Podcasts about risk evaluation

In this episode, YS Chi speaks with Bill Madison, CEO of our insurance business at LexisNexis Risk Solutions to explore the dynamics within the insurance industry and why premiums keep rising across the board. To understand the challenges consumers and insurance carriers are facing today, Bill takes us back to 2020, right at the beginning of the pandemic. This episode is also available on YouTube at https://youtu.be/PGgi39UtbBE

Send us a textNavigating Cybersecurity and Insurance: Insights from Industry Experts Craig Sekowski  and Ralph Pasquariello Join host Chris Whitaker on this episode of The Wireless Way, where he converses with seasoned IT executives Craig Sekowski  and Ralph Pasquariello . Discover their extensive backgrounds in IT, insurance, and fintech, and get insights on the intersection of cybersecurity and insurance. Learn about their innovative CARE program (Cyber Insurance Assessment and Risk Evaluation) and how it helps businesses measure and manage risk effectively. They delve into the complexities of cybersecurity, the importance of adequate insurance, and the ever-evolving landscape of cyber threats. Featuring a discussion on the significance of multi-level security approaches and real-world examples, this episode is a crucial listen for tech enthusiasts and business owners alike.00:00 Introduction and Host's Welcome00:32 Guest Introductions: Craig Sekowski and Ralph Pasquariello 03:04 Craig's Career Journey03:55 Ralph's Career Journey07:29 The Origin of the CARE Report12:13 Small Business Cyber Insurance Needs19:30 Cybersecurity Trends and Challenges27:16 Client Security Assessment28:03 Analyzing Client Risk28:19 Deep Dive into Threat Titles28:38 External Network Data and Simulations31:36 Industry-Specific Risks33:37 Benchmarking and Remediation35:39 Importance of Mobile Device Management37:16 Final Thoughts and Recommendations39:03 Conclusion and Contact Information39:59 Introduction to Pure Talk41:32 Cybersecurity and Insurance Insights44:38 MDM and Corporate-Owned Devices46:03 Partnering for Cybersecurity Solutions49:23 Final Words and New Video SeriesLearn more about The Tech CollectiveOur Sponsor, PuretalkSupport the showCheck out my website https://thewirelessway.net/ use the contact button to send request and feedback.

CancerNetwork®, in collaboration with The American Society for Transplantation and Cellular Therapy (ASTCT), organized an X Space hosted by Rahul Banerjee, MD, FACP, an assistant Professor in the Clinical Research Division at the Fred Hutchinson Cancer Center in Seattle, Washington, and Shernan Holtan, MD, the chief of Blood and Marrow Transplantation and professor of Medicine at Roswell Park Comprehensive Cancer Center.  The conversation took place during the 2025 Tandem Meeting and highlighted many significant presentations and posters on CAR T-cell therapies and transplantation, Banerjee's and Holtan's respective areas of expertise. The following trials were discussed: LBA1 - Phase II Multicenter Trial of Idecabtagene Vicleucel (Ide-cel) Followed By Lenalidomide Maintenance for Multiple Myeloma Patients with Sub-Optimal Response after an Upfront Autologous Hematopoietic Cell Transplantation: Top Line Results from the BMT CTN 1902 Clinical Trial1 “This [study] is nice because it merges 2 worlds. It's like a tandem—but not really a tandem—because you're not doing 2 transplants back-to-back. You're doing a transplant followed by CAR T-cell therapy,” said Banerjee. Abstract 50 - CAR T Cell Therapy in Early Relapsed/Refractory Large B-Cell Lymphoma: Real World Analysis from the Cell Therapy Consortium2 “In a relatively small cohort, [investigators] found no difference in 9-month survival whether someone got their [CAR T cells] in second-line therapy vs third-line therapy from a statistical perspective. If you look at the curves, it looks like there is a potential benefit to second-line therapy, but there was not enough statistical power to determine a difference,” said Holtan. Poster 340 - CD83 Expression By Human Breast Cancer Mediates Effective Killing By CAR T3 “If there's a way to do [the therapy] armored and have a paracrine delivered in real time—and not given to the whole body—[so] the patient [would] have all the adverse effects and cytokine release syndrome release on their own…that would be awesome,” stated Banerjee.  Poster 317 - Risk Factors for Immune Effector Cell-Associated Enterocolitis (IEC-colitis) in Patients with Relapsed Myeloma Treated with Ciltacabtagene Autoleucel (cilta-cel)4 “From the best that we can tell, ironically, corticosteroids aren't the fix that we want them to be [for immune effector cell-associated colitis]…We were like ‘Diarrhea, whatever. Let's give some steroids and treat it like gut graft-versus-host-disease,' but these patients [didn't] respond as well [to that],” said Banerjee. Poster 572 - Post-CAR-T Driving Restrictions Appear Unnecessary after Week 4: Data from the US Multiple Myeloma Immunotherapy Consortium5 “Patients and their caregivers [who have] put their life aside for 4 weeks just to get through CAR T-cell therapy and the Risk Evaluation and Mitigation Strategies requirements are now being told ‘You're free to go, but you can't drive for 4 weeks, which means you can't get your own groceries or…go to doctor's appointments by yourself.' Basically, we argue…that this [requirement] is not evidence-based,” stated Banerjee.  Presentation 58 - Physical Function Measures Identify Non-Hodgkin Lymphoma Patients at High Risk of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and 1-Year Mortality after Chimeric Antigen Receptor T (CAR-T) Cell Therapy6 “This [presentation] highlights that even within a high [CAR-HEMATOTOX group], those patients were at extraordinarily high risk of not benefitting from CAR T-cell therapy, and these tests are so simple to do. It's going to be interesting to see if others can reproduce this,” said Holtan. Poster 618 - Comparison of Outcomes after Hematopoietic STEM Cell Transplantation (HCT) for Myelodysplastic Syndrome (MDS) Patients Older or Younger THAN 65 YEARS Old. a Retrospective Analysis of the Latin America Registry7 “My personal hope for this space is that our field can come up with more novel conditioning regimens such that we can ablate the marrow without causing those gastrointestinal toxicities or other organ toxicities [while] doing that so effectively that we don't even need maintenance therapies for a lot of conditions,” stated Holtan. Presentation 39 - Determinants of Immune Suppression Discontinuation in the Modern Era: A CIBMTR Analysis of 18,642 Subjects8 “I'm going to make a provocative prediction for the next paper [approximately 10 years from now]. I predict that steroids won't be the first-line therapy for acute or chronic graft-versus-host-disease,” Holtan said. Poster 516 - Patient Experiences with Chronic Graft-Versus-Host Disease and Its Treatment in the United States: A Retrospective Social Media Listening Study9 “We can still work together to make life as good as we possibly can [for patients], to improve physical function, to take away some of this mental distress, and then work together for advocacy too. [We can] help with peer support, help with resources, and help relieve some of that misunderstanding in the community,” stated Holtan. References 1.        Garfall AL, Pasquini MC, Bai L, et al. Phase II multicenter trial of idecabtagene vicleucel (ide-cel) followed by lenalidomide maintenance for multiple myeloma patients with sub-optimal response after an upfront autologous hematopoietic cell transplantation: top line results from the BMT CTN 1902 clinical trial. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Abstract LBA-1. 2.        Rojek AE, Ahmed N, Gomez-Llobell M, et al. CAR T cell therapy in early relapsed/refractory large B-cell lymphoma: real world analysis from the cell therapy consortium. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Abstract 50. 3.        Betts BC, Davilla ML, Linden AM, et al. CD83 expression by human breast cancer mediates effective killing by CAR T. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Poster ID 340. 4.        Chang Lim KJ, Chhabra S, Corraes ADMS, et al. Risk factors for immune effector cell-associated enterocolitis (IEC-colitis) in patients with relapsed myeloma treated with ciltacabtagene autoleucel (cilta-cel). Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Poster ID 317. 5.        Banerjee R, Richards A, Khouri J, et al. Post-CAR-T driving restrictions appear unnecessary after week 4: data from the US multiple myeloma immunotherapy consortium. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Poster ID 572. 6.        Herr M, McCarthy P, Jacobsen H, et al. Physical function measures identify non-Hodgkin lymphoma patients at high risk of immune effector cell-associated neurotoxicity syndrome (ICANS) and 1-year mortality after chimeric antigen receptor T (CAR-T) cell therapy. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Presentation ID 58. 7.        Duarte FB, Garcia YDO, Funke VAM, et al. Comparison of outcomes after hematopoietic STEM cell transplantation (HCT) for myelodysplastic syndrome (MDS) patients older or younger THAN 65 YEARS Old. A retrospective analysis of the Latin America registry. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Poster ID 618. 8.        Pidala J, DeFlilipp Z, DeVos J, et al. Determinants of immune suppression discontinuation in the modern era: a CIBMTR analysis of 18,642 subjects. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Presentation ID 39. 9.        Cowden M, Derrien-Connors C, Holtan S, et al. Patient experiences with chronic graft-versus-host disease and its treatment in the United States: A retrospective social media listening study. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Poster ID 516.

