, Mounjaro, and Zepbound has skyrocketed. But the soaring demand for these drugs -- used for weight loss as well as to control blood sugar levels and reduce the risk of heart disease -- and the limited supply as well as lack of generic options has also led to a flood of non-brand alternatives in the market. In a recent article for The Conversation, UConn expert C. Michael White, Distinguished Professor of Pharmacy Practice, issued a warning to consumers about the potential undisclosed risks of these off-brand products: High demand is driving GLP-1 wannabes The dietary supplement market has sought to cash in on the GLP-1 demand with pills, teas, extracts and all manner of other products that claim to produce similar effects as the brand names at a much lower price. Products containing the herb berberine offer only a few pounds of weight loss, while many dietary supplement weight loss products contain stimulants such as sibutramine and laxatives such as phenolphthalein, which increase the risk of heart attacks, strokes and cancer. The role of compounding pharmacies Unlike the dietary supplements that are masquerading as GLP-1 weight loss products, compounding pharmacies can create custom versions of products that contain the same active ingredients as the real thing for patients who cannot use either brand or generic products for some reason. These pharmacies can also produce alternative versions of brand-name drugs when official drug shortages exist. Since the demand for GLP-1 medications has far outpaced the supply, compounding pharmacies are legally producing a variety of different semaglutide and tirzepatide products. These products may come in versions that differ from the brand-name companies, such as vials of powder that must be dissolved in liquid, or as tablets or nasal sprays. Just like the brand-name drugs, you must have a valid prescription to receive them. The prices range from $250-$400 a month – still a steep price for many consumers. Compounding pharmacies must adhere to the FDA’s sterility and quality production methods, but these rules are not as rigorous for compounding pharmacies as those for commercial manufacturers of generic drugs. In addition, the products compounding pharmacies create do not have to be tested in humans for safety or effectiveness like brand-name products do. Proper dosing can also be challenging with compounded forms of the drugs. Companies that work the system For people who cannot afford a compounding pharmacy product, or cannot get a valid prescription for semaglutide or tirzepatide, opportunistic companies are stepping in to fill the void. These include “peptide companies,” manufacturers that create non-FDA approved knockoff versions of the drugs. From November 2023 to March 2024, my team carried out a study to assess which of these peptide companies are selling semaglutide or tirzepatide products. We scoured the internet looking for these peptide companies and collected information about what they were selling and their sales practices. We found that peptide sellers use a loophole to sell these drugs. On their websites, the companies state that their drugs are for “research purposes only” or “not for human consumption,” but they do nothing to verify that the buyers are researchers or that the product is going to a research facility. By reading the comments sections of the company websites and the targeted ads on social media, it becomes clear that both buyers and sellers understand the charade. Unlike compounding pharmacies, these peptide sellers do not provide the supplies you need to dissolve and inject the drug, provide no instructions, and will usually not answer questions. Peptide sellers, since they allegedly are not selling to consumers, do not require a valid prescription and will sell consumers whatever quantity of drug they wish to purchase. Even if a person has an eating disorder such as anorexia nervosa, the companies will happily sell them a semaglutide or tirzepatide product without a prescription. The average prices of these peptide products range from $181-$203 per month. Skirting regulations Peptide sellers do not have to adhere to the rules or regulations that drug manufacturers or compounding pharmacies do. Many companies state that their products are 99% pure, but an independent investigation of three companies’ products from August 2023 to March 2024 found that the purity of the products were far less than promised. One product contained endotoxin – a toxic substance produced by bacteria – suggesting that it was contaminated with microbes. In addition, the products’ promised dosages were off by up 29% to 39%. Poor purity can cause patients to experience fever, chills, nausea, skin irritation, infections and low blood pressure. In this study, some companies never even shipped the drug, telling the buyers they needed to pay an additional fee to have the product clear customs. If a consumer is harmed by a poor-quality product, it would be difficult to sue the seller, since the products specifically say they are “not for human consumption.” Ultimately, consumers are being led to spend money on products that may never arrive, could cause an infection, might not have the correct dose, and contain no instructions on how to safely use or store the product. Dr. C. Michael White is an expert in the areas of comparative effectiveness and preventing adverse events from drugs, devices, dietary supplements, and illicit substances. Dr. White is available to speak with media -- click on his icon now to arrange an interview today.
