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Whelp, goodbye folks! Eric and I have been DOGE'd. In a somewhat delayed April Fools, Nancy Lundeberg and Annie Medina-Walpole have taken over podcast host duties this week. Their purpose is to interview me, Eric, and Ken Covinsky about your final AGS literature review plenary session taking place at the Annual Meeting in Chicago this May (for those attending, our session is the plenary the morning of May 10). We discuss our favorite articles, parody songs, and memories from AGS meetings past, with a little preview of a song for this year's meeting. We covered: The first parody song I wrote, for AGS 2018 in Orlando, about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Ken's favorite articles, including The Impact of Rudeness on Medical Team Performance: A Randomized Trial Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization Eric's favorite article on the effect of chair placement on physicians' behavior and patients' satisfaction Tim Anderson's study on the intensification of older adults' outpatient blood pressure treatment at hospital discharge Nancy's favorite topic and parody song, Aducanumab, which won Drug of the Year in 2021. Enjoy! And maybe, just maybe, Eric and I will be reinstated and return as hosts next week… -Alex Smith
Dr. Hoffman continues his conversation with investigative journalist Charles Piller, author of “Doctored: Fraud, Arrogance, and Tragedy in the Quest to Cure Alzheimer's Disease.”
Investigative journalist Charles Piller reveals deep-seated corruption in Alzheimer's research as chronicled in his book, “Doctored: Fraud, Arrogance, and Tragedy in the Quest to Cure Alzheimer's Disease.” The discussion delves into the issues surrounding Big Pharma's influence, fraudulent scientific studies, and the implications of a controversial 2006 experiment at the University of Minnesota. They also address the costly and marginally effective Alzheimer's drugs like Aducanumab, the challenges faced by alternative research hypotheses, and the significance of improving scientific integrity and checks and balances in medical research.
On this episode of Translating Proteomics, host Andreas Huhmer discusses advances in Alzheimer's research with special guest and Curie Bio Drug Maker in Residence, Sarah DeVos Ph.D. Their conversation focuses on:The impact of molecular diagnostics on Alzheimer's researchRecent Alzheimer's drug approvalsThe future of Alzheimer's research*Small edit on Sarah's background - She did her graduate work at Washington University in St. Louis and a Postdoc at Massachusetts General Hospital*Chapters00:00 – Introduction01:54 – Why Sarah began studying Alzheimer's03:39 – Current tools and needs for future Alzheimer's diagnostics09:52 – Recent drug approvals in the Alzheimer's space and their relationship to diagnostics14:26 – Is it possible to develop biomarkers that detect Alzheimer's at its earliest stages?16:36 – What is limiting the development of new Alzheimer's biomarkers?17:51 – The DIAN trials and learnings from studying dominantly inherited Alzheimer's19:33 – The genetics of Alzheimer's22:19 – Novel approaches to identifying and understanding Alzheimer's pathology 25:54 – Where can proteomics advance Alzheimer's research?31:25 – The role of proteomics in Alzheimer's animal models34:33 – Sarah's hopes for the next 10 years of Alzheimer's research41:39 - OutroResourcesDominant Inherited Alzheimer's Network (DIAN) trials research updateso In the DIAN trials, researchers work with families to study various clinical and basic science aspects of dominantly inherited Alzheimer's disease.Amyloid plaque reducing clinical trials:o Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer's Disease (Haeberlein et al. 2022)o Donanemab in Early Symptomatic Alzheimer Disease - The TRAILBLAZER-ALZ 2 Randomized Clinical Trial (Sims et al. 2023)o Lecanemab in Early Alzheimer's Disease (Van Duck et al. 2022)Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Car (Palmqvist et al. 2024)o Clinical research into a new phospo-tau biomarker that can help physicians more effectively diagnose Alzheimer's diseaseResurrecting the Mysteries of Big Tau (Fischer and Baas 2021)o Review covering a potentially neuro-protective form of tau called “Big tau”Integrated Proteomics to Understand the Role of Neuritin (NRN1) as a Mediator of Cognitive Resilience to Alzheimer's Disease (Hurst et al. 2023)o Paper linking the NRN1 protein to cognitive resilience in...