In this episode of ThimbleberryU, we tackle the complex and often surprising situation of receiving an early retirement offer from your employer.  Amy walks us through the essential considerations when navigating such an offer, emphasizing that while the initial reaction may be shock or panic, taking a step back to calmly assess the situation is crucial.The first point Amy makes is that understanding the details of the offer is essential. It's not just about a severance payment; early retirement packages might also include healthcare benefits, stock options, and other perks. A deep dive into these aspects is necessary to fully understand the implications, especially regarding taxes and retirement accounts. For example, lump-sum payments could push someone into a higher tax bracket, impacting overall cash flow. Additionally, unvested stock options and healthcare subsidies could significantly affect the offer's true value. Therefore, thoroughly reviewing the package over time ensures that all questions are addressed before making a decision.Amy also discusses evaluating the risks of turning down an offer, such as the possibility of forced retirement or layoffs in the near future. For some, making the decision themselves—rather than waiting for the company—can provide a greater sense of control and ease of mind. We also explore the financial side: big payouts often mean big taxes, and drawing from retirement accounts prematurely could result in penalties. Amy explains that, for some clients, continuing to work may not improve their retirement outlook due to the high tax burden on their income.Beyond the financial, the emotional aspect of this decision is key. Amy emphasizes the importance of aligning the offer with personal lifestyle goals. Is this a chance to change careers, pursue a passion project, or even relocate to be closer to family? For some, taking the offer can provide a sense of relief and new opportunities, while for others, the sacrifices may not be worth it.Ultimately, the decision to accept or decline an early retirement offer should be made with long-term happiness in mind. It's not just about the money—it's about living the life you want, both now and in retirement. Amy advises listeners not to let fear drive the decision and to seek expert guidance to navigate these complex choices. To get in touch with Amy and her team at Thimbleberry Financial, call 503-610-6510 or visit thimbleberryfinancial.com.

Explore the basis for and controversy surrounding the US Food and Drug Administration requiring a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. Full text of the manuscript is available at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.2034.

Vahavta has created some amazing resources, in particular, the Risk Evaluation Database, which curates possible risks for various BDSM activities (like rope bondage!) we might engage in - from the common (bruising) to the ones you're unlikely to think of (retina detachment), even the very rare ones.  In this second part of Fox and Mya's interview with her, they discuss: • Why she put together the Risk Evaluation Database (RED) • What is a risk profile and why might you need one for rope bondage • How to use RED to create your own risk profile • Tips for kinkies with chronic health issues • What skills can chronic health issues bring • How she processed the impact of her health condition on her choices • The impact of fitness on rope bondage • How we can make the conversation about fitness and rope bottoming more useful • Tips for rope bottoms on pain processing • And more! Vahavta writes, teaches, and speaks on CNC, emotional S/m, kink + chronic illness/disability, pain processing, and negotiation and communication on the edge. Feel free to share your thoughts on the topic in the comments

Send us a textToday, we're joined by Eskild Lund Sørensen, Managing Partner at Intactix Systems Inc. and a seasoned leader with over two decades of experience in creating sustainable, people-centred safety cultures across diverse, high-risk industries. Eskild introduces us to the CARE Model - Culture and Risk Evaluation - a comprehensive approach that goes beyond checklists and compliance.Through his unique experiences, from challenging projects in the icy landscapes of Greenland to complex operations in the US, Eskild shares insightful stories about building psychological safety, embracing cultural awareness, and using empathy as a driver for effective risk management.His journey reveals the real impact of prioritising open communication and practical competency across teams, showing how CARE can transform both safety and operational outcomes.Whether you're curious about the human side of safety or seeking fresh perspectives for high-stakes environments, this episode offers valuable lessons through Eskild's personal experiences on what it means to cultivate a lasting safety culture.Tune in to discover how CARE can reshape safety in your industry.Click

On June 26, 2024, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform — Eight Years Later. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions. B&C and ELI are pleased to co-sponsor this episode of All Things Chemical® to enable our podcast audience to listen to these sessions. Maria J. Doa, Ph.D., Senior Director, Chemicals Policy, Environmental Defense Fund (EDF), moderated Panel 2: Risk Evaluation and the Supporting Role Sections 4 and 8 Play. The panelists included David B. Fischer, Counsel, Keller and Heckman LLP; Jeffery T. Morris, Ph.D., Director, Existing Chemicals Risk Assessment Division, Office of Pollution Prevention and Toxics (OPPT), EPA; Katherine O'Brien, Senior Attorney, Toxic Exposure and Health Program, Earthjustice; Judah Prero, Counsel, Arnold & Porter; and Tracey Woodruff, Ph.D., Professor and Director, University of California, San Francisco, Program on Reproductive Health and the Environment. The panel considered EPA's revised chemical prioritization and risk evaluation processes; the role and extent of peer review; and the utility and timing of Section 4 test rules. More information on EPA's final 2024 rule amending the risk evaluation framework rule is available in our May 14, 2024, memorandum. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2024 Bergeson & Campbell, P.C.  All Rights Reserved

Guideline evolution is driven by ongoing research; recent studies like PeriOperative ISchemic Evaluation-3 Trial (POISE-3) and trials such as OPtimisation of Peri-operaTive CardIovascular Management to Improve Surgical outcomE II (OPTIMISE II) trial may influence recommendations on hemodynamic management and the use of tranexamic acid. Future guidelines are expected to integrate machine learning models for risk prediction, addressing complex patient phenotypes and interactions. Discontinuation vs. continuation of renin–angiotensin system inhibition before non-cardiac surgery: the SPACE trial has challenged existing practices regarding the discontinuation of ACE inhibitors or ARBs, highlighting the dynamic nature of medical guidelines and the continuous incorporation of new evidence to enhance patient care. Presented by Andy Cumpstey and Joff Lacey with Mark Edwards, Consultant in Anaesthesia and Perioperative Medicine, University Hospital Southampton Honorary Senior Clinical Lecturer, University of Southampton and John Whittle, Clinical Academic working in Perioperative Translational Medicine at UCL and Honorary Consultant in Perioperative Medicine, Anaesthesia and Critical Care at University College Hospitals London. -- More on POISE-3 here: https://clinicaltrials.gov/study/NCT03505723 More on OPTIMISE II here: https://optimiseii.org/ More on the SPACE trial here: https://doi.org/10.1093/eurheartj/ehad716  

Risk Evaluation and Mitigation Strategies (REMS) requirements oversee riskier medications and review the serious medication safety concerns frequently. This podcast will review REMS pearls and provide REMS Resources.  Join us to learn how to monitor, prevent, and manage serious risks associated with REMS medications. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

In a conversation with CancerNetwork®, Nausheen Ahmed, MD, spoke about optimizing monitoring strategies for patients with B-cell non-Hodgkin lymphoma who undergo treatment with CAR T-cell therapy. Ahmed, an associate professor in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center, discussed the possibility of offering more flexible monitoring periods for patients in the context of findings from a real-world study published in Blood Advances.1 Data from her study showed that the occurrence of new onset cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) was rare at more than 2 weeks following CAR T-cell therapy infusion. Additionally, late non-relapse mortality generally resulted from infectious complications. The FDA implemented a Risk Evaluation and Mitigation Strategy (REMS) to help manage the risk of severe CRS and ICANS by requiring patients to reside within 2 hours of an authorized treatment center for 4 weeks following CAR T-cell therapy infusion.2 According to the study authors, this mitigation strategy may create significant barriers to CAR T-cell therapy access among certain patients and caregivers who need to relocate as part of a treatment plan.  Findings from Ahmed's study supported the development of individualized monitoring strategies depending on the stability of the patient. She and her coauthors proposed a 2-week monitoring period for patients while allowing for an optional increase to 4 weeks based on factors such as physician comfort and availability of local community oncology support. As Ahmed emphasized during the discussion, having flexibility in these monitoring periods could help mitigate financial and geographic obstacles preventing adequate access to CAR T-cell therapy among patients. “There has to be more of a hybrid model of care. There has to be more involvement of our referring doctors or community doctors in detecting and managing these infections or working with the specialized center in order to bypass the [emergency room] and other strategies to help these patients,” Ahmed said. “If there is enough data to say that the patients do not need extra restrictions beyond 2 weeks, which is what our studies show, then reconsidering the requirements will be one step towards decreasing disparities in access.” References 1.        Ahmed N, Wesson W, Lutfi F, et al. Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel. Blood Advances. Published online July 24, 2024. doi:10.1182/bloodadvances.2023012549 2.        Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor (CAR) T cell immunotherapies modified to minimize burden on healthcare delivery system. FDA. June 26, 2024. Accessed July 23, 2024. https://tinyurl.com/2m284rjy

On this episode of Dementia Matters, Dr. Scott Roberts talks about disclosing genetic test results for APOE, a gene that can increase one's likelihood of developing Alzheimer's disease. While this information can be concerning, Dr. Roberts shares that it can empower individuals to take the necessary precautions to lower their risk of developing the disease. He discusses the Risk Evaluation and Education for Alzheimer's Disease (REVEAL) study, walks us through the APOE disclosure process and shares how it is evolving with the development of new Alzheimer's treatments. Guest: Scott Roberts, PhD, interim chair, professor of health behavior & health education, University of Michigan School of Public Health   Show Notes Read Dr. Roberts' article, “Genetic risk assessment for adult children of people with Alzheimer's disease: the Risk Evaluation and Education for Alzheimer's Disease (REVEAL) study,” on the SageJournals website. Decide if you're a fit forAPOE testing using Virginia Tech's ‘Gene Test or Not?' decision aid tool, mentioned at 17:00 in the episode. Learn more about Dr. Roberts on his University of Michigan profile. Learn more about APOE by listening to our episode, “DNA Is Not Your Destiny: Genetics and Alzheimer's Disease Risk,” with Dr. Corinne Engelman on our website. Read “WRAP data used in study finding a distinct, genetic form of Alzheimer's disease” on the Wisconsin Alzheimer's Institute (WAI) website.   Connect with us Find transcripts and more at our website. Email Dementia Matters: dementiamatters@medicine.wisc.edu Follow us on Facebook and Twitter. Subscribe to the Wisconsin Alzheimer's Disease Research Center's e-newsletter. Enjoy Dementia Matters? Consider making a gift to the Dementia Matters fund through the UW Initiative to End Alzheimer's. All donations go toward outreach and production.

The US Food and Drug Administration (FDA) implemented Risk Evaluation and Mitigation Strategy (REMS) programs to ensure benefits outweigh the safety risks of particular medications. With over 60 medications with REMS programs and varying requirements for each, operationalizing to comply with requirements can be challenging. In this podcast, we talk about some of those challenges and how to operationalize recommendations for those who routinely see these medications in practice, as well as for those who come across them sporadically.  The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

Shane and Tonya discuss the recent New York Times article about car companies selling data to insurance carriers, how that affects insurance rates, and how to have those conversations with clients.Learn more at iaforward.com, and follow IA Forward on LinkedIn, Facebook, and Instagram.

