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The evidence base, the tension between traditional and western medicine.

Traditional and alternative medicine are ubiquitous. Forty percent of American adults use at least one form of alternative medicine.  The WHO reports that traditional medicine constitutes around half of health care utilization in China and up to 80 percent of utilization in Sub-Saharan Africa.  Because it is pervasive, traditional medicine may have large public health impacts throughout the world.

Traditional and Western medicine are based on distinct conceptions of health and disease.  Unani Tibb (“Greek Medicine” in Arabic) is a common traditional medical system in South Asia.  It dates to the eleventh century and is based on the teachings of Hippocrates and Galen. In this system, health requires balance between the four humors of blood, mucus, yellow bile, and black bile, as well as the four qualities of heat, cold, moisture, and dryness.  Illnesses arise through imbalances in these forces, and Unani treatments seek to restore balance.  Ayurveda and Traditional Chinese Medicine similarly invoke the concept of balance.

By contrast, Western medicine relies in part on the germ theory of disease, which states that invisible microorganisms cause many diseases. The germ theory is a recent discovery that only gained traction in the 1880s through the work of Louis Pasteur and others.  While we take this model as given, it is not at all self-evident that invisible microbes exist and can cause illness.  For those with limited exposure to science, a traditional model of disease may seem plausible, while the notion of infection by invisible microbes may seem fanciful.

My recent paper with collaborators Asjad Naqvi and Wolf-Peter Schmidt examined whether Unani medical beliefs moderate the impact of hygiene information in rural Pakistan.  In this region, diarrhea is a leading cause of infant and child mortality and hygiene and sanitation are lacking.  There is a stark distinction between the Unani and Western approaches to diarrhea.  Unani medicine classifies diarrhea as a “hot” illness (a designation that is unrelated to physical temperature) and recommends that people restore balance by avoiding hot liquids and foods.  Since a mother has “hot” breast milk if she has been working in the fields, some Unani providers recommend withholding breast milk from infants with diarrhea.  This prescription directly contradicts the proven Western approach of oral rehydration therapy.

We evaluated a hygiene information intervention called Microbe Literacy.  This program provides basic hygiene education to participants in adult literacy classes.  To make their messages more credible, facilitators first used microscopes to show participants everyday bacteria from their environment.  We find that this innovative step increased the impact of subsequent hygiene messages, and that the program had meaningful and statistically significant impacts on hygiene and child health, even 16 months later.

I acknowledge that this finding only covers one health behavior (hygiene) in one context (rural Pakistan), and that the relationship between traditional and Western medicine may vary.  However there is almost no research that examines traditional-Western medical crowd out, regardless of the context. The extent of substitution surely depends on the illness, the traditional medical system, and other contextual factors.  This is a key topic in public health, and further work in this area is warranted.   Proponents of Western medicine should recognize that people may not always accept messages related to the germ theory at face value and take proactive steps to overcome skepticism in the community.

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• Study from Phoenix Children’s Research Institute Reveals New Way to Prevent Lung Cancer from Spreading

News Release

PHOENIX [April 25, 2024] – Research conducted at the Phoenix Children’s Research Institute at the University of Arizona College of Medicine — Phoenix shows normalizing cancer tumor vessels and alleviating low oxygen levels in the tumor microenvironment can improve the effectiveness of chemotherapy treatment in lung cancer, according to a paper published in EMBO Molecular Medicine .

This study, authored by Tanya Kalin, MD, PhD, vice chair of translational research for the Phoenix Children’s Center for Cancer and Blood Disorders and professor of Child Health at the University of Arizona College of Medicine — Phoenix, ”FOXF1 Promotes Vessel Normalization and Prevents Lung Cancer Progression Through FZD4, is a complete pivot from how researchers have historically studied cancer treatment by providing a solution that strengthens blood vessels feeding cancer tumors.

“Cancer research is often focused on ways to deplete cancer tumors of blood vessels and oxygen by basically starving the cancer cells to prevent tumor growth and metastasis, but it was shown this approach can make the tumor cells become even more aggressive and metastatic,” said Dr. Kalin. “Our study takes a completely different approach and instead of obliterating the tumor-associated blood vessels, we normalize and repair the tumor vessels by increasing the FOXF1 protein in endothelial cells, which, in turn, prevents lung cancer progression.”

Dr. Kalin, a renowned scientist focused on developing effective treatments for pediatric cancers, has spent the last few decades researching how to create a non-toxic small molecule inhibitor compound to kill cancer cells and developing tumor-cell-specific nanoparticles that deliver the inhibitor compound directly to cancer cells, blocking specific targeted proteins. This lung cancer study builds upon her years of research to develop a more targeted approach to cancer treatment. The insertion of the FOXF1 protein increases tumor vessel stability and stimulates nanoparticle delivery into the cancer-causing cells which destroys them from the inside with minimal chemotherapy.

“This is a promising study for future therapies in non-small cell lung cancer and other types of cancer and will hopefully change how we look at cancer treatment moving forward,” said Dr. Kalin.

Lung cancer is the leading cause of cancer-related mortality worldwide. Current treatment strategies include chemotherapy and/or radiotherapy, and surgery in the case of patients diagnosed with early-stage lung cancer. The 5-year survival rate of patients with advanced Non-Small Cell Lung Cancer (NSCLC) remains less than 20 percent, emphasizing a need to develop better treatment strategies. Interactions between the tumor-microenvironment and tumor cells play a crucial role in tumor progression and to this point traditional therapies have failed to improve overall survival of lung cancer patients, suggesting a deeper understanding of tumor-associated vascular biology is required.

“Every breakthrough in pediatric cancer research is cause for celebration, especially studies like Dr. Kalin’s that shed light on tumor microenvironments and stopping the spread of cancer,” said Stewart Goldman, MD, senior vice president of research for Phoenix Children’s and Sybil B. Harrington endowed chair and professor of Child Health at University of Arizona College of Medicine — Phoenix. “Dr. Kalin’s remarkable findings will have implications for non-small cell lung cancer, as well as many childhood cancers, hopefully changing cancer therapies in the near term and I believe this research will be one of the most cited cancer research studies for years to come.”

In March, Phoenix Children’s released another study, “CRISPR/Cas9 Genome Editing Allows Generation of the Mouse Lung in a Rat,” that focuses on finding an innovative solution for babies born with chronic lung diseases caused by either prematurity or severe genetic conditions.

The Phoenix Children's Research Institute at the University of Arizona College of Medicine — Phoenix launched in May 2023, formalizing a longstanding research collaboration between the health system and the University of Arizona College of Medicine — Phoenix. The Research Institute includes more than 700 active studies, 640 research investigators and 90 research staff members including research scientists, associates, biostatisticians, pharmacists, nurses and coordinators. Scientists engage in research across multiple clinical disciplines including cancer , neurology , cardiology , pulmonology and more.

Phoenix Children’s Names New Chief of Neurosurgery April 24, 2024

Phoenix Children’s Unveils “Wonder And Wander,” a 407-Foot Mural to Advance Hope and Healing for Patient Families April 18, 2024

Dr. Ashish S. Patel Named Physician-in-Chief at Phoenix Children’s April 15, 2024

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• Western Medicine: An...

Western Medicine: An Illustrated History

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• Ann Dally , research fellow, Wellcome Institute for the History of Medicine

Ed Irvine Loudon Oxford University Press, £25, pp 346 ISBN 0 19 820509 0

The history of medicine, new style, is becoming increasingly popular. Run by historians more than by doctors, it banishes antiquarianism, “great discoveries,” “great men,” and professional self satisfaction. It welcomes all aspects of medicine in historical context. As a result, there has been a recent plethora of large, beautifully illustrated books written by experts with the aim of giving a bird's eye view. This is one such book and is of exceptionally high quality with many wonderful illustrations.

There has clearly been a tight overall view of what was needed and who was to do it. It was not surprising to hear that the plan was organised at a lunch for the contributors at All Soul's College, Oxford. Was it this that provided the atmosphere of excellence? Another delightful feature is the prominence of the visual. The art historian Martin Kemp is the author of the first chapter, “Art and Visual Representation,” which explores the nature, purpose, and impact of visual imagery on medicine. Kemp points out that the visual legacy of Western medicine is richer than that for any other scientific or technical activity. This is amply demonstrated throughout the book by a huge variety of illustrations, from excellent reproductions of great paintings to drawings of instruments, photographs of modern childbirth, drawings from Gray's Anatomy , keyhole surgery, micrographs of the AIDS virus, and much else—an irresistible combination.

Only five of the 20 authors are medically qualified, and only two of these (including the editor, who is also a distinguished historian) have had extensive clinical experience, which sometimes shows. Two or three more were trained as scientists. The rest are historians in the widest sense. They cover geography, philosophy, history of science, social policy, and history of art—a good, stimulating mix, hard to put down.