Discover the intricate ties between heart health and memory as we sit down with esteemed neurology expert Dr. Steven Toenjes and well-known cardiologist Dr. Michael Koren. They will give you insights that could reshape your understanding of Alzheimer's disease. The conversation transcends the traditional boundaries of amyloid PET scans and dissects the nuances of cognitive impairment. Through the compelling case scenario of Mr. Wrenchworth, they unveil the critical differences between normal age-related cognitive changes and genuine memory loss, illuminating the importance of comprehensive assessments in the face of memory concerns.Venture with us into the realm of vascular disease and its profound influence on cognitive function, where strokes and small vessel changes play an unexpectedly significant role. We navigate through the distinguishing features of dementia varieties, spotlighting how conditions like Lewy body and frontotemporal dementia present their unique challenges. Not only do we tackle the controversies surrounding Alzheimer's hypotheses, but we also examine cutting-edge interventions and the delicate balance between their benefits and potential risks, as seen in the Aducanumab and Lecanemab trials.Wrap up your journey with a deep dive into the emerging blood-based markers that promise to revolutionize the early detection of Alzheimer's. Dr. Toenjes and Dr. Koren scrutinize the pathological indicators of the disease and stress the imperative of modifiable risk factors, the restorative power of sleep, and the cognitive safeguarding properties of cardiovascular exercise. We conclude with a candid discussion on the controversial FDA approval of aducanumab and the essential, yet often overlooked, role of medication monitoring, particularly with treatments like Lecanemab. Join us for an episode that's not just a conversation but a gateway to understanding the future of Alzheimer's therapy.Take Home Talking Points:Understanding Alzheimer's Disease and Memory LossVascular Disease and Types of DementiaUnderstanding Alzheimer'sCardio and Music's Impact on Brain HealthTreatment for Cognitive DeclineAsymptomatic Brain Hemorrhages and Medication MonitoringRecording Date: January 26, 2024 a rebroadcast for the WJCT studio.Be a part of advancing science by participating in clinical researchShare with a friend. Rate, Review, and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow us on Social Media:FacebookInstagramTwitterLinkedInWant to learn more checkout our entire library of podcasts, videos, articles and presentations at www.MedEvidence.com Powered by ENCORE Research GroupMusic: Storyblocks - Corporate InspiredThank you for listening!
Host: Andrew Wilner, MD, FACP, FAAN Guest: Marc Haut, PhD A recent phase 1 study investigated the safety and feasibility of combining focused ultrasound and aducanumab, which is a monoclonal antibody for amyloid, to open the blood-brain barrier in patients with Alzheimer's disease. And what the researchers found was about a 50 percent overall reduction of cerebral amyloid-beta load in the target areas compared to the untreated areas. Dive further into these findings and next steps in this line of research that may impact the way we treat Alzheimer's disease with Dr. Andrew Wilner and Dr. Marc Haut, Director of the Rockefeller Neuroscience Institute's Memory Health Clinic at West Virginia University.