Curbing toxic metals in baby food
Rice is a staple food for babies and young children. But heavy metals and metalloids such as cadmium and arsenic found in rice could hinder their brain development. University of Delaware researchers grew rice on 18 small fields, exposing the rice paddies to different flooding and wet conditions. Once they harvested the grain, they analyzed how much arsenic and cadmium — two toxic elements — remained in it. They found flooded rice fields tend to have higher amounts of arsenic and lower amounts of cadmium while drier rice fields have lower amounts of arsenic and higher amounts of cadmium. Angelia Seyfferth, a UD soil biogeochemist and professor in the Department of Plant and Soil Sciences, says the findings present a bit of a puzzle. “There’s a challenge,” Seyfferth said. “It basically resides in what is this magic number or magic water status in the soil to try to minimize both of them. There really isn’t one that is universal across all soils.” The findings could help shape policy as the U.S. Food and Drug Administration could release new regulations for arsenic and cadmium in infant food by the end of the year, part of its Closer to Zero Action Plan to reduce infants’ and children’s exposure to contaminants in food. To contact Seyfferth to learn more about this research, visit her ExpertFile profile or click the contact button.
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.”
Higher education, biotech and innovation - will the future be part of the 2024 campaign?
As the RNC brings national attention to Milwaukee, discussions are expected to cover pivotal topics such as biotechnology, innovation, and higher education. 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 these issues and how and where the Republican policies are taking on these topics our MSOE experts are available to offer insights. Dr. Wujie Zhang, Dr. Jung Lee, Dr. Eric Baumgartner, Dr. Candela Marini, and Dr. John Walz are leading voices nationally on these important subjects and are ready to assist with any stories during the convention. Dr. John Walz President Expertise: Thought leadership on higher education, relevancy and value of higher ed View Profile “Engineering is not a very diverse field,” Walz said. “I want to continue to push those boundaries and make our programs open, to see more and more under-represented students come here and succeed here, and do well here.” MSOE president John Walz works to make 'hidden gem' not so hidden. Milwaukee Journal Sentinel May 17, 2023 Dr. Wujie Zhang Professor, Chemical and Biomolecular Engineering Expertise: Biomaterials; Regenerative Medicine and Tissue Engineering; Micro/Nano-technology; Drug Delivery; Stem Cell Research; Cancer Treatment; Cryobiology; Food Science and Engineering (Fluent in Chinese and English) View Profile “We accidentally noticed that we can make the hydrogel particle red blood cell shaped,” he explains. “We started then to make artificial red blood cells to mimic pretty much all aspects of red blood cells.” You're Somebody's Type MKE Lifestyle January 24, 2020 Dr. Jung Lee Professor, Chemical and Biomolecular Engineering Expertise: Bioinformatics, drug design and molecular modeling. View Profile Dr. Eric Baumgartner Executive Vice President of Academics Expertise: Thought leadership on higher education, relevancy and value of higher ed, role of A.I. in future degrees and workforce development. View Profile MSOE serves as an educational resource to Wisconsin companies is building an A.I.-ready workforce. In 2018 MSOE was the first in the nation to launch a B.S. in Computer Science with a sole focus on A.I. and machine learning. Wisconsin Governor’s Task Force on Workforce and Artificial Intelligence December, 2023 Dr. Candela Marini Assistant Professor Expertise: Latin American Studies and Visual Culture View Profile “Contrary to stereotypical images of Native Americans trying to stop ‘progress’ by fighting against mines and pipelines projects, the Menominees’ sustainable forestry stands out as a clear example of resource management that actually thinks about, and works for, the future,” said Marini. The MSOE Mindset visits the Menominee Indian Reservation MSOE Online April 11, 2019 . . . Media Relations Contact To schedule an interview or for more information, 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.