Such a book cannot cover every aspect of the subject. In a further edition I would like to read more about the history of doctor-patient relationships, the development of physical examination and physical signs, iatrogenic disease (a modern scourge), and, of course, the new craze of evidence based medicine. A chapter on the development, importance, and influence of medical journals would also be good. One of the authors is Stephen Lock, former editor of the BMJ , but he writes on another topic, contributing a masterly account of modern medicine and its triumphs and discontents, one of the best chapters in the book.

Rating: ***

Studying the role of inflammation in heart disease

• Feinberg School of Medicine

Northwestern Medicine scientists have been selected to lead one of only three research centers nationally as part of a $15 million American Heart Association (AHA) research initiative studying the role of inflammation in heart disease.

While inflammation is critical for mounting immune responses against pathogens or injuries, inflammatory dysregulation can fuel numerous diseases, including those in the heart.

“Fundamentally, we know that inflammation is an immune response to something, we understand the ‘something’ to a reasonable degree and we’re starting to understand the immune response better,” said Dr. Matthew Feinstein , associate professor of cardiology at Northwestern University Feinberg School of Medicine, who will direct one research center in the collaboration. “But there’s so much more work we need to do to understand the diversity of human immune responses that can lead some people to have inflammation go off the rails and some people to actually be able to resolve that inflammation and do it in a way that doesn’t lead to disease development.”

The four-year awards, funded by the AHA’s Strategically Focused Research Network (SFRN) on Inflammation in Cardiac and Neurovascular Disease, started April 1.

Partnering with Chicago State University, Northwestern’s research center will undertake three different projects focused on understanding inflammatory responses and how to treat heart disease caused by inflammation, specifically in patients with heart failure with preserved ejection fraction (HFpEF).

HFpEF is marked by excessive inflammation and accounts for more than half of all heart failure cases in the U.S. The condition also carries a significant public health burden: 50% of people diagnosed with HFpEF die within five years, according to the AHA.

Northwestern’s research initiatives will focus on immune cells, which regulate inflammation in the body, and how the cells are affected by stressors. Investigators will also analyze existing and novel approaches to modulating metabolism and immune cell responses in HFpEF with the ultimate goal of targeting inflammation to address the disease.

“We’ll do this by bringing together patient-centered approaches and experimental model systems, all coalescing around the question of ‘What is turning inflammation on and off in the setting of cardiometabolic risk factors and HFpEF?’” Feinstein said. “The goal is that this knowledge will inform approaches that modulate harmful, unresolving inflammation to curb cardiometabolic disease and HFpEF.”

The AHA funds SFRNs as part of its mission to advance cardiovascular health for all. Research teams apply for the program’s four-year grants with novel and innovative ideas to better understand cardiovascular diseases impacted by each research network’s focus, the latest of which is inflammation.

“Often times, the way we investigate inflammation in the heart and vascular disease can be really siloed,” Feinstein said. “We’re thrilled to start to break down some of these walls to understand fundamental features and mechanisms of cardiometabolic inflammation, and to do so in a patient-relevant way.”

Additional Feinberg faculty serving as principal investigators on projects in the Feinberg-based center include Dr. Sanjiv Shah , the Neil J. Stone, MD, professor of cardiology; Edward Thorp , the Frederick Robert Zeit Professor of Pathology; and Kiarri Kershaw , associate professor of preventive medicine (epidemiology).

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Driving Innovations in Biostatistics with Denise Scholtens, PhD

“I'm continually surprised by new data types. I think that we will see the emergence of a whole new kind of technology that we probably can't even envision five years from now…When I think about where the field has come over the past 20 years, it's just phenomenal.”  —  Denise Scholtens, PhD  

• Director, Northwestern University Data Analysis and Coordinating Center (NUDACC)  
• Chief of Biostatistics in the Department of Preventive Medicine  
• Professor of Preventive Medicine in the Division of Biostatistics and of Neurological Surgery  
• Member of Northwestern University Clinical and Translational Sciences Institute (NUCATS)  
• Member of the Robert H. Lurie Comprehensive Cancer Center  

Episode Notes 

Since arriving at Feinberg in 2004, Scholtens has played a central role in the dramatic expansion of biostatistics at the medical school. Now the Director of NUDACC, Scholtens brings her expertise and leadership to large-scale, multicenter studies that can lead to clinical and public health practice decision-making.    

• After discovering her love of statistics as a high school math teacher, Scholtens studied bioinformatics in a PhD program before arriving at Feinberg in 2004.  
• Feinberg’s commitment to biostatistics has grown substantially in recent decades. Scholtens was only one of five biostatisticians when she arrived. Now she is part of a division with almost 50 people.  
• She says being a good biostatistician requires curiosity about other people’s work, knowing what questions to ask and tenacity to understand subtitles of so much data.   
• At NUDACC, Scholtens and her colleagues specialize in large-scale, multicenter prospective studies and clinical trials that lead to clinical or public health practice decision-making. They operate at the executive level and oversee all aspects of the study design.  
• Currently, Scholtens is involved with the launch of a large study, along with The Ohio State University, that received a $14 million grant to look at the effectiveness of aspirin in the prevention of hypertensive disorders in pregnancy.  
• Scholtens first started her work in data coordinating through the Hyperglycemia Adverse Pregnancy Outcome (HAPO) study, which looked at 25,000 pregnant individuals. This led to a continued interest in fetal and maternal health.   
• When it comes to supportive working environments, Scholtens celebrates the culture at Feinberg, and especially her division in biostatistics, for being collaborative as well as genuinely supportive of each other’s projects. She attributes this to strong leadership which established a culture with these guiding principles.   

Additional Reading  

• Read more about the ASPIRIN trial and other projects taking place at NUDACC   
• Discover a study linking mothers’ obesity-related genes to babies’ birth weight, which Scholtens worked in through the HAPO study   
• Browse all of Scholtens recent publications 

Recorded on February 21, 2024.

Continuing Medical Education Credit

Physicians who listen to this podcast may claim continuing medical education credit after listening to an episode of this program..

Target Audience

Academic/Research, Multiple specialties

Learning Objectives

At the conclusion of this activity, participants will be able to:

• Identify the research interests and initiatives of Feinberg faculty.
• Discuss new updates in clinical and translational research.

Accreditation Statement

The Northwestern University Feinberg School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement

The Northwestern University Feinberg School of Medicine designates this Enduring Material for a maximum of 0.50  AMA PRA Category 1 Credit(s)™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Board of Surgery Continuous Certification Program

Successful completion of this CME activity enables the learner to earn credit toward the CME requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit.

All the relevant financial relationships for these individuals have been mitigated.

Disclosure Statement

Denise Scholtens, PhD, has nothing to disclose.  Course director, Robert Rosa, MD, has nothing to disclose. Planning committee member, Erin Spain, has nothing to disclose.  FSM’s CME Leadership, Review Committee, and Staff have no relevant financial relationships with ineligible companies to disclose.

Read the Full Transcript

[00:00:00] Erin Spain, MS: This is Breakthroughs, a podcast from Northwestern University Feinberg School of Medicine. I'm Erin Spain, host of the show. Northwestern University Feinberg School of Medicine is home to a team of premier faculty and staff biostatisticians, who are the driving force of data analytic innovation and excellence here. Today, we are talking with Dr. Denise Scholtens, a leader in biostatistics at Northwestern, about the growing importance of the field, and how she leverages her skills to collaborate on several projects in Maternal and Fetal Health. She is the Director of the Northwestern University Data Analysis and Coordinating Center, NUDACC, and Chief of Biostatistics in the Department of Preventive Medicine, as well as Professor of Preventive Medicine and Neurological Surgery. Welcome to the show.  

[00:01:02] Denise Scholtens, PhD: Thank you so much.  

[00:01:02] Erin Spain, MS: So you have said in the past that you were drawn to this field of biostatistics because you're interested in both math and medicine, but not interested in becoming a clinician. Tell me about your path into the field and to Northwestern.  

[00:01:17] Denise Scholtens, PhD: You're right. I have always been interested in both math and medicine. I knew I did not want to be involved in clinical care. Originally, fresh out of college, I was a math major and I taught high school math for a couple of years. I really enjoyed that, loved the kids, loved the teaching parts of things. Interestingly enough, my department chair at the time assigned me to teach probability and statistics to high school seniors. I had never taken a statistics course before, so I was about a week ahead of them in our classes and found that I just really enjoyed the discipline. So as much as I loved teaching, I did decide to go ahead and invest in this particular new area that I had found and I really enjoyed. So I wanted to figure out how I could engage in the field of statistics. Decided to see, you know, exactly how studying statistics could be applied to medicine. At the time, Google was brand new. So I literally typed in the two words math and medicine to see what would come up. And the discipline of biostatistics is what Google generated. And so here I am, I applied to grad school and it's been a great fit for me.  