Welcome back to The Trip Report Podcast, a production of Beckley Waves, a Psychedelic Venture Studio.Today, I am speaking with Rick Doblin, founder and President of the Multidisciplinary Association for Psychedelic Studies (MAPS).December of last year was a milestone for Doblin and MAPS, as the organization submitted a New Drug Application for MDMA Assisted Therapy to the United States Food and Drug Administration.Then, in the first week of January, the MAPS Public Benefit Corp announced its rebranding to Lykos Therapeutics and a $100 million Series A financing.Needless to say, it has been a pivotal period in the organization's history and a watershed moment for the revival of psychedelic medicine, science, and policy.In February, the FDA accepted the application and granted a priority review, putting the decision timeline at August of this year.That's just around the corner.And so much is still up in the air—of course the big question—will the FDA grant approval? But also so many granular details that will have significant downstream effects on the commercial rollout, access, and cost.* What language will be on the drug label? * What will the Risk Evaluation and Mitigation Strategy entail? * How will patients be able to access the drug? * What will the FDA say about the role of therapy?Among others.So, I wanted to sit down with Rick to talk about it and get his perspective on the organization's evolution, the path ahead, and, most importantly, the many uncertainties that hang in the balance.In this conversation, we discuss:* The importance of therapy in conjunction with MDMA (and his loathing of the acronym MDMA-AT)* The many regulatory and bureaucratic details that go into the FDA's decision and subsequent commercial rollout, including:* Drug labeling* Therapist credentialing * Risk Evaluation and Mitigation Strategies* The negotiations he's led with the FDA over the last 20 years* Lykos' goal of getting MDMA-Assisted Therapy FDA approved and MAPS' goal of getting MDMA federally legalized* The role of therapist's first-hand experience with MDMA and the regulatory battle of ensuring legal access to this group* His future humanitarian and scientific plansAnd much more.And now I bring you my conversation with Rick Doblin.Listen to the episode on Substack, Spotify, Google or Apple.Credits:* Hosted by Zach Haigney * Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari* Find us at thetripreport.com* Follow us on Instagram, Twitter, LinkedIn and YouTubeTheme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.thetripreport.com

Listen to the Q&A between Bernard Walder, Giovanna Lurati Buse and Michelle Chew as they discuss the guideline “ESAIC focused guideline for the use of cardiac biomarkers in perioperative risk evaluation”, found in the December 2023 issue of the EJA.

Case Discussion 107 Answer: SCD risk and CMR in HCM

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In our final episode of 2023, Trevor Prince sits down with Tommy Nicholas, the Co-Founder and CEO of Alloy. Alloy is a platform that provides banks and FinTechs with a unified operating system for risk, fraud, and credit evaluation and monitoring in retail financial services. In this episode, Tommy discusses his background, Alloy's business model and what it took to scale the company, Tommy's outlook on Alloy and FinTech heading into 2024, and much more. About Tommy Nicholas: Tommy has served as the CEO of Alloy since co-founding the company in 2015. Prior to Alloy, was the Head of Product at Knox Payments, and spent time as a software developer. He was born and raised in Richmond, VA, and graduated from the University of Virginia, where he received a Bachelor's in History and African American Studies.

On June 29, 2023, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions to enable our podcast audience to listen to the sessions in this venue. The topic of this podcast is the panel discussion on the U.S. Environmental Protection Agency's (EPA) risk evaluation process under Lautenberg. The panel discussed various aspects of EPA's risk evaluation of chemical substances under Toxic Substances Control Act (TSCA) Section 6. The panel experts touch upon crucially important issues, including EPA's potential use of European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) data, EPA's use of new approach methodologies (NAM), the effectiveness of a “whole chemical approach” to risk determinations, the incorporation of cumulative risk assessment (CRA) approaches, and  much, much more. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

Here Desiree Chappell and Andy Cumpstey speak with Michelle Chew, Academic Chair and Professor in Anaesthesiology, Intensive Care and Acute Care at Linköping University Hospital, Sweden and Giovanna Luratibuse, consultant and anesthesiology Professor at the University Hospital Düsseldorf, Germany. For more on this topic - and the check out the guidelines - go to: https://journals.lww.com/ejanaesthesiology/pages/default.aspx Or straight to the guidelines here: https://journals.lww.com/ejanaesthesiology/Fulltext/9900/ESAIC_focused_guideline_for_the_use_of_cardiac.98.aspx?WT.mc_id=HPxADx20100319xMP This piece was recorded while TopMedTalk were at this year's annual conference of The European Society of Anaesthesiology and Intensive Care (ESAIC); Euroanesthesia 2023. We had a presence there at the GE Healthcare stand. ESAIC is the leading European Organisation for Anaesthesia, Intensive Care, Pain and Perioperative Medicine. TopMedTalk is proud to continue to bring you coverage of their annual conference. For more information on the work ESIAC do check out their website here: https://www.esaic.org/event/euroanaesthesia-2023/

We welcome back Kim Witczak, Consumer Representative on the FDA Advisory committee, to share her insights gained from 20-years of advocacy work and experience in advertising and marketing. Her extensive experience has not only honed her skills but also equipped her with the ability to connect the dots, revealing the complex relationships between Washington, the FDA, Big Pharma, Medical Schools and the healthcare system. Kim Witczak

Ever thought about the crucial role culture plays in the pharmaceutical and biotech industries? What if we told you it's not just about hiring quality people but also about cultivating an atmosphere of strong communication, compliance, and a deep understanding of roles and responsibilities? Welcome to season two of Queens of Quality. In our latest episode, we dissect this complex subject, peeling off the layers that often lead to group dynamics and group thinking pitfalls. We share some insights on creating a culture that doesn't just dwell on 'do what I say' but promotes trust and objectivity. Did you know the importance of humor in maintaining your sanity amidst the daily grind of hard work? We couldn't agree more! Balancing the seriousness of the work with our mental well-being is an art that needs mastering. Tune in as we discuss the art of decision-making, demonstrating our work outcomes, and proactively mitigating risks using a Risk Evaluation and Mitigation Strategy (REMS). As we delve deeper into this conversation, we also touch upon the importance of evaluating potential employers and the significance of quality control in preserving your future. Join us for insights, laughter, and shared experiences on this journey toward cultivating a culture of quality.Tune in! During this episode, you will learn about;(0:00:31) - Start of the show and Introduction of Hosts(0:01:00) - Overview of Season Two Topics(0:03:00) - Discussion on Culture of Quality(0:11:24) - The Role of Humor in the Workplace(0:16:27) - The Importance of Conservative Decision-Making and REMS(0:21:57) - The Art of Interviewing Potential Employers(0:27:03) - Maintaining Quality Control and Safeguarding Future Love the show? Subscribe, Rate, Review, Like, and Share! Let's Connect!Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com

On this week's episode, Scott was joined by Robert Kirk for a discussion on data. Robert is a seasoned financial industry expert with over 30 years of experience, serves as the Founder and CEO of InterGen Data, Inc., a company revolutionizing the banking, financial services, insurance, and home healthcare industries through the adoption of its proprietary and patent-pending Life Stage/Life Event prediction and analysis data.  With an impressive track record in leadership roles such as Chief Information Officer at 1st Global Research & Consulting and Principal Consultant at Mphasis (a Blackstone Company), Rob has consistently demonstrated his ability to drive innovation, streamline operations, and foster strategic partnerships. As a visionary with a strong background in technology, data, and wealth management, Rob has led transformative initiatives at companies like Penson Financial Services and Southwest Securities, Inc. His extensive experience and proven expertise in wealth management, financial services, and clearance and settlement make him the driving force behind InterGen Data's disruption of the financial industry.In this episode you will learn the following: How and why Robert started InterGen DataHow to utilize data in financial and insurance planningThe explosion of AI and how it helps to analyze data to determine what's relevantHow insurance companies are utilizing data for client policy predictions How do you help clients effectively plan for their finances, healthcare, or insurance needs? By showing them the future.Connect with Scott on LinkedInConnect with  Robert on LinkedInFor more on The Optimized Advisor Podcast click here  For more on InterGen Data click hereFollow us on LinkedInFollow us on InstagramFollow us on Facebook**This is the Optimized Advisor Podcast, where we focus on optimizing the wellbeing and best practices of insurance and financial professionals. Our objective is to help you optimize your life, optimize your profession, and learn from other optimized advisors. If you have questions or would like to be a featured guest, email us at optimizedadvisor@mailpcwest.com

Cybersecurity has become increasingly important in recent years, with cyber-related crime on the rise. This had made cybersecurity, risk evaluation, and mitigation increasingly important, particularly for companies wanting to reduce their vulnerabilities to cyber risks and refine their insurance offerings. Meng Sun, a PhD Candidate at Simon Fraser University and Senior data scientist investigating risk management in life and general insurance, has created a qualitative and quantitative analyses to consider time series, type of institution, and geographic dependency, particularly in relation to US markets. Ms Sun aims to share her findings of cyber risk to provide risk mitigation insights to different kinds of organisations. Find out more about Ms Sun's research via her researcher profile, Google Scholar, and LinkedIn. Read the original research: https://www.mdpi.com/2227-9091/10/12/224  

Title: Episode 60: FSC Check – how FSC will use risk evaluation as part of the certification process Author(s): Worm, Loa Dalgard Description: In this episode we dive deep into the world of safeguarding FSCs integrity and ensuring that the businesses and organisations around the world working with FSC are the good guys. In a world where sustainable transformation is the norm and prerequisite for many business transactions and license to operate, getting certified by FSC is increasingly attractive to companies around the world. This is a positive thing. But it also means that some might want to join FSC, who do not necessarily fit the profile of companies, we want to work with. They might be deforesting forest areas in other parts of their business or violating human or workers' rights. Destructive activities such as these are a part of a longer list of actions that are in the FSC system called “unacceptable activities”. Today we are going to talk about a new tool in FSC, which will help us identify the if a company that wants to get certified, or an applicant member has been involved in an unacceptable activity or not, based on which FSC will allow them to enter the FSC system or reject their application. To help me understand more, I've invited Saija Hotti, Program Manager for Operations and Development at FSC.