Milwaukee-Based Experts Available During 2024 Republican National Convention
Journalists attending the Republican National Convention (RNC) are invited to engage with leading Milwaukee School of Engineering (MSOE) experts in a range of fields, including artificial intelligence (AI), machine learning, cybersecurity, urban studies, biotechnology, population health, water resources, and higher education. MSOE media relations are available to identify key experts and assist in setting up interviews (See contact details below). As the RNC brings national attention to Milwaukee, discussions are expected to cover pivotal topics such as national security, technological innovation, urban development, and higher education. MSOE's experts are well-positioned to provide research and insights, as well as local context for your coverage. Artificial Intelligence, Machine Learning, Cybersecurity Dr. Jeremy Kedziora Associate Professor, PieperPower Endowed Chair in Artificial Intelligence Expertise: AI, machine learning, ChatGPT, ethics of AI, global technology revolution, using these tools to solve business problems or advance business objectives, political science. View Profile Dr. Derek Riley Professor, B.S. in Computer Science Program Director Expertise: AI, machine learning, facial recognition, deep learning, high performance computing, mobile computing, artificial intelligence View Profile Dr. Walter Schilling Professor Expertise: Cybersecurity and the latest technological advancements in automobiles and home automation systems; how individuals can protect their business operations and personal networks. View Profile Milwaukee and Wisconsin: Culture, Architecture & Urban Planning, Design Dr. Michael Carriere Professor, Honors Program Director Expertise: an urban historian, with expertise in American history, urban studies and sustainability; growth of Milwaukee's neighborhoods, the challenges many of them are facing, and some of the solutions that are being implemented. Dr. Carriere is an expert in Milwaukee and Wisconsin history and politics, urban agriculture, creative placemaking, and the Milwaukee music scene. View Profile Kurt Zimmerman Assistant Professor Expertise: Architectural history of Milwaukee, architecture, urban planning and sustainable design. View Profile Biotechnology Dr. Wujie Zhang Professor, Chemical and Biomolecular Engineering Expertise: Biomaterials; Regenerative Medicine and Tissue Engineering; Micro/Nano-technology; Drug Delivery; Stem Cell Research; Cancer Treatment; Cryobiology; Food Science and Engineering (Fluent in Chinese and English) View Profile Dr. Jung Lee Professor, Chemical and Biomolecular Engineering Expertise: Bioinformatics, drug design and molecular modeling. View Profile Population Health Robin Gates Assistant Professor, Nursing Expertise: Population health expert: understanding and addressing the diverse factors that influence health outcomes across different populations. View Profile Water Resources Dr. William Gonwa Professor, Civil Engineering Expertise: Water Resources, Sewers, Storm Water, Civil Engineering education View Profile Higher Education Dr. Eric Baumgartner Executive Vice President of Academics Expertise: Thought leadership on higher education, relevancy and value of higher ed, role of A.I. in future degrees and workforce development. View Profile Dr. Candela Marini Assistant Professor Expertise: Latin American Studies and Visual Culture View Profile Dr. John Walz President Expertise: Thought leadership on higher education, relevancy and value of higher ed View Profile Media Relations Contact To schedule an interview or for more information, 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.