[00:02:23] Erin Spain, MS: Oh, that's fantastic. So you went on to get a PhD, and then you came to Northwestern in 2004. And so tell me a little bit about the field then and how it's changed so dramatically since.  

[00:02:36] Denise Scholtens, PhD: So yes, I started here at Northwestern in 2004, just a few months after I had defended my thesis. At the time there was really an emerging field of study called bioinformatics. So I wrote my thesis in the space of genomics data analysis with what at the time was a brand new technology, microarrays. This was the first way we could measure gene transcription at a high throughput level. So I did my thesis work in that space. I studied at an institution with a lot of strengths and very classical statistics. So things that we think of in biostatistics like clinical trial design, observational study analysis, things like that. So I had really classic biostatistics training and then complimented that with sort of these emerging methods with these high dimensional data types. So I came to Northwestern here and I sort of felt like I lived in two worlds. I had sort of classic biostat clinical trials, which were certainly, you know, happening here. And, that work was thriving here at Northwestern, but I had this kind of new skillset, and I just didn't quite know how to bring the two together. That was obviously a long time ago, 20 years ago. Now we think of personalized medicine and genomic indicators for treatment and, you know, there's a whole variety of omics data variations on the theme that are closely integrated with clinical and population level health research. So there's no longer any confusion for me about how those two things come together. You know, they're two disciplines that very nicely complement each other. But yeah, I think that does speak to how the field has changed, you know, these sort of classic biostatistics methods are really nicely blended with a lot of high dimensional data types. And it's been fun to be a part of that.  

[00:04:17] Erin Spain, MS: There were only a handful of folks like you at Northwestern at the time. Tell me about now and the demand for folks with your skill set.  

[00:04:26] Denise Scholtens, PhD: When I came to Northwestern, I was one of a very small handful of biostatistics faculty. There were five of us. We were not even called a division of biostatistics. We were just here as the Department of Preventive Medicine. And a lot of the work we did was really very tightly integrated with the epidemiologists here in our department and we still do a lot of that for sure. There was also some work going on with the Cancer Center here at Northwestern. But yeah, a pretty small group of us, who has sort of a selected set of collaborations. You know, I contrast that now to our current division of biostatistics where we are over 20s, pushing 25, depending on exactly how you want to count. Hoping to bring a couple of new faculty on board this calendar year. We have a staff of about 25 statistical analysts. And database managers and programmers. So you know, when I came there were five faculty members and I think two master's level staff. We are now pushing, you know, pushing 50 people in our division here so it's a really thriving group.  

[00:05:26] Erin Spain, MS: in your opinion, what makes a good biostatistician? Do you have to have a little bit of a tough skin to be in this field?  

Denise Scholtens, PhD: I do think it's a unique person who wants to be a biostatistician. There are a variety of traits that can lead to success in this space. First of all, I think it's helpful to be wildly curious about somebody else's work. To be an excellent collaborative biostatistician, you have to be able to learn the language of another discipline. So some other clinical specialty or public health application. Another trait that makes a biostatistician successful is to be able to ask the right questions about data that will be collected or already have been collected. So understanding the subtleties there, the study design components that lead to why we have the data that we have. You know, a lot of our data, you could think of it in a simple flat file, right? Like a Microsoft Excel file with rows and columns. That certainly happens a lot, but there are a lot of incredibly innovative data types out there: wearables technology, imaging data, all kinds of high dimensional data. So I think a tenacity to understand all of the subtleties of those data and to be able to ask the right questions. And then I think for a biostatistician at a medical school like ours, being able to blend those two things, so understanding what the data are and what you have to work with and what you're heading toward, but then also facilitating the translation of those analytic findings for the audience that really wants to understand them. So for the clinicians, for the patients, for participants and the population that the findings would apply to.   

Erin Spain, MS: It must feel good, though, in those situations where you are able to help uncover something to improve a study or a trial.  

[00:07:07] Denise Scholtens, PhD: It really does. This is a job that's easy to get out of bed for in the morning. There's a lot of really good things that happen here. It's exciting to know that the work we do could impact clinical practice, could impact public health practice. I think in any job, you know, you can sometimes get bogged down by the amount of work or the difficulty of the work or the back and forth with team members. There's just sort of all of the day to day grind, but to be able to take a step back and remember the actual people who are affected by our own little niche in this world. It's an incredibly helpful and motivating practice that I often keep to remember exactly why I'm doing what I'm doing and who I'm doing it for.  

[00:07:50] Erin Spain, MS: Well, and another important part of your work is that you are a leader. You are leading the center, NUDACC, that you mentioned, Northwestern University Data Analysis and Coordinating Center. Now, this has been open for about five years. Tell me about the center and why it's so crucial to the future of the field.  

[00:08:08] Denise Scholtens, PhD: We specialize at NUDACC in large scale, multicenter prospective studies. So these are the clinical trials or the observational studies that often, most conclusively, lead to clinical or public health practice decision making. We focus specifically on multicenter work. Because it requires a lot of central coordination and we've specifically built up our NUDACC capacity to handle these multi center investigations where we have a centralized database, we have centralized and streamlined data quality assurance pipelines. We can help with central team leadership and organization for large scale networks. So we have specifically focused on those areas. There's a whole lot of project management and regulatory expertise that we have to complement our data analytics strengths as well. I think my favorite part of participating in these studies is we get involved at the very beginning. We are involved in executive level planning of these studies. We oversee all components of study design. We are intimately involved in the development of the data capture systems. And in the QA of it. We do all of this work on the front end so that we get all of the fun at the end with the statistics and can analyze data that we know are scientifically sound, are well collected, and can lead to, you know, really helpful scientific conclusions.  

[00:09:33] Erin Spain, MS: Tell me about that synergy between the clinicians and the other investigators that you're working with on these projects.  

[00:09:41] Denise Scholtens, PhD: It is always exciting, often entertaining. Huge range of scientific opinion and expertise and points of view, all of which are very valid and very well informed. All of the discussion that could go into designing and launching a study, it's just phenomenally interesting and trying to navigate all of that and help bring teams to consensus in terms of what is scientifically most relevant, what's going to be most impactful, what is possible given the logistical strengths. Taking all of these well informed, valid, scientific points of view and being a part of the team that helps integrate them all toward a cohesive study design and a well executed study. That's a unique part of the challenge that we face here at NUDACC, but an incredibly rewarding one. It's also such an honor and a gift to be able to work with such a uniformly gifted set of individuals. Just the clinical researchers who devote themselves to these kinds of studies are incredibly generous, incredibly thoughtful and have such care for their patients and the individuals that they serve, that to be able to sit with them and think about the next steps for a great study is a really unique privilege.  

[00:10:51] Erin Spain, MS: How unique is a center like this at a medical school?  

[00:10:55] Denise Scholtens, PhD: It's fairly unique to have a center like this at a medical school. Most of the premier medical research institutions do have some level of data coordinating center capacity. We're certainly working toward trying to be one of the nation's best, absolutely, and build up our capacity for doing so. I'm actually currently a part of a group of data coordinating centers where it's sort of a grassroots effort right now to organize ourselves and come up with, you know, some unified statements around the gaps that we see in our work, the challenges that we face strategizing together to improve our own work and to potentially contribute to each other's work. I think maybe the early beginnings of a new professional organization for data coordinating centers. We have a meeting coming up of about, I think it's 12 to 15 different institutions, academic research institutions, specifically medical schools that have centers like ours to try to talk through our common pain points and also celebrate our common victories.  

[00:11:51] Erin Spain, MS: I want to shift gears a little bit to talk about some of your research collaborations, many of which focus on maternal and fetal health and pregnancy. You're now involved with a study with folks at the Ohio State University that received a 14 million grant looking at the effectiveness of aspirin in the prevention of hypertensive disorders in pregnancy. Tell me about this work.  

[00:12:14] Denise Scholtens, PhD: Yes, this is called the aspirin study. I suppose not a very creative name, but a very appropriate one. What we'll be doing in this study is looking at two different doses of aspirin for trying to prevent maternal hypertensive disorders of pregnancy in women who are considered at high risk for these disorders. This is a huge study. Our goal is to enroll 10,742 participants. This will take place at 11 different centers across the nation. And yes, we at NUDACC will serve as the data coordinating center here, and we are partnering with the Ohio State University who will house the clinical coordinating center. So this study is designed to look at two different doses to see which is more effective at preventing hypertensive disorders of pregnancy. So that would include gestational hypertension and preeclampsia. What's really unique about this study and the reason that it is so large is that it is specifically funded to look at what's called a heterogeneity of treatment effect. What that is is a difference in the effectiveness of aspirin in preventing maternal hypertensive disorders, according to different subgroups of women. We'll specifically have sufficient statistical power to test for differences in treatment effectiveness. And we have some high priority subgroups that we'll be looking at. One is a self-identified race. There's been a noted disparity in maternal hypertensive disorders, for individuals who self identify according to different races. And so we will be powered to see if aspirin has comparable effectiveness and hopefully even better effectiveness for the groups who really need it, to bring those rates closer to equity which is, you know, certainly something we would very strongly desire to see. We'll also be able to look at subgroups of women according to obesity, according to maternal age at pregnancy, according to the start time of aspirin when aspirin use is initiated during pregnancy. So that's why the trial is so huge. For a statistician, the statisticians out there who might be listening, this is powered on a statistical interaction term, which doesn't happen very often. So it's exciting that the trial is funded in that way.  