Recently, the Food and Drug Administration announced that retail pharmacies in the US would be able to receive certification to dispense medication abortion drugs. Greer Donley, Associate Professor at the University of Pittsburgh School of Law, sits down to talk with us about the FDA's recent changes to regulations around medication abortion, including the current status of access, possible challenges, and how far these new changes really go.   Since the FDA approval of mifepristone—one of two medications currently used in a medication abortion—in 2000, access has been harshly regulated. Usually, FDA-approved medications are easily prescribed by licensed providers and dispensed at a pharmacy, but mifepristone faces additional barriers, including a Risk Evaluation and Mitigation Strategies (REMS) protocol. REMS restrictions are reserved for dangerous medication, and include a certification process for the clinician, requires that the medication be dispensed in person in the clinic, hospital, or medical office, and that patients must fill out a consent form. Every major medical association and major expert in the field has branded REMS restrictions for mifepristone completely unnecessary, as it is an incredibly safe drug to take—safer than Penicillin, Viagra, and Tylenol.  During the pandemic, the FDA temporarily lifted the in-person restriction, as making people physically go pick-up medication abortion pills put them at unnecessary risk of COVID-19 transmission. The Supreme Court overturned this decision, but the Biden administration's newly elected FDA Commissioner, in response, announced that they would not enforce the in-person dispensing requirement completely. A few weeks ago, the FDA began formalizing this announcement, laying out the reversal of in-person dispensing requirement and the allowance of some pharmacies to dispense medication abortion after a certification process. These changes will not have any effect in states that currently ban abortion, as state laws will stop pharmacies and prescribers from dispensing mifepristone. Even with the formalization of this rule, it is unclear how many pharmacies will go through the certification process to be able to dispense the drug. In addition, once pharmacies do become certified, patients will still need to find a certified provider to write than a prescription, and states will still have to follow state laws that restrict abortion. There is a current legal challenge working its way through district court which would ban access to mifepristone. This case was incited by an anti-abortion group suing the FDA in Texas in an effort to revive the Comstock Act; this act, passed near 150 years ago, bans mailing “obscene materials,” the definition of which is being applied to abortion pills. This lawsuit is completely meritless, yet it is still making its way through district court where the only judges are anti-abortion Trump-appointees. In the U.S., more than 50 percent of abortions are medication abortion, and with Dobbs' disruption of abortion care, this will be incredibly harmful to access post-Roe. Support the showFollow Us on Social: Twitter: @rePROsFightBack Instagram: @reprosfbFacebook: rePROs Fight Back Email us: jennie@reprosfightback.comRate and Review on Apple PodcastThanks for listening & keep fighting back!

In this session recorded at DPHARM 2021, Merck shares about their proprietary Site Monitoring and Reporting Tool (SMART), an iOS Apple iPad technology that enables “monitoring and deviation management” before, during and after COVID-19. Merck talks about how they got SMART. Merck developed a real-time “scorecard” for sites called Site Health Check, which allows them to see how they are performing in absolute and relative terms compared to other sites. Merck addresses how this really helped in COVID-19. Merck has engaged in project RESTART to help sites and to lock databases (~300 locked in 2020 and none missed in 2020 and 2021). Merck shares with the DPHARM audience how this worked.  Speakers Andrew Onikepe, Director, Monitoring Excellence – North America, Global Clinical Trial Operations (GCTO), MerckMerle Schneider, Director, Monitoring Excellence Innovation, MerckKatherine Taylor, MBA, Head, Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Global Clinical Trial Operations (GCTO), Merck

Join in another fantastic episode with your hosts, Jennifer and Michelleanne. In today's episode, we talk about Risk Evaluation and Mitigation Strategy (REMS). We talk about the history of Thalidomide and why REMS closely monitors it. Moreover, we discuss the different pieces of REMS and the difference between Single REMS & Shared REMS.Additionally, we talk about the difference between Pharmacovigilance (PV) & REMS, The REMS Industry Consortium (RIC), and how to get started with a REMS program. Tune in! During this episode, you will learn about;[00:30] Episode introduction[00:37] Today's theme; Risk Evaluation and Mitigation Strategy (REMS) [01:18] When was REMS started?[01:44] The history of Thalidomide and why REMS closely monitors it[07:03] Single REMS vs Shared REMS [11:20] Risk piece in REMS program [12:21] Evaluation piece in REMS program [17:35] The difference between Pharmacovigilance (PV) and REMS[18:35] Mitigation piece in REMS program [21:44] The REMS Industry Consortium (RIC) [25:28] How to get started with a REMS program[26:55] What to expect in the next episode[27:41] How to connect with us  Remember to Subscribe, Rate, Review, Like, and Share!Let's Connect!Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com

Anybody love a good bulk buy? Me too! Today's tip - buy those maintenance drugs in bulk! Think beyond the 30, even 90-day fill if you can. Note that not every state allows longer that 90 day prescriptions - please keep that in mind when asking your pharmacist if you may buy in bulk! Also, some products can only be purchased at a smaller quantity due to safety or Risk Evaluation & Mitigation Strategies (REMS) programs. --- Support this podcast: https://anchor.fm/theedutainer/support

In this episode of the Psychedelic Therapy Frontiers podcast, Dr. Steve Thayer and Dr. Reid Robison are joined again by Dr. Paul Thielking.  Paul is a psychiatrist, palliative care physician, zen practitioner, and the chief scientific officer at Novamind. Paul joins the show to talk about psychedelic clinical trials. (2:15) Introduction to the topic(4:11) Cedar Clinical Research(4:45) What is a clinical trial?(10:42) The unique challenges of psychedelic clinical trials and regulating psychedelic-assisted psychotherapy(15:09) Risk Evaluation and Mitigation Strategy (REMS)(18:06) The therapy part of psychedelic-assisted therapy(24:13) How important is integration support after psychedelic experience(26:33) The resources required to do psychedelic-assisted therapy(29:55) The challenges of training enough therapists to do psychedelic-assisted therapy (36:11) Psychedelic medicine accessibility and scaleability (39:25) Placebo-controlled double-blind psychedelic studies (44:02) Handling and accounting for disappointment when a trial participant gets the placebo(49:11) Investigator initiated studies(52:28) Compassionate use and expanded access(55:45) What types of psychedelics are being studied in clinical trialsEmail us questions and feedback at psychfrontiers@novamind.ca Learn more about our podcast at https://www.psychedelictherapyfrontiers.com/Learn more about Novamind at https://www.novamind.ca/Follow us on Instagram: https://www.instagram.com/drstevethayer/https://www.instagram.com/innerspacedoctor/https://www.instagram.com/novamind_inc/Disclaimer: The content of this podcast does not constitute medical advice or mental health treatment. Consult with a medical/mental health professional if you believe you are in need of mental health treatment.

What a captivating name.....Thiazolidindiones!! Besides understanding how these drugs work, we learn what a Risk Evaluation and Mitigation Strategy (REMS) program is, and why drugs are placed on this program.

Tracy Dixon, PsychD and Carissa Bravo, PsychD, Providence Behavioral Health Providers CME Credit Available for all Providence Providers In order to claim CME credit, please click on the following link: https://forms.office.com/r/eibNdBpFLW (or copy/paste into your browser) Accreditation Statement: Providence Oregon Region designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 creditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Providence Oregon Region is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Planning Committee & Faculty Disclosure: The Planning Committee and faculty have no relevant financial relationships with ineligible companies interests to disclose. Original Date: February 17, 2022 End Date: February 17, 2023.

Tracy Dixon, PsychD and Carissa Bravo, PsychD, Providence Behavioral Health Providers CME Credit Available for all Providence Providers In order to claim CME credit, please click on the following link: https://forms.office.com/r/eibNdBpFLW (or copy/paste into your browser) Accreditation Statement: Providence Oregon Region designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 creditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Providence Oregon Region is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Planning Committee & Faculty Disclosure: The Planning Committee and faculty have no relevant financial relationships with ineligible companies interests to disclose. Original Date: February 17, 2022 End Date: February 17, 2023.

When the Food and Drug Administration (FDA) approved mifepristone--the first of two drugs used in a medication abortion-- in 2000, the approval process came with a myriad of restrictions. Kirsten Moore, creator and director of the Expanding Medication Abortion Access (EMAA) Project, sits down to talk with us about the evolution of restrictions on medication abortion over the past 22 years, as well as the future of medication abortion access. In the mid-2000s, these restrictions were folded into an FDA program called Risk Evaluation and Mitigation Strategies (REMS). These restrictions included a certification process for the clinician, requires that the medication be dispensed in person in the clinic, hospital, or medical office, and patients must fill out a consent form. During the pandemic, the FDA issued guidance for medications subject to REMS, easing restrictions on providers and patients—but medications requiring in-person dispersal was not included. The American College of Obstetricians and Gynecologists (ACOG) sued the FDA, leading to a short period of time in 2020 when providers were able to consult with patients and prescribe medication abortion care through telemedicine and the mail. In January of 2021, the Supreme Court shut these abilities down. Still, in spring of 2021, the FDA announced that they would re-consider the current REMS restrictions. In December of 2021, the FDA announced the removal of the in-person distribution requirement for mifepristone and allowing in-person and mail-order pharmacy distribution. Unfortunately, expanded medication abortion access will, like many reproductive health services, be dependent on where you live. At this moment, 19 states prohibit the use of telehealth for abortion care (the number of states may rise to 26 depending on the future of Roe v. Wade). Many patients who are seeking an abortion are already facing structural, financial, and logistical barriers that make accessing this care extremely difficult to begin with. Even so, the FDA's lifting of unnecessary restrictions on medication abortion dismantles one less barrier to care for many. LinksThe EMAA Project on FacebookThe EMAA Project on TwitterBlog post- Supporting a Friend's Abortion At Home Take Action Follow the EMAA project on Facebook and Twitter here. Stay engaged in the fight to reduce barriers to medication abortion in individual states, and continue to talk about medication abortion as an option! Many people aren't aware of it or know little about it, despite the fact that it's an extremely safe and effective way of ending a pregnancy.  You can also support friends, family members, or loved ones during their medication abortion by bringing them a care basket, joining them to watch movies while they complete their abortion, or simply validating their experiences. Learn more in Caitlin Blunnie's blog post here!Support the show (https://www.reprosfightback.com/take-action#donate)