New research from Goizueta’s Diwas KC unpacks the dual impact of Prescription Drug Monitoring Programs on opioid prescriptions and heroin overdose deaths. More than two million individuals in the US are experiencing Opioid Use Disorder (OUD). The CDC defines OUD as “a problematic pattern of opioid use that causes significant impairment or distress.” Around 130 people die of opioid overdoses every day. Perhaps more startlingly, four million people over the age of 12 have reported using pain medication recreationally, including opioids. Prescription opioids are a highly-regulated class of drug. They interact with the opioid receptors on nerve cells throughout the body, as well as the brain, which reduces the intensity of pain signals to the body. For many, they are a necessary prescription to get through the pain of surgery or injury, as the body heals itself. Unfortunately, the function of opioids in the body—releasing endorphins and boosting feelings of pleasure, as well as reducing pain—also make them highly addictive. PDMP: A Successful Federal Mandate The United States continues to see increases in deaths from opioid overdoses. So, federal and state governments have been working in enact policies that are designed to decrease those fatalities. One of the methods states are using to prevent common abuse patterns like “doctor shopping,” which is the pattern of visiting multiple physicians to obtain prescriptions, is the Prescription Drug Monitoring Program (PDMP), designed to be used in conjunction with Health Information Technology (HIT) programs. PDMP serve two purposes: identifying drug-seeking behaviors in patients, and identifying physicians with patterns of inappropriate prescribing. Nearly all 50 states have enacted PDMPs of some degree. Some programs require physicians to check the PDMP before prescribing restricted pharmaceuticals, but in others it’s only suggested. Intrastate communication between PDMPs is not always possible, however. The Unintended Consequences The use of PDMPs has been shown to reduce the number of opioid prescriptions, the intended outcome of the program. Enter a recently published study by Diwas KC, Goizueta Foundation Term Professor of Information Systems & Operations Management. The research shows that during time the research was conducted, prescriptions for opioids declined by 6.1%. However, the research also brought to light a very serious and unintended consequence of the implementation of PDMPs. The study concluded that while the implementation of PDMPs did reduce opioid prescriptions, it did not reduce overall numbers of prescription opioid deaths. In fact, it may have contributed to a 50% increase in heroin overdose fatalities. “The heroin increase was definitely something we were not expecting, it was a total surprise,” says KC. "It was something that we had hypothesized. You’ve got a bunch of individuals who have used prescription opiates and had presumably been dependent. Now with the passage of this PDMP law, it has become more difficult to obtain prescription opiates. Therefore, some people might be forced to turn to the street version of it." Diwas KC “We didn’t expect the effect size it to be as significant as it is,” says KC. Heroin and commonly prescribed opioids like oxycodone and hydrocodone are very similar on a biochemical level. What’s more, they generate a similar sensation in the body, according to KC. That’s why he and his team had the initial hypothesis that some addicted individuals, when unable to get prescription medication, might turn to street drugs, which are much more dangerous on many levels. “There are many aspects to this. One has to do with the potency and the toxicity of the things you get on the streets. There are very little checks and balances on those. There’s no control in quality for sure,” KC says. He also notes the lack of checks and balances on the frequency of usage. “So the frequency of usage, the quality of the substances you’re putting inside your body, and possibly the circumstances of acquiring it might also be very risky too.” A Dual Impact The research concludes that mandating PDMP use is an example of a successful use of policy for intervention. It does, in fact, decrease the number of opioid prescriptions available to patients. That’s critical information for policy makers and physicians to take in. And it’s a solid reason to keep using and expanding PDMP usage, according to KC. "I should point out very clearly that the policy did have the intended effect of reducing prescriptions. So, it definitely benefited people who might otherwise have become addicted." Diwas KC “By reducing unnecessary prescriptions it might have limited the number of people who would have gotten hooked on the drugs in the first place. So there’s definitely the benefit of that,” says KC. “It’s just that when the policy was implemented, there was also this side effect because of people who were already using it. So, when those people were forced to look for alternatives, that’s when things got bad.” Research papers like this one show an important side of using data to mark successes and failures of government policies. Taken on the surface, data can show a policy’s impact for the greater good. But a deeper dive into the surrounding data—like the increase in heroin use after the implementation of PDMPs—gives everyone a better idea of the full impact of this mandate. "Policies have intended as well