[00:14:27] Erin Spain, MS: Tell me a little bit more about this and how your specific skills are going to be utilized in this study.  

[00:14:32] Denise Scholtens, PhD: Well, there are three biostatistics faculty here at Northwestern involved in this. So we're definitely dividing and conquering. Right now, we're planning this study and starting to stand it up. So we're developing our statistical analysis plans. We're developing the database. We are developing our randomization modules. So this is the piece of the study where participants are randomized to which dose of aspirin they're going to receive. Because of all of the subgroups that we're planning to study, we need to make especially sure that the assignments of which dose of aspirin are balanced within and across all of those subgroups. So we're going to be using some adaptive randomization techniques to ensure that that balance is there. So there's some fun statistical and computer programming innovation that will be applied to accomplish those things. So right now, there are usually two phases of a study that are really busy for us. That's starting to study up and that's where we are. And so yes, it is very busy for us right now. And then at the end, you know, in five years or so, once recruitment is over, then we analyze all the data,  

[00:15:36] Erin Spain, MS: Are there any guidelines out there right now about the use of aspirin in pregnancy. What do you hope that this could accomplish?  

 Prescribing aspirin use for the prevention of hypertension during pregnancy is not uncommon at all. That is actually fairly routinely done, but that it's not outcomes based in terms of which dosage is most effective. So 81 milligrams versus 162 milligrams. That's what we will be evaluating. And my understanding is that clinicians prescribe whatever they think is better, and I'm sure those opinions are very well informed but there is very little outcome based evidence for this in this particular population that we'll be studying. So that would be the goal here, would be to hopefully very conclusively say, depending on the rates of the hypertensive disorders that we see in our study, which of the two doses of aspirin is more effective. Importantly, we will also be tracking any side effects of taking aspirin. And so that's also very much often a part of the evaluation of You know, taking a, taking a drug, right, is how safe is it? So we'll be tracking that very closely as well. Another unique part of this study is that we will be looking at factors that help explain aspirin adherence. So we are going to recommend that participants take their dose of aspirin daily. We don't necessarily expect that's always going to happen, so we are going to measure how much of their prescribed dose they are actually taking and then look at, you know, factors that contribute to that. So be they, you know, social determinants of health or a variety of other things that we'll investigate to try to understand aspirin adherence, and then also model the way in which that adherence could have affected outcomes.  

Erin Spain, MS: This is not the first study that you've worked on involving maternal and fetal health. Tell me about your interest in this particular area, this particular field, and some of the other work that you've done.  

[00:17:31] Denise Scholtens, PhD: So I actually first got my start in data coordinating work through the HAPO study. HAPO stands for Hyperglycemia Adverse Pregnancy Outcome. That study was started here at Northwestern before I arrived. Actually recruitment to the study occurred between 2000 and 2006. Northwestern served as the central coordinating center for that study. It was an international study of 25,000 pregnant individuals who were recruited and then outcomes were evaluated both in moms and newborns. When I was about mid career here, all the babies that were born as a part of HAPO were early teenagers. And so we conducted a follow up study on the HAPO cohort. So that's really when I got involved. It was my first introduction to being a part of a coordinating center. As I got into it, though, I saw the beauty of digging into all of these details for a huge study like this and then saw these incredible resources that were accumulated through the conduct of such a large study. So the data from the study itself is, was of course, a huge resource. But then also we have all of these different samples that sit in a biorepository, right? So like usually blood sample collection is a big part of a study like this. So all these really fun ancillary studies could spin off of the HAPO study. So we did some genomics work. We did some metabolomics work. We've integrated the two and what's called integrated omics. So, you know, my work in this space really started in the HAPO study. And I have tremendously enjoyed integrating these high dimensional data types that have come from these really rich data resources that have all, you know, resulted because of this huge multicenter longitudinal study. So I kind of accidentally fell into the space of maternal and fetal health, to be honest. But I just became phenomenally interested in it and it's been a great place.  

[00:19:24] Erin Spain, MS: Would you say that this is also a population that hasn't always been studied very much in biomedical science?  

[00:19:32] Denise Scholtens, PhD: I think that that is true, for sure. There are some unique vulnerabilities, right, for a pregnant individual and for the fetus, right, and in that situation. You know, the vast majority of what we do is really only pertaining to the pregnant participant but, you know, there are certainly fetal outcomes, newborn outcomes. And so, I think conducting research in this particular population is a unique opportunity and there are components of it that need to be treated with special care given sort of this unique phase of human development and this unique phase of life.  

[00:20:03] Erin Spain, MS: So, as data generation just really continues to explode, and technology is advancing so fast, faster than ever, where do you see this field evolving, the field of biostatistics, where do you see it going in the next five to ten years?  

[00:20:19] Denise Scholtens, PhD: That's a great question. I think all I can really tell you is that I'm continually surprised by new data types. I think that we will see an emergence of a whole new kind of technology that we probably can't even envision five years from now. And I think that the fun part about being a biostatistician is seeing what's happening and then trying to wrap your mind around the possibilities and the actual nature of the data that are collected. You know, I think back to 2004 and this whole high throughput space just felt so big. You know, we could look at gene transcription across the genome using one technology. And we could only look at one dimension of it. Right now it just seems so basic. When I think about where the field has come over the past 20 years, it's just phenomenal. I think we're seeing a similar emergence of the scale and the type of data in the imaging space and in the wearable space, with EHR data, just. You know, all these different technologies for capturing, capturing things that we just never even conceived of before. I do hope that we continue to emphasize making meaningful and translatable conclusions from these data. So actionable conclusions that can impact the way that we care for others around us. I do hope that remains a guiding principle in all that we do.  

[00:21:39] Erin Spain, MS: Why is Northwestern Medicine and Northwestern Feinberg School of Medicine such a supportive environment to pursue this type of work?  

[00:21:47] Denise Scholtens, PhD: That's a wonderful question and one, honestly, that faculty candidates often ask me. When we bring faculty candidates in to visit here at Northwestern, they immediately pick up on the fact that we are a collaborative group of individuals who are for each other. Who want to see each other succeed, who are happy to share the things that we know and support each other's work, and support each other's research, and help strategize around the things that we want to accomplish. There is a strong culture here, at least in my department and in my division that I've really loved that continues to persist around really genuinely collaborating and genuinely sharing lessons learned and genuinely supporting each other as we move toward common goals. We've had some really strong, generous leadership who has helped us to get there and has helped create a culture where those are the guiding principles. In my leadership role is certainly something that I strive to maintain. Really hope that's true. I'm sure I don't do it perfectly but that's absolutely something I want to see accomplished here in the division and in NUDACC for sure.  

[00:22:50] Erin Spain, MS: Well, thank you so much for coming on the show and telling us about your path here to Northwestern and all of the exciting work that we can look forward to in the coming years.  

[00:22:59] Denise Scholtens, PhD: Thank you so much for having me. I've really enjoyed this.  

[00:23:01] Erin Spain, MS: You can listen to shows from the Northwestern Medicine Podcast Network to hear more about the latest developments in medical research, health care, and medical education. Leaders from across specialties speak to topics ranging from basic science to global health to simulation education. Learn more at feinberg. northwestern.edu/podcasts.  

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• v.18; 2023 Feb

Ethical principles of traditional Indigenous medicine to guide western psychedelic research and practice

Yuria celidwen.

a University of California, Berkeley, CA, USA

Nicole Redvers

b Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada

c Arctic Indigenous Wellness Foundation, Yellowknife, NT, Canada

Cicilia Githaiga

d University of Nairobi, Nairobi, Kenya

Janeth Calambás

e Universidad Distrital Francisco José de Caldas, Bogotá, Colombia

Karen Añaños

f University of Granada, Granada, Spain

Miguel Evanjuanoy Chindoy

g Unión de Médicos Indígenas Yageceros de La Amazonía Colombiana, Colombia

Riccardo Vitale

Juan nelson rojas.

h Pull Together Now, USA

i Pipil Kakawira Indigenous Council of Firekeepers and Healers, El Salvador

Delores Mondragón

j University of California Santa Barbara, CA, USA

Yuniur Vázquez Rosalío

k Wixárika Ceremonial Center “Kuruxi Manuwe” of the Wixárika Regional Council in Defense of Wirikuta, Mexico

Angelina Sacbajá

l Nimalaxik, Association of Traditional Mayan Medicine, Guatemala

Associated Data

The resurgence of Western psychedelic research and practice has led to increasing concerns from many Indigenous Nations regarding cultural appropriation, lack of recognition of the sacred cultural positioning of these medicines, exclusionary practices in research and praxis, and patenting of traditional medicines. Indigenous voices and leadership have been notably absent from the Western psychedelic field currently widely represented by Westerners. An Indigenous-led globally represented group of practitioners, activists, scholars, lawyers, and human rights defenders came together with the purpose of formulating a set of ethical guidelines concerning traditional Indigenous medicines current use in Western psychedelic research and practice. A global Indigenous consensus process of knowledge-gathering was engaged which identified eight interconnected ethical principles, including: Reverence, Respect, Responsibility, Relevance, Regulation, Reparation, Restoration, and Reconciliation. A summary of the work is presented here with suggested ethical actions for moving forward within Western psychedelic research and practice spaces.