Mitigating the Impacts of Climate Change. The host for this show is Jay Fidell. The guest is Sanford Murata. Sanford Murata, real estate and planning professional, discusses the evaluation of flood risk from the Ala Wai Canal, and plans to mitigate that risk and otherwise mitigate the impacts of climate change and the demands of development and affordable housing in Honolulu. The ThinkTech YouTube Playlist for this show is https://www.youtube.com/playlist?list=PLQpkwcNJny6mAjbhHpq-LyAm9pcuN3zJ

Contraception 2021 Sep 20;[EPub Ahead of Print], D Grossman, S Raifman, N Morris, A Arena, L Bachrach, J Beaman, MA Biggs, C Hannum, S Ho, EB Schwarz, M GoldSTUDY DESIGNThis is an interim analysis of an ongoing prospective cohort study conducted at five sites. Clinicians assessed patients in clinic and, if they were eligible for medication abortion and ≤63 days' gestation, electronically sent prescriptions for mifepristone 200 mg orally and misoprostol 800 mcg buccally to a mail-order pharmacy, which shipped medications for next-day delivery. Participants completed surveys three and 14 days after enrollment, and we abstracted medical chart data for this interim analysis.  In this prospective cohort study, researchers estimated the effectiveness, feasibility, and acceptability of medication abortion with mifepristone dispensed by a mail-order pharmacy with next-day delivery after in-person clinical assessment. The researchers found that complete medication abortion occurred for 96.9% of participants; 88.4% reported being very satisfied receiving medications by mail, and 89.6% said they would use the mail-order service again if needed. Of the 4.9% who experienced adverse events, none were related to mail-order dispensing. This research suggests that mail-order pharmacy dispensing of mifepristone is effective and acceptable to patients, providing further evidence that the in-person dispensing requirement for this medication should be removed.  IMPLICATIONSThe in-person dispensing requirement for mifepristone, codified in the drug's Risk Evaluation and Mitigation Strategy, should be removed.      Stevens SM et al. Antithrombotic therapy for VTE disease: Second update of the CHEST Guideline and Expert Panel Report. Chest 2021 Aug 2; [e-pub]. (https://doi.org/10.1016/j.chest.2021.07.055)  The ninth edition of the CHEST Clinical Practice Guidelines for managing venous thromboembolism (VTE) — published in 2012 and updated in 2016 — now has a second update, which addresses 14 clinical questions and offers 32 guidance statements for clinicians who manage patients with VTE. The 2012 guideline (Chest 2012; 141:Suppl:e419S and the 2016 update (NEJM JW Emerg Med Feb 2016 and Chest 2016; 149:315) both are publicly available.Key Recommendations Patients with isolated subsegmental pulmonary embolism (PE): Rule out proximal deep venous thrombosis (e.g., with ultrasonography). If risk for recurrent VTE is low, surveillance is recommended over anticoagulation. If risk for recurrent VTE is high, anticoagulation is recommended. (Weak recommendation, low-certainty evidence) Patients with incidentally discovered asymptomatic PE (other than isolated subsegmental PE): Same initial and long-term anticoagulation that patients with symptomatic PE receive should be used. (Weak recommendation, moderate-certainty evidence) Patients with cancer-associated VTE: Direct-acting oral anticoagulants (DOACs; i.e., apixaban, edoxaban, or rivaroxaban) should be used for the treatment phase of therapy (strong recommendation, moderate-certainty evidence). Caveat: for patients with luminal gastrointestinal malignancies, apixaban or low-molecular-weight heparin is preferred to reduce bleeding risk. Patients with antiphospholipid syndrome: Warfarin (target international normalized ratio, 2.5) is recommended over DOAC therapy during the treatment phase for VTE. (Weak recommendation, low-certainty evidence) Catheter-assisted mechanical thrombectomy: Recommended for patients with PE and hypotension who also have high bleeding risk, failed systemic thrombolysis, or shock that is likely to lead to death before systemic thrombolysis can take effect. (Weak recommendation, low-certainty evidence) Initial anticoagulation setting: Outpatient treatment is recommended over hospitalization in patients with low-risk PE, if access to medications and outpatient care is available. (Strong recommendation, low-certainty evidence) Treatment-phase anticoagulants: DOACs are recommended over warfarin. (Strong recommendation, moderate-certainty evidence) Extended-phase therapy (beyond 3 months) for VTE: Extended anticoagulation should be offered to patients with unprovoked VTE — i.e., with no major or minor transient risk factors. Risk for recurrent VTE, risk for bleeding, and patients' values and preferences should be considered in decisions about extended anticoagulation therapy. (Strong recommendation, moderate-certainty evidence) Low-dose apixaban or rivaroxaban is recommended over full doses of these agents. (Weak recommendation, very low-certainty evidence) Aspirin is recommended for patients who are stopping anticoagulation. (Weak recommendation, low-certainty evidence) Ingason AB et al. Rivaroxaban is associated with higher rates of gastrointestinal bleeding than other direct oral anticoagulants: A nationwide propensity score–weighted study. Ann Intern Med 2021 Oct 12; [e-pub]. (https://doi.org/10.7326/M21-1474) The study used icelands National databank to compare GI bleeding among almost 6000 patients receiving  apixaban, dabigatran, and rivaroxaban for the first time.  Patients were followed for 1-1/2 years and GI bleeding was verified by review of the medical records.  Once there was a propensity score analysis it was deemed that rivaroxaban had significantly high rates of minor and major gastrointestinal bleeding compared to apixaban with a number needed to treat of around 40 or 50.  However there was no difference between rivaroxaban and dabigatran.  I think this goes to what we have all seen and that the bleeding risk among most anticoagulate medications is not equal but unfortunately which medication the insurance companies will pay for it is also not equal.  However if your patient is at large risk for GI bleed likely should consider not using rivaroxaban                     Chen R et al. Comparative first-line effectiveness and safety of ACE (angiotensin-converting enzyme) inhibitors and angiotensin receptor blockers: A multinational cohort study. Hypertension 2021 Sep; 78:591. (https://doi.org/10.1161/HYPERTENSIONAHA.120.16667) In this retrospective study of patients who initiated monotherapy for hypertension, researchers used eight large observational databases to compare outcomes for 2.3 million new users of ACE inhibitors and nearly 700,000 new users of ARBs.  Myocardial infarction, stroke, and heart failure occurred with similar frequency in the two groups, after extensive adjustment for demographic and clinical variables. However, cough, angioedema, pancreatitis, and gastrointestinal bleeding occurred significantly more often in ACE-inhibitor users than in ARB users.            Long-Term Risk for Major Bleeding During Extended Oral Anticoagulant Therapy for First Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 174, No 10 (acpjournals.org) What happens if you extend anticoagulation past the 3 to 6 months for an individual who has a first unprovoked venous thromboembolism.  Often this is a debate in the clinical practice of while you seem low risk so maybe we should discontinue this anticoagulation or well you had his lab value is off to me we should continue anticoagulation.  The scary thing is you do not want to discontinue the anticoagulation and the may have a massive saddle embolism and die!  It is easy to start a medication but it is always so hard to stop the medication.  this study looked at that exact question --it looked at 14 randomized control trials and 13 cohort studies with just over 17,000 patients taking either vitamin K antagonist or DOACs.  The patient had to have received a minimum of at least 9 months of anticoagulation in order to be enrolled in the final analysis and they looked at patients who had had extended anticoagulation up to 5 years.In the end the incidence of major bleeding with warfarin was 1.7 events per year per 100 patients and much lower with the DOACs at 1.12 events per year per 100 people.  While that does not sound like a lot with the newer agents he has remember that is only after 1 year if he looked at the 5-year cumulative incidence of major bleeding for those individuals on either warfarin or a DOAC it was 6.3% which is certainly at significant risk of bleeding especially when you consider that the case fatality rate was 8.3% expirationThat was a whole bunch of numbers but basically I guess with this meta-analysis is really saying is that the current recommendations for anticoagulation after a unprovoked venous thromboembolism are 3 to 6 months and if you are going to extend that out to 9 months or a year or even up to 5 years he better have a darn good reason given that the eventual rates of bleeding are so high and the mortality rate from those bleeds are also so high.  

@rundmcd is back to talk about evaluating risk! (AKA "Dave tells me the 3 pitchers I'm allowed to draft this year!") 11:20 Carlos Rodon 22:05 Jacob deGrom 31:15 Shane Bieber 38:50 Chris Sale 44:15 Luis Severino 54:05 Clevinger vs Verlander 1:14:43 Clayton Kershaw, and Dinelson Lamet "When I see PRP, I'm out." - Dave 1:27:30 Zac Gallen Find us on Twitter! He's @rundmcd, and I'm @commonsensefbb.