as unintended consequences. In this case of PDMP it had the desired effect of reducing prescriptions. That probably helped a lot of people not get addicted to opiates in the first place." Diwas KC “But sometimes policies also have unintended consequences,” says KC. “Like in the case of people who were already addicted to painkillers suddenly stopping it, causing them to take drastic actions, and that’s what happened for some of the people in the study. Policies need to consider the possibility of unintended consequences and take actions to also mitigate those unintended consequences.” Interested in knowing more? Diwas KC is the Goizueta Foundation Term Professor of Information Systems & Operations Management. He is available to talk about this important topic - simply click on his icon now to arrange an interview today
MESOX, a spin-out from the pharmaceutics group at Aston Pharmacy School, develops drug carrier technology to improve medicine formulations The company won the Start-Up prize at the Medilink Midlands Awards 2024 The prize is awarded to a new company that shows a promising future. A spin-out company from Aston University’s pharmaceutics research group has won a medical technology and life sciences industry award. MESOX, which was founded by Aston University pharmaceutics lecturer Dr Ali Al-Khattawi, won the Medilink Midlands Start-Up Award, which is presented to a newly established company that shows a promising future. The Medilink Midlands Business Awards showcase the best collaborations between industry, academia and the NHS across the Midlands. This year’s ceremony was held at the Athena in Leicester on 9 May. The awards were established by Medilink Midlands, which provides specialist business support to boost the region’s economic output from the life sciences industry. Working alongside the Midlands Engine and other strategic alliances, it helps stimulate additional and value-added growth of the Midlands as a prosperous community for life sciences. With in-depth expertise in particle engineering for drug delivery and pharmaceutical spray drying, MESOX uses IP-protected carriers to improve the bioavailability and efficacy of pharmaceuticals, partnering with pharmaceutical and biotechnology companies to bring challenging therapeutics to market. In its citation, Medilink Midlands described MESOX as “transforming pharmaceutical formulation with its game-changing carrier technologies.” As a winner of a Medilink Midlands award, MESOX will now be entered into the UK National Awards, the ceremony of which takes place on 11 July 2024 in London. Dr Al-Khattawi said: “We are delighted to have won this prestigious award, which highlights the outstanding research and development work being done by the MESOX team and the immense potential of our company to transform the medicine formulation development landscape. Through collaboration with other pharmaceutical companies, clinicians, academic researchers, and by engaging directly with patients to understand their needs, we aim to innovate and advance drug delivery science into life-saving therapeutics. “At MESOX, our ambition is to be a global, research-based pharmaceutical company rooted in the Midlands, dedicated to developing life-saving therapeutics at speed and resource-efficiency. Our ultimate goal is to enable healthier lives for patients worldwide and ensure better global access to essential medicines.”
This Is a Critical Moment: Delaware Must Not Go Backward in Health Equity
The proposed Delaware House Bill 350 is well-intended but would have terrible consequences for Delaware’s most vulnerable populations. There is a better way. By LeRoi S. Hicks, M.D., MPH, FACP As a Black physician who has dedicated his 25-year career to understanding and addressing health equity, I am deeply concerned about Delaware’s proposed House Bill 350, which aims to address rising health care costs by establishing a body of political appointees that would oversee the budgets of Delaware’s nonprofit hospitals. While the goal of bending the cost curve in health care may be well-intentioned, this bill will have horrific consequences for Delaware’s most vulnerable populations, including Black people, Hispanic people and other groups that have been traditionally underserved in health care. We can and must work together to solve this problem and provide the right care, in the right place, at the right time. A tale of two cities To borrow a phrase from Charles Dickens, Delaware, like much of America, is a tale of two cities. The experience of life—including a healthy, safe environment and access to good-quality health care—is vastly different depending on where you live and your demographic background. In the city of Wilmington, for example, ZIP codes that are just a few miles apart represent more than 20 years difference in life expectancy. This is not OK—it’s a sign that we have serious structural problems in our communities that are causing harm to people and making their lives shorter. Importantly, chopping $360 million out of Delaware’s hospital budgets, as House Bill 350 would do in year one, is not going to help this problem—it’s going to make it worse. And in doing so, it would ultimately make health care in Delaware more expensive—not less expensive. The key to lowering health care costs is to improve quality, access and equity Data show that about 5% of patients in the United States account for more than 50% of