Introduction

Western psychedelic research is an emerging and controversial research and praxis within psychiatric medicine 1 , 2 , 3 , 4 and the neuroscientific fields. 5 Some randomized controlled trials have supported the efficacy of the use of certain Spirit medicines (aka. psychedelics) such as psilocybin in the treatment of depression and cancer-related anxiety, 5 , 6 , 7 , 8 with ayahuasca's treatment of psychiatric disorders, for example, being preliminary. 4 Yet, the general utilization of psychedelics is growing in acceptance with more than 30 million estimated psychedelic users in the United States (US) alone. 9 As of 2022, there were 367 registered clinical studies on psychedelics, 10 with an increasing number of cities and states in the U.S. legalizing their use. 11 The economic profits alone of the psychedelic industry is expected to grow to 6.85 billion by 2027. 12

The resurgence of the Western psychedelic movement has, however, led to increasing concerns from many Indigenous Nations regarding the cultural appropriation of their traditional medicines, a lack of recognition of the sacred positioning of these medicines within their communities and cultures, exclusionary practices in research and scale up endeavours, and the threat to their intellectual property rights with patents of traditional Indigenous medicines. 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 Indigenous Peoples’ voices and leadership have been notably absent from Western psychedelic research and psychedelic-assisted therapy spaces, with the field currently being widely represented by Western peoples. When Indigenous voices have been engaged, their presence has often been more symbolic, with little distributed benefit going back to their communities. 14 , 15 For example, despite this growing multi billion-dollar industry, there is little evidence of any potential health or economic return to Indigenous communities, who make up 6% of the world population, yet 30% of the extremely poor, 22 and live on average 20 years less than non-Indigenous Peoples. 23 , 24 These disparities are further exemplified by the knowledge that Western psychedelic practitioners and facilitators can reach average earnings of $10,500 per service event, 25 compared to Indigenous medicine practitioners who may earn between $2 to $150 for their services in their communities of origin. 26

Indigenous policy considerations

In 2001, a report supported by the World Health Organization Traditional Medicine Program (WHO TRM) determined that a total of 122 in-use drug compounds were being used in Western medicine at the time, and 80% of these compounds were used for the same (or related) purpose as their original traditional medicine use. 27 Yet, many Indigenous medicine systems around the world are still often given the back seat when it comes to both acknowledgement and practice within the conventional medical-care setting. 28 Free, prior, and informed consent (FPIC) is a specific right that pertains to Indigenous Peoples, 29 additionally recognized in the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP). 30 FPIC has not been historically honored or understood in the context of the application of the rights of Indigenous Peoples within Western medical research and praxis, including within the context of appropriation of traditional medicines. 31

Traditional Indigenous medicine is currently far from being widely protected by law. As of 2022, only the constitutions of Bolivia (Art. 42), 32 and Ecuador (Art. 57) 33 include regulation specific to Indigenous traditional medicine. Other relevant frameworks that mention Indigenous rights to the use and development of their traditional medicines and related practices are the ILO Convention No. 169 (Art. 25.2), 34 UNDRIP (Arts. 24 and 31), 30 the American Declaration on the Rights of Indigenous Peoples (Art. 13; Art. 18; Art. 28), 35 the Convention on Biological Diversity (CBD) (Art. 8 [j], 16, and Annex 1) 36 and its Nagoya protocol on Access and benefit-sharing (Art. 7 and Art. 12), 36 the Sharm El-Sheikh Declaration (2018), 37 UNESCO's Local and Indigenous Knowledge Systems Program (LINKS), 38 and UNESCO's policy on engaging with Indigenous Peoples. 39 In addition, the United Nations Permanent Forum on Indigenous Issues (UNPFII) issued a report on Indigenous Traditional Knowledge in 2012, recommending the inclusion of the protection of Indigenous intellectual property to the World International Intellectual Property Organization (WIPO). 40 Over the years, the topic of intellectual property has been included in UNPFII sessions, with the most recent in its twenty-first session held in 2022. 41 Yet, despite the established legal frameworks noted here, none specifically addresses Indigenous traditional medicine's rapid commodification and commercialization in the West in certain fields of practice. These legal frameworks noted also don't address contexts where the countries of research and practice are not signatories to the above noted mechanisms (e.g., the US is not a signatory to the CBD and therefore also not party to the Nagoya protocol on Access and benefit-sharing).

Indigenous worldview and praxis

Indigenous Peoples' worldviews currently have very little explicit attention, presence, and focus within Western psychedelic research and assisted therapies. Furthermore, the decontextualized appropriation of Indigenous traditional medicines in the context of psychedelics is arguably detrimental to Indigenous health and Land rights through unauthorized research and drug development. 42 , 43 Appropriation is additionally driving rainforest deforestation due to increasing global demands for the use of plant-derived psychedelics. 44 , 45 Therefore, there is increasingly a premise and an acute need for actioned ethical responsibility within psychedelic research and practice communities to ensure Indigenous rights are upheld when it comes to the determination and usage of Indigenous Peoples’ own traditional knowledges and practices.

From the Indigenous community context, the preservation of both tangible (e.g., material property) and intangible (e.g., intellectual property, cultural skills and traditions, performing arts, ceremonies) 46 traditional medicines and practices are fundamental for the transmission of cultural identity and survival. Indigenous healing traditions themselves orient their application on what is termed ‘relationality,’ which is the understanding that,

“… human lives are interdependent with and contingent on living in ethical relations with other people, with our ancestors, with plants and animals, and with the natural world overall. Indigenous systems of relationality are the heartbeat of Indigenous existence. They help to illuminate approaches to physical, intellectual, emotional, and spiritual health.” 47

This relational system is based on physical, emotional, cognitive, and spiritual qualities that make Indigenous systems interdependent, participatory, and ecologically-based. 48 Indigenous collective identity is thus rooted in a sense of gratitude, awe, and reverence with a firm responsibility and sense of stewardship towards all interconnected ecosystems and life cycles. 48 , 49 This collective identity is additionally bound by an utmost respect for Mother Earth and all human, other-than-human, and environmental relationships. 49 , 50 , 51

It is additionally important to highlight that this relational system is inclusive of psychedelic medicines; however, the use of the term ‘psychedelic’ (“manifesting the mind”), is very much a Western-based individualistic term and not an Indigenous one. Despite this, the term ‘psychedelic’ is applied consistently in this Personal View to ensure understanding for Western clinicians and audiences. Indigenous Nations have their own traditional-language names for these psychedelic medicines, which can sometimes be referred to in the English language as Spirit medicine, sacred medicines, sacramental medicines, or traditional medicines. This Personal View also specifically references ‘traditional Indigenous medicine’ throughout this consensus process to differentiate Indigenous medicine practices from other more well-known traditional medicine systems such as Traditional Chinese Medicine (TCM).

Indigenous consensus process

Despite the inherent complexities surrounding psychedelic research and practice (including its standing in Western legislation), the overarching goal of this Personal View is to share the results of a consensus process that brought together a breath of leadership across fields of Indigenous and intercultural health; the defense of the rights of Indigenous Peoples and the Rights of Mother Earth; Indigenous spiritual traditions; and governance and community advocacy at regional, national, and international levels. The Indigenous-led group gathered with the purpose of formulating a set of ethical guidelines concerning traditional Indigenous medicines use in Western psychedelic research and practice. This is the first time to our knowledge that a globally represented Indigenous led group has been brought together with the purpose of engaging directly with the psychiatric and research community on this topic through formal scholarship.