Listen Now Preventing adult heart attacks in early childhood? Don Wilson, M.D., explains why it's absolutely within REACH. Children with high cholesterol, especially those who have a genetic cause, such as familial hypercholesterolemia, also know as fH, are at a higher risk for developing premature heart disease, such as heart attack or stroke as they become adults. At the forefront of developing guidelines for lowering this risk, Dr. Wilson details how the Risk Evaluation to Achieve Cardiovascular Heath, or REACH, clinic at Cook Children's is putting those guidelines to work and changing the outcomes for these in the future, and saving the lives of parents today. Meet the speaker Dr. Don Wilson Related InformationRisk Evaluation to Achieve Cardiovascular Health (REACH) Clinic Diabetes Program Endocrinology Program They're Active, Eat Healthy, and Have High Cholesterol-Why? Harper's Story Kids at Risk of Smoke Exposure in Smoke-Free Areas? A Simple Blood Test Could Save Your Child's Life The Unique Risks of Being a Woman with Diabetes Number of Children and Adolescents Who are Obese 10 Times Higher than 40 Years Ago Transcript: 00:00:03 Host: Hello, and welcome to Cook Children's Doc Talk. Today we're talking with Dr. Don Wilson about genetic dyslipidemia, and cardiovascular disease. But first, here's just a little about Dr. Wilson. He is board certified in pediatrics, pediatric endocrinology and clinical lipidology. He is the founder and currently the medical director of Cook Children's REACH program, one of the first cardiovascular risk assessment clinics for children and adolescents in the nation. Dr. Wilson is a fellow of the National Lipid Association and an associate editor for The Journal of Clinical Lipidology and a member of the

This week's Chemical Watch News Podcast sees North America managing editor Terry Hyland, Asia desk editor David Macfarlane and emerging markets reporter Ginger Hervey join global managing editor Kate Lowe to discuss a selection of the latest developments in chemicals management.

Commentary by Dr. Valentin Fuster

Welcome to this version of the Just Start Real Estate Podcast! I am excited about this new feature that I am going to be bringing you on Thursdays - the replay of each week's Facebook Live Question and Answer session. I just started doing these live forums last month and they are going so well and I am getting such great feedback and questions, I thought I would share them here on the podcast. Especially for those people that are unable to join us live, this will provide an opportunity to hear the awesome questions I am fielding about business, taking risks, real estate, and so much more! Some of the questions have been very real estate specific, but others have been general business questions, like asking about overcoming fear in order to get started and how to successfully scale. I have also received more personal questions like how I decided real estate investing was right for me and the steps I took to get my business off the ground. This was the first live Q&A that I did on April 7th and each week on Thursday we will offer you another chance to take advantage of listening to the answers to our guests' fabulous and compelling questions! Don't miss this new episode of the Just Start Real Estate Podcast! Notable Quotes: “Convincing yourself is not something you do when you are evaluating a specific property that you want to invest in.” “How do you triangulate the truth in any situation? You ask a lot of different sources, right?” “Another great idea is to join a mastermind because now you are in a curated community of people who are doing great things in their businesses, and coming together to share that.” “How long will the market stay hot? Short answer - nobody knows!” “If you want to be a real estate investor, be a real estate investor. I don't care what the market cycle is. You have to be aware of where you are in the market cycle, but it doesn't mean that you wait.” “I regret every risk that I wanted to take, but didn't take, because the reason I didn't take it, in almost every case, was because I was afraid.” “Time is something that people blame a lot for not taking a risk.” Links: Blitzar Capital Investing Opportunity 7 Figure Flipping Return on Investments Just Start Real Estate JSRE on Facebook Mike on Facebook Mike on Instagram Mike on LinkedIn Mike on Twitter Level Jumping: How I Grew My Business to Over $1 Million in Profits in 12 Months

Welcome to this version of the Just Start Real Estate Podcast! I am excited about this new feature that I am going to be bringing you on Thursdays - the replay of each week’s Facebook Live Question and Answer session. I just started doing these live forums last month and they are going so well and I am getting such great feedback and questions, I thought I would share them here on the podcast. Especially for those people that are unable to join us live, this will provide an opportunity to hear the awesome questions I am fielding about business, taking risks, real estate, and so much more! Some of the questions have been very real estate specific, but others have been general business questions, like asking about overcoming fear in order to get started and how to successfully scale. I have also received more personal questions like how I decided real estate investing was right for me and the steps I took to get my business off the ground.   This was the first live Q&A that I did on April 7th and each week on Thursday we will offer you another chance to take advantage of listening to the answers to our guests’ fabulous and compelling questions! Don’t miss this new episode of the Just Start Real Estate Podcast! Notable Quotes:   “Convincing yourself is not something you do when you are evaluating a specific property that you want to invest in.”   “How do you triangulate the truth in any situation? You ask a lot of different sources, right?”   “Another great idea is to join a mastermind because now you are in a curated community of people who are doing great things in their businesses, and coming together to share that.”   “How long will the market stay hot? Short answer - nobody knows!”   “If you want to be a real estate investor, be a real estate investor. I don’t care what the market cycle is. You have to be aware of where you are in the market cycle, but it doesn’t mean that you wait.”   “I regret every risk that I wanted to take, but didn’t take, because the reason I didn’t take it, in almost every case, was because I was afraid.”   “Time is something that people blame a lot for not taking a risk.” Links: Blitzar Capital Investing Opportunity 7 Figure Flipping Return on Investments Just Start Real Estate JSRE on Facebook Mike on Facebook Mike on Instagram Mike on LinkedIn Mike on Twitter Level Jumping: How I Grew My Business to Over $1 Million in Profits in 12 Months

This edition of the Chemical Watch news podcast sees North America managing editor Terry Hyland, Asia desk editor David Macfarlane and Europe editor Luke Buxton join global managing editor Kate Lowe to discuss the latest developments in chemicals management across the globe.

Mazi VS is a Professional Sports Bettor, Handicapper, and featured on SpikeTv's "Cappers". Mazi VS is regarded as one of the elite Sports Betters of this era, having set numerous records for analyzing sports data. Today he is a consultant, providing powerful membership packages for anyone interested in making money in Sports. Currently Mazi is on a 14-1 Sports Betting Streak laying down 5-to-6-figure bets on every single wager. |MaziVs|-MaziPicks.com-@MaziVS-Youtube|JakeGallen|-Instagram-Twitter-Facebook-Linkedin|TimeStamps|0:00 - Introduction1:06 - Early Days of Sports Betting Career 4:32 - Mazi's Legendary Winning Percentage 7:37 - Clientele & Sports Packages 11:02 - Personal & Sports Strategy 14:51 - Risk Evaluation 17:30 - When will Vegas find some Normalcy?21:01 - Diversifying Assets 24:14 - Learning from Previous Ventures 26:02 - Navigating the Top Ranks of Society 32:04 - Materialism 34:03 - Childhood & Growing Up39:08 - Betting on Sports 45:30 - Vegas Sports Betting 49:24 - Sports Betting Community52:30 - Spike TV's "Cappers" 53:53 - 14-1 Winning Streak 58:10 - Where is Vegas headed? 1:01:41 - What does Las Vegas mean to you? LISTEN and SUBSCRIBE to the platform of your choice|-Apple Podcasts-Spotify-Google Podcasts-Amazon Podcasts-Youtube (VIDEO RECORDINGS)

Dr. Christina Francis has work with orphans in Romania and Burma and working for three years as the only Ob/Gyn at a mission hospital in rural Kenya. These experiences have prepared for her work with the American Association of Pro-life Obstetricians and Gynecologists (AAPLOG). On today’s episode, Mark discusses recent developments in Washington, DC and the work of AAPLOG. Topics include: What is AAPLOG’s response to all of President Biden's recent Executive Orders? What should we take away from the new polling regarding American’s views on abortion? How should we respond to the new medical abortion/FDA rules? During the COVID 19 crisis, the abortion cartel has moved to eliminate the Risk Evaluation and Mitigation strategies (REMs) currently in place for pill abortions to protect women’s lives. The abortion lobby wants the health and safety standards (REMs) to be dropped for the easy distribution of chemical abortion pills. We cannot allow that to happen! Pill abortions usually involve two drugs. The first, mifepristone (also called RU486) starves and suffocates the baby. After mifepristone is taken, the mother’s production of progesterone is blocked. This hormone is needed to stabilize the lining of the uterus. As the uterine lining breaks down, the baby’s flow of nourishment and oxygen is cut off, starving and suffocating her. The Mark Harrington Show is on Mark’s Facebook, Twitter, and YouTube accounts. Mark’s show is broadcast in Columbus, OH (WRFD) 880am and (WTOH) 98.9FM, Cincinnati, OH (WCVX) 1160am, and Huntington, WV (WEMM) FM 107.9. The podcast is available on Apple Podcasts, Youtube, Periscope, Podbean, Google Podcasts, Spotify, Stitcher, YouTube, Overcast, and RadioPublic as well as on Mark’s flagship website: MarkHarrington.org  Facebook Personal - https://www.facebook.com/MarkCreatedEqual Facebook Page - https://www.facebook.com/TheMarkHarringtonShow/ Youtube Channel - https://www.youtube.com/channel/UC2kM_Q0sgCk9iVWAg8HNSFQ Twitter - https://twitter.com/mharringtonlive iTunes – https://itunes.apple.com/us/podcast/activist-radio-mark-harrington/id827982678 Google Play - https://play.google.com/music/listen?u=0#/ps/Ii2i6elyevshicbfmc5263zq2ga Website - https://markharrington.org Podbean - https://createdequal.podbean.com