all health care costs. These are primarily patients who have complex and poorly managed chronic conditions that cause them to end up in the most expensive care settings—hospitals, operating rooms, emergency departments. The key to driving down health care costs is to improve quality and equity so that everyone is supported in achieving their best health, and these high users of the most expensive kinds of care are better supported in managing their health conditions such as diabetes or heart failure in the appropriate way. In doing so, they prevent the need for costly emergency or “rescue” care. Let’s do more—not less—of what we already know works Health care is not a one-size-fits-all industry. The delivery of care for patients across a diverse population requires multiple interventions at the same time. These interventions are designed not only to improve the quality of care but also to close the gap in terms of health care disparities. That’s important, because when we improve care and outcomes for the most vulnerable populations, we tend to get things right for everyone. One type of intervention is about doing exactly the right things for a patient based on the evidence of what will help—and doing nothing extra that will cause harm or generate additional costs without providing additional benefit. An example of this might be ensuring that every patient who has a heart attack gets a certain drug called a beta blocker right after their heart attack, and they receive clear guidance and support on the actions they must take to reduce their risk of a second heart attack, such as regular exercise and good nutrition. The second type of intervention is for the highest-risk populations. These are patients who live in poor communities where there are no gyms and no grocery stores, and people commonly have challenges with transportation and lack of access to resources that makes it difficult—sometimes impossible—to follow their plan for follow-up care. They lack access to high-nutrient food that reduces their risk of a second heart attack. They also live in areas where there are fewer health care providers compared to more affluent areas. These interventions tend to be very intensive and do not generate income for health systems; in fact, they require significant non-reimbursed investment, but they are necessary to keep our most vulnerable patients healthy. The medical community has developed interventions for these populations that are proven to work. A local example is the Delaware Food Pharmacy program, which connects at-risk patients with healthy food and supports their ability to prepare it. The program helps patients improve their overall health and effectively manage their chronic conditions so they can prevent an adverse event that would put them back in the hospital or emergency department. When we work together, we succeed We’ve seen incredible examples of how this work can be successful right here in Delaware. Delaware was the first state in the country to eliminate a racial disparity in colorectal cancer, and we did this by expanding cancer services, including making it easy for vulnerable people to get preventive cancer care and screenings. This is an incredible success story that continues to this day, and it was the result of thoughtful, detail-oriented partnerships among the state and the health care community. The work continues as we collaborate to reduce the impact and mortality of breast cancer in our state. Unfortunately, these kinds of interventions are the first thing to go when health care budgets get slashed, because they don’t generate revenue and are not self-sustaining. These kinds of activities need to be funded—either through grants or an external funder, or by the hospitals and health care systems. By narrowly focusing on cost, we risk losing the progress we have made Delaware House Bill 350, as it’s proposed, would cause harm in two ways: First, it would compromise our ability to invest in these kinds of interventions that work. Second, it increases the risk that higher-cost health services and programs that are disproportionately needed by people in vulnerable communities could become no longer available in Delaware. In states where the government has intervened in the name of cutting costs, like Vermont and Massachusetts, we see the consequences–less quality and reduced equitable access to much-needed services. House Bill 350 will widen the gap between those who have means and those who are more vulnerable. These changes will lead to increased disease burden on these populations. They will end up in the emergency room more and hospitalized more, which is by far the most expensive kind of care. That’s not what anyone wants—and it’s the opposite of what this bill was intended to accomplish. At this moment, in Delaware, we have an opportunity to put our state on a sustainable path to better health for all Delawareans. House Bill 350 is not that path. However, the discussion that House Bill 350 has started is something that we can build on by bringing together the stakeholders we need to collaborate with to solve these complicated problems. That includes Delaware’s government and legislators, the hospitals and health centers, the insurance, pharmacy and medical device industries, and most importantly, patients and the doctors who care for them. LeRoi Hicks, M.D., is the campus executive director for ChristianaCare, Wilmington Campus.