An adapted consensus development panel was therefore used to establish firm guidance on the ethical standards needed for the engagement with Indigenous Peoples and their traditional medicines within psychedelic research and practice. The consensus development panel was adapted following methods described in detail by Redvers et al., 49 which platforms and centres Indigenous ways of knowledge-gathering and sharing, and as such, will be referred to as an “Indigenous consensus process”. 49 The panel composition ensured broad Indigenous representation from across the world using purposive sampling while prioritizing community members with extensive experience and knowledge in traditional Indigenous medicines. This included representatives from Canada (Denésuliné [N.R.]), Colombia (Inga [M.E.], Misak [J.C.]), El Salvador (Nahua Pipil Kakawira [J.N.R.]), Guatemala (Maya Kakchiquel [A.S.T.]), Kenya (Kikuyu [C.G.]), Mexico (Maya Tseltal [Y.C.], Nahua [Y.C.], and Wixárika [Y.V.R.]), Peru ([K.A.]), and the United States (Chickasaw [D.M.]). The eligibility for participation was flexible and based on expertise within the topic area, having prominent positions within Indigenous spaces, and those with established Indigenous networks. Eligible participants could hold institutional and community-engaged relevant positions regarding their knowledge in Indigenous medicine, the defense of the rights of Indigenous Peoples, and Indigenous advocacy at the international level. No invited members declined participation; however, four potential groups members had community and/or international engagements that conflicted with our meeting time and were not able to continue with the process.

The Indigenous consensus process had three stages that lasted from October 28, 2021, to March 11, 2022. The first stage was conducted in the form of virtual meetings focused on the guiding questions of how the psychedelic industry has affected Indigenous communities; how to reckon with abusive practices and reorient the field towards reparation, inclusion, and belonging of Indigenous insights; critical changes that need to happen before bridging knowledge systems; and recommendations on how to approach traditional Indigenous medicine ethically in the West. Shared goals were prioritized with a focus on identifying potential collaborative solutions to bring healing to the world, while also providing reparations for historical abuse. In the second stage of the consensus process, an initial draft was created based on the first stage of the work, which was circulated for high-level reflection, feedback, and edits by all group members. The feedback and edits resulted in several revisions of the draft consensus document over several weeks. The third stage of the process was a final virtual meeting to address any remaining areas for consensus. Two subsequent drafts were produced before a final consensus was reached. The research process was reviewed and approved as not Human Subject Research by the University of California at Berkeley's Committee for Protection of Human Subjects of the Office for Protection of Human Subjects (FWA# 00006252).

Eight ethical principles defined

This Indigenous consensus process was determined to outline the critical elements in ensuring appropriate inclusion and recognition of the rights of historically marginalized voices within the Western psychedelic research and praxis. It is important to emphasize that while there are similar experiences and outlooks amongst Indigenous Peoples worldwide, the principles shared here come from the voice of the participants’ respective communities; however, the consensus group is confident that this process has captured important elements that may be relevant to many Indigenous Nations. Despite this, the group recognizes that other potential elements of relevance could be identified as this topic is further contextualized to regional settings. Additionally, there are likely some Indigenous communities that are not wanting to engage in this dialogue for many complex but meaningful reasons, and those views should be respected. Nevertheless, the group initiates this critical conversation within the field of psychiatry and other relevant research and practice spaces (both Western and Indigenous), with the hopes of promoting wider dialogue and action.

The consensus group identified eight interconnected ethical principles categorized within four overarching categories concerning traditional Indigenous medicines use in Western psychedelic research and practice, including: (1) Reverence, (2) Respect, (3) Responsibility, (4) Relevance, (5) Regulation, (6) Reparation, (7) Restoration, and (8) Reconciliation (see Table 1 ). A summary of the main categories and the ethical principles associated with each category will be presented here. Concrete problems were additionally highlighted within each of the principles as it pertains to current practice, with suggested actions for moving reconciliation forward within Western psychedelic research and praxis.

Table 1

The main categories and eight individual ethical principles concerning traditional Indigenous medicines use in Western psychedelic research and practice.

Acknowledgment

There is need for the direct acknowledgement of Indigenous traditional knowledges and practices being the root of Western psychedelic medicine. This acknowledgement category is represented by two interconnected ethical principles that drive the practice and use of psychedelic medicines within Indigenous communities.

Reverence for Mother Nature

Traditional Indigenous medicine is an ethical, ecosystem-protective, and holistic system of medicine that interconnects humans and the environment. A sense of reverence for the planet guides all relationships, as well as a commitment to preserve all life. Traditional Indigenous medicine from a systems and relational perspective prompts insight for compassionate living and awareness of collective care to sustain the well-being of the medicines themselves as well as all future generations.

Concrete problem

Western psychedelic research and practice has its roots within traditional Indigenous medicines systems yet have turned ‘kincentric’ approaches (treating all relationships, including medicines, as kin) to anthropocentric approaches (human-centric). This anthropocentric approach fails to adequately reference or acknowledge Indigenous paradigms in Western procedures, thus expropriating Indigenous knowledges while separating the medicines from the context of their original environments.

Reverence-governed actions

The explicit acknowledgement of Indigenous Peoples and their traditional medicines and practice as the root of Western psychedelic research and practice; Western psychedelic research and practice references Indigenous concepts of reverence as guided by local Indigenous scholars and communities; the Western psychedelic research and practice community takes action to support Indigenous Nations protection of the at-risk land and natural environments where these traditional Indigenous medicines originate; support Indigenous Peoples in their fulfillment of the right to life and of the right to live in peace on ancestral lands.

Respect Indigenous ways of knowing and being

A respectful approach to engaging with Indigenous Peoples and their ways of knowing and being is urgently needed within Western psychedelic research and praxis. A respectful method consists of approaching Indigenous knowledge systems through relationship building first and foremost with Indigenous scholars and practitioners, Indigenous organizations, and/or respected traditional knowledge-holders within regional contexts. This respectful method also includes following the respective traditional Indigenous protocols in the region in addition to upholding free, prior, and informed consent (FPIC) at all levels of the engagement process when it comes to the potential use of Indigenous knowledges in new contexts (“nothing about us, without us” 52 ).

Many Western-based psychedelic research, training programs, and facilitated psychedelic sessions decontextualize and capitalize on Indigenous ceremonies, principles, and ideas without the FPIC of communities where these medicines and related practices originated.

Respect-governed action

Western psychedelic research and practice movements respectfully request the involvement of Indigenous Peoples, Indigenous scholars, Indigenous organizations, and/or traditional knowledge holders as ‘leaders’ in the potential development of research and therapies involving tangible or intangible traditional Indigenous medicines; Western psychedelic research and practice movements uphold and actively engage in FPIC with Indigenous Nations, acknowledging that consent for participation can be withdrawn at any stage of the engagement or research process as determined by the respective Indigenous Nation; Western psychedelic research and practice movements fund the development and/or sustainment of regional Indigenous-led and Indigenous-run ethical review bodies that are tasked with overseeing research and practice engagement within their regions; Western psychedelic research and practice movements support and fund Indigenous Nations development or refinement of biocultural community protocols 53 and/or community ethical protocols to determine how stakeholders, researchers, and other individuals should interact with their communities in regard to the use or practice of psychedelic medicine.

Knowledge translation and education

There is need for culturally appropriate and accurate translations of Indigenous knowledges within Western psychedelic research and practices at institutional and civil society levels. A dialogue of reclamation and revitalization focused on the rights of Indigenous Peoples to their tangible and intangible traditional Indigenous medicines are foundational to this educational effort. This knowledge translation and education main category is represented by two interconnected ethical principles that drive the knowledge transmission of psychedelic medicines within Indigenous communities.

Responsibility for use, benefits, harms

Institutions that lead, host, or enable Western psychedelic research and/or practice should be held accountable for the promotion or engagement with any cultural appropriation, for any capitalization off of Indigenous Peoples and their cultural practices without their FPIC, and for enabling directly or indirectly white-supremacist legacies in psychedelic research, training, and practice.

Western psychedelic research and practice have generated and enabled patterns of consumption, cultural appropriation, and the capitalization of Indigenous knowledges, with a sharp increase in psychedelic public and corporate use, while Indigenous Peoples continue to struggle for basic access to health services and minimum standards of living around the globe.

Responsibility-governed action

Institutions agree to undertake and fund a formal organizational review of any and all Western psychedelic research and practice in their environments through an Indigenous leadership process; institutions re-visit their institutional ethics board policies and procedures to ensure oversight and inclusion of Indigenous Peoples and Indigenous communities in the review and approval of any Western psychedelic research and/or practice projects; responsibility is shifted towards leadership and belonging for Indigenous Peoples, Indigenous pedagogies of learning, and Indigenous research and practice methodologies.

Relevance of Indigenous knowledges in psychedelic medicine

Indigenous Peoples and their traditional knowledges are relevant and needed within Western educational settings, research, and practice systems, and concrete efforts should be made to elevate their leadership and presence. Opening meaningful and cultural safe spaces for decolonizing pedagogies of learning, in addition to the decolonization of research and clinical methodologies, ensures contextual and inclusive commitment towards equitable and inclusive environments that fulfill statements of diversity, equity, and inclusion at all levels of the institution.