In 2013, Texas implemented a slew of laws targeting abortion providers, shuttering over half of the state’s 40-some clinics overnight. The founder, CEO, and president of one such clinic, Amy Hagstrom Miller of Whole Woman’s Health, felt she had no option other than to sue the state to protect Texans’ right to choose. Still, as the now-landmark case Whole Woman's Health v. Hellerstedt wound its way through the federal court system, she was commonly asked the question: “Are you ready to risk the abortion rights of the whole country?” Bringing a case to the Supreme Court can lead to a Roe v. Wade-level decision — expanding rights for the entire nation — or the opposite. Nine years later, and with three reproductive rights cases currently in the federal court system, Hagstrom Miller finds herself in a situation with similarly high stakes. Though the Supreme Court said access to safe, legal abortions was a constitutional right 48 years ago, the anti-choice movement has steadily chipped away at the protections enshrined in Roe through restrictions and bans. The October SCOTUS confirmation of Justice Amy Coney Barrett, who is publicly anti-choice, was another blow to the reproductive rights movement, advocates said at the time. Says Hagstrom Miller, “You have to ask, ‘What advancements or rollbacks could happen?’” if the court rules one way or the other. But while bringing cases to SCOTUS was one of the only ways to protect national access under President Trump and a Republican-dominated Congress, a lot has changed in just three months. With the inauguration of President Joe Biden in the bag, pro-choice groups are gearing up to not just preserve the status quo, but expand abortion access — and rights — nationwide. “We’ve long known that the promise of Roe v. Wade was never real for working families in America,” Kelsey Ryland, co-director of All* Above All, a reproductive justice policy and strategy organization, tells Bustle. That’s why, she adds, now’s the time to “re-imagine” what Roe can do for people. “The courts are one piece of protecting access to abortion care, but they’re not our saving grace.” Below, four reproductive rights advocates explain what their biggest priorities are for the next four years. A major first step to expanding reproductive health care access in the United States independent of the court system would be repealing the Hyde Amendment, the annual budget bill rider that bars federal funds from paying for abortions. Under Hyde, people enrolled in Medicaid can’t use that health insurance for terminating a pregnancy, except in limited cases. This budget detail keeps the poorest Americans from receiving the same health care that their wealthier, privately insured peers have. Without insurance coverage, a first-trimester abortion costs about $500 in the United States just for the procedure; many clinics charge up to $250 in additional fees. The Biden administration has pledged to remove abortion coverage bans like Hyde from the budget, and a slim Democratic majority in both the House and Senate mean that it’s possible. But Ryland stresses that Hyde is just one piece of the puzzle. Earlier this month, All* Above All released a policy proposal that would holistically address how economic marginalization keeps people from getting comprehensive reproductive care. In addition to ending Hyde, the proposal points to raising the federal minimum wage to $15 an hour, ending tipped wages, protecting essential workers from deportation, and including low-wage workers in economic recovery efforts as actions the Biden-Harris administration can take in their first 100 days. “We have a great opportunity with the new administration and we’re really calling on the Biden-Harris administration to build back bolder,” Ryland says. “This is what we mean when we say that Roe was never enough. People need comprehensive and bold solutions to thrive and get the care they need.” Yamani Hernandez, the executive director of the National Network of Abortion Funds, echoes the need for Hyde repeal, but adds that there are many more costs that go into terminating a pregnancy. That’s why Hernandez’s organization has focused their past year on implementing a process to pool together funds, in preparation for whatever changes SCOTUS’s conservative supermajority might bring. Abortion funds help people afford both the procedure and associated expenses, like lodging, gas money, or child care. Hernandez explains that most funds aren’t able to pay for the full cost of an abortion for every person who calls. Generally, they’ll make a pledge of a certain dollar amount, and then refer the patient to other funds that might be able to help contribute the rest, so that the patient effectively crowdfunds their abortion. “We want to close that gap so people don’t have to call around to five different funds to get $50 here, $200 there,” says Hernandez. “On average, an abortion fund is able to fund about 1 in 4 people who call. We want to raise enough money to make those budgets higher.” The fund pooling program is now being piloted in certain regions of the country. The patient gets matched with a full-time staff case manager who will follow them throughout the process, taking the work of calling different funds off their plates. The Supreme Court's conservative supermajority undertook its first decision on abortion access in early January, when it approved a Trump administration request to reinstate restrictions on medication abortion that had been temporarily lifted because of the pandemic. Now, patients have to pick up mifepristone in-person (even though you take it at home), rather than have it mailed to them. Decisions like these explain why Kirsten Moore, the director of the Expanding Medication Abortion Access (EMAA) Project, has always focused on swaying Food & Drug Administration (FDA) policy, rather than trying to make change through legislation. Ultimately, it comes down to one FDA program, called Risk Evaluation and Mitigation Strategies (REMS), that regulates high-risk drugs like chemo medication to ensure they’re used safely. Mifepristone, however, is safer to take than a Tylenol, and unlike chemo drugs, is taken at home. “The Biden-Harris administration needs to speak up early and indicate their concern with the Supreme Court decision … [and] encourage the FDA to undertake a full review of the REMS,” Moore says. She hopes that without fear of pushback from the Trump administration about mifepristone’s regulations, the FDA will be ready to re-evaluate how patients can get this medication. Another crucial way to work around the Supreme Court? Change hearts and minds on the ground. “If we could have a shift in Texas like what has happened in Georgia, we could stop these laws from getting into the court system altogether,” says Hagstrom Miller. “It’s a lot cheaper to block a law from being passed in the first place than to block a law from going into effect [...] and that would be more powerful and more long-standing than any given court case.” Rachel Rebouché, the associate dean of research and James E. Beasley Professor of Law at Temple University, adds that the pandemic has changed how people have become accustomed to seeking out care. “Virtual clinics, online pharmacies, patients having medication abortion mailed to them — this all is about to become even more important now” that the FDA restrictions on mailing medication abortion pills are back in place, but the pandemic continues on. Rebouché is optimistic that no matter what policy changes get made, patients and providers will step in to fill the gaps. “There will become abortion markets that try to meet the needs of abortion deserts. That will have costs. People will travel. Self-managed abortion will jump and there will be consequences. But there will also likely be [financial] incentives to build out ways to support these markets, and I do think that’s where people are looking right now,” she says. “If you can’t rely on the Supreme Court and the Constitution for protection, then state regulations, federal actions, informal networks, and service infrastructure has to be the way to go.”

In this edition of the Chemical Watch Podcast editorial director Geraint Roberts, North America managing editor Terry Hyland and emerging markets reporter Ginger Hervey join global managing editor Kate Lowe to discuss three stories from the week. Firstly we discuss the European Commission's chemicals strategy for sustainability, due to be published this week, which has been the subject of fierce debate on key policy areas but is now expected to retain almost all of the policy actions originally proposed by DG Environment. Next we look at the decision of the US EPA to grant a request from a group of six manufacturers to conduct a TSCA risk evaluation for octamethylcyclotetrasiloxane (D4), setting the stage for the review of the cyclo-siloxane to begin before the end of the year. And finally, following a week that should have seen representatives from governments, intergovernmental organisations and NGOs from across the world gather in the German city of Bonn to decide the future of the UN’s chemicals programme, we ask how participants in the global talks are tackling the remaining vital issues.

Minimising the risk of roadside crashes is important in reducing the number of fatalities and serious injuries on our roads. The recently updated Part 6 of the Austroads Guide to Road Design includes a new method to determine the risk associated with roadside crashes and to identify where risk mitigation treatments are required on urban and rural road networks. The approach establishes a Network Roadside Risk Threshold (NRRIT) which consistently directs the locations for treatments within projects. This webinar, presented by Peter Ellis and Rod Troutbeck on 6 October 2020, describes the procedure's background in detail explaining the concepts and research behind it. The presentation slides can be downloaded from the supporting documents tab after logging in.

Minimising the risk of roadside crashes is important in reducing the number of fatalities and serious injuries on our roads. The recently updated Part 6 of the Austroads Guide to Road Design includes a new method to determine the risk associated with roadside crashes and to identify where risk mitigation treatments are required on urban and rural road networks. The approach establishes a Network Roadside Risk Threshold (NRRIT) which consistently directs the locations for treatments within projects. This webinar is focused on user guidance, including the practical application of the new method. The webinar describes the new procedure for evaluating a rural road network, how policies will influence decisions and how the NRRIT can consistently delineate road sections where treatments are required. The webinar also provides the basis of the procedure by using a simpler example so that participants can appreciate its broader application. The example demonstrates how risk graphs, based on contemporary knowledge, can be used to expedite the assessment procedure. Presented by Peter Ellis and Rod Troutbeck.

Fifteen years after it made landfall, Hurricane Katrina remains among the costliest Hurricanes in history. The major event also cast a renewed scrutiny on some old practices and ushered in a new generation of analysis for these catastrophic events. In this episode of “Transforming the Future of Risk: A Data-Centric Approach,” sponsored by RMS, Rosalie Donlon, editor-in-chief of ALM's insurance and tax publications, joins Robert Muir-Wood, Chief Research Officer at RMS, as they examine this evolving picture. Click play to hear the full episode.

Link to bioRxiv paper: http://biorxiv.org/cgi/content/short/2020.08.17.254276v1?rss=1 Authors: Booms, A., Pierce, S. E., Coetzee, G. A. Abstract: Genome-wide association studies (GWAS) have uncovered thousands of single nucleotide polymorphisms (SNPs) that are associated with Parkinsons disease (PD) risk. The functions of most of these SNPs, including the cell type they influence, and how they affect PD etiology remain largely unknown. To identify functional SNPs, we aligned PD risk SNPs within active regulatory regions of DNA in microglia, a cell type implicated in PD development. Out of 6,749 SNPs of interest from the most recent PD GWAS metanalysis, 73 were located in open regulatory chromatin as determined by both ATAC-seq and H3K27ac ChIP-seq. We highlight a subset of SNPs that are favorable candidates for further mechanistic studies. These SNPs are located in regulatory DNA at the SLC50A1, SNCA, BAG3, FBXL19, SETD1A, and NUCKS1 loci. A network analysis of the genes with risk SNPs in their promoters, implicated substance transport, involving autophagy and lysosomal genes. Our study provides a more focused set of risk SNPs and their associated risk genes as candidates for further follow-up studies, which will help identify mechanisms in microglia that increase the risk for PD. Copy rights belong to original authors. Visit the link for more info