Western psychedelic research and/or practice institutional systems have often historically and contemporarily excluded Indigenous Peoples and their knowledge systems, prioritizing instead colonizing research and clinical methodologies that have served and advanced Eurocentric ideals and well-being at the peril of Indigenous community health and well-being.

Relevance-governed action

Incorporate through elevated and promoted Indigenous institutional leadership and FPIC processes, Indigenous science and relevant methodologies in Western psychedelic research and practice, led by Indigenous scholars and/or Indigenous practitioners; honour context-relevant methods of knowledge translation in education, training, and practice that respects Indigenous self-determination and sovereignty.

Intellectual property and reparation

The creation of strict legal mechanisms on intellectual property that recognizes the rights of Indigenous Peoples to their tangible and intangible knowledges and medicines, and the consequent distribution of benefits derived from the use and development of medicines and practices of Indigenous origin that were extracted and appropriate without the FPIC of Indigenous Peoples are urgently needed. The establishment of intellectual property mechanisms requires a direct commitment to the already established legal mechanisms currently unevenly adopted by countries (see Introduction for a review of relevant legal mechanisms). This intellectual property and reparation category is represented by two interconnected ethical principles.

Regulation of tangible and intangible uses of traditional Indigenous medicines

It is crucial to continue the generation of constitutional recognition, with specific clauses on the protection of the intellectual property of traditional Indigenous medicine and practice, and its use and development. Indigenous Peoples should decide upon the proper cross-border cooperation and increased awareness needed in the field, including capacity building, technology transfer, collaboration and cooperation on use, administration, and conservation of their knowledges and practices.

Regulatory advances protecting the intellectual property of traditional Indigenous medicine at the national and international levels are scarce.

Regulation-governed action

The legal development and regulatory expansion of formalized regulation and recognition of Indigenous traditional knowledges (including medicines) within conceptions of intellectual property systems must come from Indigenous self-determined rules of law to ensure culturally sensitive policies.

Reparation and sharing of benefits

Indigenous Peoples have the right to maintain, control, protect, and develop their own traditional knowledges, medicines, and cultures. Indigenous Peoples should additionally receive fair and equitable sharing of benefits derived from the use of any natural and genetic resources and intangible intellectual, cultural, and spiritual heritage as they see fit. In cases where knowledge, medicines, and/or resources were taken illegally or without the FPIC of Indigenous Peoples, agreed upon reparation, not excluding compensation post facto, should be prioritized.

Western psychedelic research and practices have benefited non-Indigenous Peoples at the expense of Indigenous communities and their knowledges.

Reparation-governed action

Reparations should seek to promote and safeguard self-determination, and enable restitution of appropriate cultural, intellectual, religious, and spiritual property with the FPIC of Indigenous Nations.

The inherent ‘belonging’ of Indigenous Peoples' perspectives within the psychedelic research and practice field is conceptualized by combining many of the elements of the first six ethical principles previously defined. Any potential partnerships or collaborations (or senses of belonging) with or within Indigenous Nations may be dictated by the attainment and actioning of the above stated six principles that set the stage for the next two ethical principles here defined.

Restoration of Indigenous authority

Indigenous Peoples knowledges, contexts, and relevant practices are restored as the guiding voices in the development of their tangible and intangible traditional Indigenous medicines and practices.

Western institutions in many cases have only recently attempted reciprocity and outreach with Indigenous Peoples to justify the extraction and capitalization of their medicines.

Restoration-governed action

Indigenous and Western systems are not yet of equal standing; therefore, restoration of Indigenous authority is imperative for any fruitful and meaningful collaboration into the future.

Reconciliation of Indigenous–Western relations

Work with Indigenous Peoples and their traditional Indigenous medicine systems should involve local, national, and international levels of cooperation with governmental and non-governmental organizations, and humanitarian and environmental bodies to establish restorative, 54 , 55 transitional, and transformative justice procedures. 56 , 57 , 58 , 59 , 60 This level of cooperation will serve to highlight Indigenous discourse and promote capacities rooted in Indigenous ways of knowing and being as a human right imperative.

The current state of Western psychedelic research and practice in institutional and non-institutional settings is not yet conducive to a reconciliation of Indigenous and Western relationships.

Renovation-governed action

Direct engagement and enactment of the previously described ethical principles (see Table 1 ) will serve as a necessary steppingstone to right relations between Western and Indigenous systems and Peoples; actions and interventions concerning traditional Indigenous medicines must be developed through direct participatory methodologies respecting the rights of local Indigenous autonomy, governance, and self-determination.

The way forward

To help orient this consensus process more directly towards solutions, we further summarize in Table 2 additional recommended practical solutions within Western psychedelic research and practice. This consensus process emphasized that by continuing the extraction and commercialization of various traditional Indigenous medicines, Western institutions are destroying the core themes of Indigenous life in the following important ways: ( i ) the glorification of psychedelics 61 excites harmful narratives of exceptionalism that result in spiritual consumerism 50 and exploitative tourism 14 , 62 that is very often managed by Westerners 63 ; ( ii ) the unsustainable foraging of Indigenous medicines make them increasingly unavailable for local use 13 , 64 , 65 ; ( iii ) Indigenous Peoples are exposed to extreme violence from the infiltration of drug cartels into traditional territories that often source raw materials from forest habitats (e.g., MDMA) 66 , 67 ; ( iv ) the spreading of false information about a particular plant medicine being the one key pill to human enlightenment. 68 , 69 While these medicines may contribute towards powerful and transformative solutions to the health and planetary crisis, they can also lose their meaning when deprived of their cultural container. We hope that the eight ethical principles detailed here spark important conversation and action within the psychiatry and psychedelic research community towards better, more respectful relations.

Table 2

The eight ethical principles applied within western psychedelic research.

This Indigenous-led group of practitioners, scholars, lawyers, human rights defenders, and activists will be continuing this work by examining routes of implementation, policy recommendations, and the practical application of these principles from an Indigenous lens involving regional, national, and international frameworks and community networks. As we build equitable and inclusive societies, institutions, and fields, embracing diverse knowledge systems will ensure greater well-being for all planetary communities. Indigenous voices can be a powerful and beneficial solutions-orientated force for well-being derived from ancestral wisdom and insight from the heart of Mother Earth. 49

Contributors

Original project and design, Y.C.; writing–original draft, Y.C.; funding acquisition and project administration, Y.C.; conceptualisation and methodology, Y.C., N.R., K.A., C.G., J.N.R., R.V., M.E.Ch., Y.V.R., J.C., D.M., and A.S.; data curation, Y.C., N.R., K.A., C.G., J.N.R., R.V., M.E.Ch.; investigation, Y.C., N.R., K.A., C.G.,; writing–editing, Y.C., N.R., K.A., C.G., R.V., M.E.Ch., J.C., D.M., and J.N.R; writing–review, Y.C. and N.R.

Declaration of interests

We declare no competing interests.

Acknowledgments

We recognize Mother Earth with Her presence and guiding voice representing all directions, and inclusive of earth, water, air, and fire beings in the vastness of our relations. We acknowledge all these beings as Our Kin. We acknowledge and pay respects to the rightful stewards of the Lands we call home and wholeheartedly recognize our human and other-than-human relatives displaced and dispossessed of territories and identities. May we all return to a sense of home. We bow to the Elders past, present, and emerging of all Indigenous Peoples and Nations, and those of the authors Chickasaw, Cofán, Coreguaje, Denésuliné, Inga, Kamentsá, Kikuyu, Maya (Kaqchikel, Tseltal), Misak, Nahua (Tlaxcalteca, Pipil Kakawira), Quechua, Siona, and Wixárika Peoples, as we weave trust with our planetary relatives, and we celebrate Spirit. We additionally encourage those individuals and organizations that have begun their journeys to rightful relations to continue this work alongside Indigenous communities.

Funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Appendix A Supplementary data related to this article can be found at https://doi.org/10.1016/j.lana.2022.100410 .

Appendix A. Supplementary data

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How to Thrive as You Age

Got tinnitus a device that tickles the tongue helps this musician find relief.

Allison Aubrey

After using the Lenire device for an hour each day for 12 weeks, Victoria Banks says her tinnitus is "barely noticeable." David Petrelli/Victoria Banks hide caption

After using the Lenire device for an hour each day for 12 weeks, Victoria Banks says her tinnitus is "barely noticeable."

Imagine if every moment is filled with a high-pitched buzz or ring that you can't turn off.

More than 25 million adults in the U.S., have a condition called tinnitus, according to the American Tinnitus Association. It can be stressful, even panic-inducing and difficult to manage. Dozens of factors can contribute to the onset of tinnitus, including hearing loss, exposure to loud noise or a viral illness.

There's no cure, but there are a range of strategies to reduce the symptoms and make it less bothersome, including hearing aids, mindfulness therapy , and one newer option – a device approved by the FDA to treat tinnitus using electrical stimulation of the tongue.

The device has helped Victoria Banks, a singer and songwriter in Nashville, Tenn., who developed tinnitus about three years ago.

"The noise in my head felt like a bunch of cicadas," Banks says. "It was terrifying." The buzz made it difficult for her to sing and listen to music. "It can be absolutely debilitating," she says.

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Tinnitus bothers millions of americans. here's how to turn down the noise.

Banks tried taking dietary supplements , but those didn't help. She also stepped up exercise, but that didn't bring relief either. Then she read about a device called Lenire, which was approved by the FDA in March 2023. It includes a plastic mouthpiece with stainless steel electrodes that electrically stimulate the tongue. It is the first device of its kind to be approved for tinnitus.

"This had worked for other people, and I thought I'm willing to try anything at this point," Banks recalls.

She sought out audiologist Brian Fligor, who treats severe cases of tinnitus in the Boston area. Fligor was impressed by the results of a clinical trial that found 84% of participants who tried Lenire experienced a significant reduction in symptoms. He became one of the first providers in the U.S. to use the device with his patients. Fligor also served on an advisory panel assembled by the company who developed it.

"A good candidate for this device is somebody who's had tinnitus for at least three months," Fligor says, emphasizing that people should be evaluated first to make sure there's not an underlying medical issue.

Tinnitus often accompanies hearing loss, but Victoria Banks' hearing was fine and she had no other medical issue, so she was a good candidate.

Banks used the device for an hour each day for 12 weeks. During the hour-long sessions, the electrical stimulation "tickles" the tongue, she says. In addition, the device includes a set of headphones that play a series of tones and ocean-wave sounds.

The device works, in part, by shifting the brain's attention away from the buzz. We're wired to focus on important information coming into our brains, Fligor says. Think of it as a spotlight at a show pointed at the most important thing on the stage. "When you have tinnitus and you're frustrated or angry or scared by it, that spotlight gets really strong and focused on the tinnitus," Fligor says.

"It's the combination of what you're feeling through the nerves in your tongue and what you're hearing through your ears happening in synchrony that causes the spotlight in your brain to not be so stuck on the tinnitus," Fligor explains.

A clinical trial found 84% of people who used the device experienced a significant reduction in symptoms. Brian Fligor hide caption

A clinical trial found 84% of people who used the device experienced a significant reduction in symptoms.

"It unsticks your spotlight" and helps desensitize people to the perceived noise that their tinnitus creates, he says.

Banks says the ringing in her ears did not completely disappear, but now it's barely noticeable on most days.

"It's kind of like if I lived near a waterfall and the waterfall was constantly going," she says. Over time, the waterfall sound fades out of consciousness.

"My brain is now focusing on other things," and the buzz is no longer so distracting. She's back to listening to music, writing music, and performing music." I'm doing all of those things," she says.

When the buzz comes back into focus, Banks says a refresher session with the device helps.

A clinical trial found that 84% of people who tried Lenire , saw significant improvements in their condition. To measure changes, the participants took a questionnaire that asked them to rate how much tinnitus was impacting their sleep, sense of control, feelings of well-being and quality of life. After 12 weeks of using the device, participants improved by an average of 14 points.

"Where this device fits into the big picture, is that it's not a cure-all, but it's quickly become my go-to," for people who do not respond to other ways of managing tinnitus, Fligor says.

One down-side is the cost. Banks paid about $4,000 for the Lenire device, and insurance doesn't cover it. She put the expense on her credit card and paid it off gradually.

Fligor hopes that as the evidence of its effectiveness accumulates, insurers will begin to cover it. Despite the cost, more than 80% of participants in the clinical trial said they would recommend the device to a friend with tinnitus.

But, it's unclear how long the benefits last. Clinical trials have only evaluated Lenire over a 1-year period. "How durable are the effects? We don't really know yet," says audiologist Marc Fagelson, the scientific advisory committee chair of the American Tinnitus Association. He says research is promising but there's still more to learn.

Fagelson says the first step he takes with his patients is an evaluation for hearing loss. Research shows that hearing aids can be an effective treatment for tinnitus among people who have both tinnitus and hearing loss, which is much more common among older adults. An estimated one-third of adults 65 years of age and older who have hearing loss, also have tinnitus.

"We do see a lot of patients, even with very mild loss, who benefit from hearing aids," Fagelson says, but in his experience it's about 50-50 in terms of improving tinnitus. Often, he says people with tinnitus need to explore options beyond hearing aids.

Bruce Freeman , a scientist at the University of Pittsburgh Medical Center, says he's benefitted from both hearing aids and Lenire. He was fitted for the device in Ireland where it was developed, before it was available in the U.S.

Freeman agrees that the ringing never truly disappears, but the device has helped him manage the condition. He describes the sounds that play through the device headphones as very calming and "almost hypnotic" and combined with the tongue vibration, it's helped desensitize him to the ring.

Freeman – who is a research scientist – says he's impressed with the results of research, including a study published in Nature, Scientific Reports that points to significant improvements among clinical trial participants with tinnitus.

Freeman experienced a return of his symptoms when he stopped using the device. "Without it the tinnitus got worse," he says. Then, when he resumed use, it improved.

Freeman believes his long-term exposure to noisy instruments in his research laboratory may have played a role in his condition, and also a neck injury from a bicycle accident that fractured his vertebra. "All of those things converged," he says.

Freeman has developed several habits that help keep the high-pitched ring out of his consciousness and maintain good health. "One thing that does wonders is swimming," he says, pointing to the swooshing sound of water in his ears. "That's a form of mindfulness," he explains.

When it comes to the ring of tinnitus, "it comes and goes," Freeman says. For now, it has subsided into the background, he told me with a sense of relief. "The last two years have been great," he says – a combination of the device, hearing aids and the mindfulness that comes from a swim.

This story was edited by Jane Greenhalgh

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April 27, 2024

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Global study shows a third more insects come out after dark

by University of Western Australia

A groundbreaking study, led by Dr. Mark Wong of The University of Western Australia, has provided the first global picture of insect activity patterns across the fundamental day–night cycle.

"Through our extensive research, we've finally been able to provide a definitive answer to the age-old question of whether there are more insects out at night than during the day," said Dr. Wong. "Our global analysis not only shows that insect activity rises by a third (31.4%) during the night on average, but crucially reveals key ecological factors driving patterns in insect activity across the Earth."

The activity patterns of insects across the day–night cycle are a surprisingly understudied area in ecology, as such patterns cannot be detected by common methods used for sampling insects. For example, sweep netting captures inactive insects, while light traps do not work as well during the day as they do during the night.

The researchers overcame this challenge by identifying studies that sampled insects during the day and night with traps that specifically caught moving insects, such as pitfall traps, flight interception traps, and aquatic drift nets.

After meticulously combing through thousands of studies, they identified 99 studies spanning from 1959 to 2022, which had used these methods to document insect activity patterns across diverse landscapes, from tropical jungles to temperate forests, arid grasslands and aquatic ecosystems. The total number of insects observed exceeded 3 million individuals.

The results of the study, published in the journal Nature Communications , reveal multiple ecological factors that shape insect activity patterns across the globe.

Multiple insect groups such as mayflies, caddisflies, moths, and earwigs, were found to be more abundant during the night. Conversely, daytime saw increased activity among thrips, bees, wasps, and ants.

Nocturnal activity was also more common in rivers and streams. In these aquatic habitats, there could be twice as many insects active during the night. In contrast, land-based insects generally had higher diurnal activity, especially in grasslands and savannas, where the number of insects out and about could triple during the day.

Dr. Wong said these contrasting patterns in terrestrial and aquatic ecosystems may reflect strategies for predator avoidance. "Fish tend to hunt aquatic insects during the day, whereas nocturnal animals such as bats make life on land more hazardous at night."

The analysis also highlighted the influence of environmental factors, such as temperature, on insect activity at the global scale. "We found peak levels of nocturnal activity in the warmer regions of the world, as more insects likely sought refuge from the heat of the day," said Dr. Wong.

However, the study also sounded a warning on the threats facing insects, emphasizing the importance of conservation efforts.

"Our findings point to the threat of global warming. In the hottest regions in the world such as the tropics, the warming trend may further reduce the activity of nocturnal insects that are already struggling to cope with heat. On top of that, artificial lighting is detrimental to nocturnal insects, disrupting their natural behaviors in ecosystems."

Insects perform many vital "ecosystem services" such as pollination, nutrient cycling and pest control. Many of these services may be provided at night, when more insects are active.

Dr. Wong spoke to the lasting value of ecological fieldwork to better understand insect activity patterns. "Such research can be exhausting, as traps need to be installed and replaced multiple times over days and nights, across many different locations.

"But it is absolutely indispensable. Insects are among the most diverse and important organisms on our planet, and studying their intricate rhythms represents not just a scientific endeavor, but an imperative for conserving biodiversity on a rapidly changing planet."

Journal information: Nature Communications

Provided by University of Western Australia

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