This week, I sat down with my colleague, Dr. Richard Engler, Bergeson & Campbell’s Director of Chemistry, to discuss what the fuss is over EPA’s January 27, 2020, issuance of a “preliminary list” of companies responsible for the $1,350,000 per-chemical fee EPA charges to conduct a risk evaluation of a high-priority chemical under TSCA Section 6.  The scope of the entities “on the hook” is far broader than expected, and companies with little understanding of TSCA may be presumptively liable for these fees and TSCA enforcement scrutiny for failure to address the situation by March 27, 2020.  In our conversation, Rich explains how the fee rule works and discusses the reasons why industry was caught by surprise and unclear about how best to respond to the January notice.  Rich and I then explain why it is critically important for impact entities to begin now to think about forming a consortium to share the cost of the fees and related expenses and how B&C Consortia Management can assist. We also go into a number of different themes that might be of interest to you, including why the fee rule interpretation diverges from historical TSCA “carve-outs” for byproducts, impurities, and articles, and what companies can do to protect their interests. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

TSCA November 13, 2019 - Draft Risk Evaluation Scorecard by Keller and Heckman LLP

Andrew Penn, MS, NP, conducts a Masterclass lecture on psychedelic-assisted psychotherapy from the Psychopharmacology Update in Cincinnati. The meeting was sponsored by Global Academy for Medical Education and Current Psychiatry. Mr. Penn, a psychiatric nurse practitioner, is associate clinical professor of community health systems in the School of Nursing at the University of California, San Francisco. Later, Dr. Renee Kohanski is back – this time to discuss the need to call out the truth when we see it. *  *  * Help us make this podcast better! Please take this short listener survey: https://www.surveymonkey.com/r/podcastsurveyOct2019 *  *  * Reemergence of MDMA for PTSD and psilocybin for MDD Psychedelic-assisted psychotherapy is currently being investigated with 3,4-methylenedioxy-methamphetamine (MDMA) for treatment-resistant post-traumatic stress disorder (PTSD) and psilocybin for the treatment of major depressive disorder (MDD). The use of these compounds would be highly regulated. These are not medications that would be dispensed for a patient to take home. Both would be given in the clinical setting of one or more psychotherapy sessions with two therapists who would continue to work with the patient over time. MDMA was first patented by Merck in 1912, synthesized again in the 1970s, and used by psychotherapists to assist treatment. However, its recreational use spread, leading to its classification as a Schedule I controlled substance, thus prohibiting research or use in a medical setting. Lobbying through the Multidisciplinary Association for Psychedelic Studies, also known as MAPS, managed to bring MDMA into phase 3 clinical trials, and in 2017 the Food and Drug Administration granted breakthrough therapy designation for its use with psychotherapy for PTSD. MDMA is a potent releaser of serotonin, oxytocin, and prolactin, which in combination, allow the patient to feel less fear, trust the psychotherapist more, and overcome the defenses blocking them from talking about traumatic experiences. MDMA permits patients to stay in the optimal arousal zone to discuss the traumatic event. After the psychedelic-assisted session, patients continue to process memories and sequelae of the event and integrate changes into their lives to overcome trauma. If MDMA is approved by the FDA, it would be available only under a REMS, or Risk Evaluation and Mitigation Strategy, or  drug safety program. Psilocybin is a partial agonist on 5-HT2A serotonin receptors. The brain of a severely depressed person is extremely rigid with limitations on the usual predictive capacity of the human brain. Psilocybin facilitates plasticity to “reset” and see a situation as it truly is, rather than through the rigid cognitive distortions of depression. Although MDMA and psilocybin are controlled substances, we can think of these medications like anesthetics, which are drugs that can be prescribed in clinical settings under supervision only. These are old compounds used in a novel manner that can reduce suffering for patients who have not responded to the current modes of therapy for PTSD and MDD. References Mithoefer MC et al. MDMA-assisted psychotherapy for treatment of PTSD: Study design and rationale for phase 3 trials based on pooled analysis of six phase 3 randomized trials. Psychopharm (Berl). 2019 Sep;236(9):2735-45. Carhart-Harris RL et al. Psilocybin with psychological support for treatment-resistant depression: An open-label feasibility study. Lancet. 2016 Jul 1:3(7):619-21. Pollan M. The Trip Treatment. New Yorker. 2015 Feb 9. Cooper A. Psilocybin sessions: Psychedelics could help people with addiction and anxiety. 60 Minutes. 2019 Oct 13. Sessa B. “The Psychedelic Renaissance: Reassessing the Role of Psychedelic Drugs in 21st Century Psychiatry and Society.” London: Muswell Hill Press, 2012. Usona Institute: News on Psychedelics   For more MDedge Podcasts, go to mdedge.com/podcasts Email the show: podcasts@mdedge.com Interact with us on Twitter: @MDedgePsych  

Data is one of the greatest assets of a company, and when information is lost, it can result in substantial costs. Data can be lost several ways, the most common ways are through technology and process errors or external exposure. Firms such as Amazon and Walmart have had customer passwords leaked online, and these are only the significant breaches that we hear about, but there are many more. It also costs time and money to fix a breach. In a 2018 PwC UK report on the state of global information security, companies averaged a recovery time of 19 hours when they encounter a security breach, and 49 percent of these breaches occurred because of the lack of preparation. These figures should make it clear that securing corporate data is a must, and it is no longer just an option. As hackers and technology advance, companies and individuals need to stay ahead of the game. In this episode, we talk about assessing your risk and how you can minimize your exposure.

We begin this episode with a discussion of two recent clinical trials in lymphoma: CALGB 50303 and REMoDL-B, respectively published in the Journal of Clinical Oncology and The Lancet Oncology. We include a primer on the history of lymphoma and the development of R-CHOP. We follow that with an in-depth interview with Dr. Ameet Sarpatwari of the Harvard Medical School on Risk Evaluation and Mitigation Strategies (REMS), the Orphan Drug Act, and, broadly, the purpose of the US FDA. CALGB 50303: doi.org/10.1200/JCO.18.01994 REMoDL-B: doi.org/10.1016/S1470-2045(18)30935-5 Dr. Sarpatwari's online course: https://www.edx.org/course/the-fda-and-prescription-drugs-current-controversies-in-context Back us on Patreon! www.patreon.com/plenarysession

With Dr. Elaine Morrato, Associate Dean for Public Health Practice and Professor in Health Systems Management and Policy at the Colorado School of Public Health, and visiting scientist at FDA’s Office of Surveillance and Epidemiology Dr. Morrato joins RAPS senior editor Pam Jones for an insightful discussion on risk management, regulatory professionals’ role, REMS and its elements, and the translation of health innovation into practice. She also provides easily-accessible resources on the topic. Dr. Morrato has offered to answer any questions submitted on the topics discussed. To send questions for Dr. Morrato, please email RAPS at podcasts@raps.org

During this webinar we discussed: EPA’s First TSCA Draft Risk Evaluation – Pigment Violet 29 The Risk Evaluation Peer Review Process Participating in the Risk Evaluation Process

In this podcast episode, we will consider the rationale for using non-fasting labs to screen for ASCVD as well as review the controversies around their use and talk about the differential diagnosis of hypertriglyceridemia.

Guest: Cynthia Kear Guest: Tom McKeithen, Jr. Host: Alicia A. Sutton There is a national public health crisis concerning the misuse and overuse of opioid medications, and despite multiple large scale efforts to stem the tide, negative trends persist. In order to address risk and safety concerns, reduce serious adverse outcomes, and simultaneously ensure that pain patients maintain necessary access to opioids, the U. S. Food and Drug Administration (FDA) has developed a Risk Evaluation and Mitigation Strategy (REMS) that applies to all long-acting and extended-release opioid medications. Joining Alicia Sutton to discuss how REMS programs are being used to help inform and educate the medical community are Cynthia Kear and Tom McKeithen. Ms. Kear is Senior Vice President of the California Academy of Family Physicians, while Mr. McKeithen is Senior Consultant at Healthcare Performance Consulting

Integrating host and HBV characteristics, this study aimed to develop models for predicting long-term cirrhosis and hepatocellular carcinoma (HCC) risk in chronic hepatitis B virus (HBV) patients. This analysis included hepatitis B surface antigen (HBsAg)-seropositive and anti-HCV-seronegative participants from the Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer in HBV (R.E.V.E.A.L.-HBV) cohort. Newly developed cirrhosis and HCC were ascertained through regular follow-up ultrasonography, computerized linkage with national health databases, and medical chart reviews. Two-thirds of the participants were allocated for risk model derivation and another one-third for model validation. The risk prediction model included age, gender, HBV e antigen (HBeAg) serostatus, serum levels of HBV DNA, and alanine aminotransferase (ALT), quantitative serum HBsAg levels, and HBV genotypes. Additionally, the family history was included in the prediction model for HCC. Cox's proportional hazards regression coefficients for cirrhosis and HCC predictors were converted into risk scores. The areas under receiver operating curve (AUROCs) were used to evaluate the performance of risk models. Elder age, male, HBeAg, genotype C, and increasing levels of ALT, HBV DNA, and HBsAg were all significantly associated with an increased risk of cirrhosis and HCC. The risk scores estimated from the derivation set could accurately categorize participants with low, medium, and high cirrhosis and HCC risk in the validation set (P 

Overview of Risk Evaluation and Mitigation Systems (REMS)

Risk Evaluation and Mitigation Strategies: Assessment of a Medical Center’s Policies and Procedures Authors Lindsey Childs and Minh-Tri Duong discusses with William Zellmer, Contributing Editor for AJHP, the results of their institution’s initiative to improve compliance with federally mandated risk evaluation and mitigation strategies (REMS). The article under discussion appears in the May 15, 2012, issue of AJHP. For more information visit www.ajhp.org.

Risk Evaluation and Mitigation Strategies: Challenges and Opportunities for Health-System Pharmacists Author JoAnn Stubbings discusses with William Zellmer, Contributing Editor for AJHP, the structure of the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) program for medications and the challenges and opportunities that the program presents to health-system pharmacists. The article under discussion appears in the September 15, 2010, issue of AJHP. For more information visit www.ajhp.org.

Overview of Risk Evaluation and Mitigation Systems (REMS)