Episode 7 features an interview with Peter Whitehouse MD, PhD and Lon Schneider MD, MS exploring dementia and mild cognitive impairment. We chat about the medicalization of normal aging, the overdiagnosis of mild cognitive impairment, problems with new drugs and tests for Alzheimer's disease, and how to prevent dementia. Pharmanipulation is produced by PharmedOut, a project at Georgetown University Medical Center that advances evidence-based prescribing. Additional Resources PharmedOut resources on Alzheimer's and Mild Cognitive Impairment: https://sites.google.com/georgetown.edu/pharmedout/advocacy/alzheimers-and-mild-cognitive-impairment?authuser=0 Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Link: https://www.thelancet.com/article/S0140-6736(20)30367-6/fulltext Making the Case for Accelerated Withdrawal of Aducanumab. Link: https://content.iospress.com/articles/journal-of-alzheimers-disease/jad220262 Dr. Peter Whitehouse's latest letter to the editor, “Cummings column on Alzheimer treatments skips over a few key things.” Link: https://www.cleveland.com/letters/2023/10/cummings-column-on-alzheimer-treatments-skips-over-a-few-key-things.html American Dementia: Brain Health in an Unhealthy Society by Danny George PhD and Peter Whitehouse MD, PhD. Link: https://www.press.jhu.edu/books/title/12394/american-dementia The Myth of Alzheimer's: What You Aren't Being Told About Today's Most Dreaded Diagnosis by Peter Whitehouse MD, PhD and Danny George MSc. Link: https://us.macmillan.com/books/9780312368173/themythofalzheimers
What causes Alzheimer's? The main theory is that it's due to a build-up of amyloid plaques in the brain. But some scientists think that's hopelessly wrong, and that a hidebound belief in the amyloid hypothesis is stopping us from finding a cure.In this episode of The Studies Show, Tom and Stuart talk about the amyloid hypothesis of Alzheimer's, ask whether all the hype over the three recent Alzheimer's drugs (“a momentous breakthrough!”) is justified, and look at some ways we could do better research on dementia.The Studies Show is supported by the i, the UK's smartest daily newspaper. You can get a money-off deal on your digital subscription—which includes full access to all Stuart's science writing—by following this special podcast link.The Studies Show is brought to you by Works in Progress, the online magazine about science, technology, and human progress. If you're a listener to The Studies Show, it's a dead-cert that you'll love Works in Progress - and it's all available for free. Find the magazine at this link.Show notes* The Mini-Mental State Examination (MMSE) - the test Stuart quotes at the start* NHS list of Alzheimer's symptoms* List and discussion of possible theories for the cause of Alzheimer's* Chris Hemsworth interview about finding out he's at high genetic risk of Alzheimer's* Potential clues about the origin of Alzheimer's from Down Syndrome* Sharon Begley's STAT article on “how an Alzheimer's ‘cabal' thwarted progress toward a cure for decades”* Science investigation of potential fraud in the original Aβ*56 study* Explanation of why it's bad, but not devastating for the amyloid hypothesis* Independent panel urges the FDA not to approve Aducanumab - but they do so anyway* Derek Lowe's highly sceptical discussion of the “disgraceful” approval* Stuart's sceptical article in the i on Lecanemab (link to the trial itself)* BBC article on the “momentous breakthrough”* “16 cautionary notes” on Lecanemab* Stuart's sceptical article in the i on Donanemab (link to the trial itself)* And Stuart's Twitter thread on “clinically meaningful” effects in Alzheimer's* BBC More or Less episode discussing the problems with measuring the effect of an Alzheimer's drug* How do the new Alzheimer's drugs work in theory? One potential explanation* Paper by Elliot Tucker-Drob on how we measure dementia and how we forget about individual differences while doing soCreditsThe Studies Show is produced by Julian Mayers at Yada Yada Productions. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.thestudiesshowpod.com/subscribe
I discuss the safety and efficacy of the newest Alzheimer's drug treatments, aducanumab (Aduhelm) and lecanemab (Leqembi).
Dr. Heather Sandison discusses How to Reverse Alzheimer's Disease with Dr. Ben Weitz. [If you enjoy this podcast, please give us a rating and review on Apple Podcasts, so more people will find The Rational Wellness Podcast. Also check out the video version on my WeitzChiro YouTube page.] Podcast Highlights 3:05 The most recent drugs for Alzheimer's disease that have recently been approved, including Aducanumab, that remove beta amyloid from the brain, do not actually make patients better and may make them worse. I did a podcast with Dr. Bredesen in episode 271 where we discussed that the landmark study that supposedly showed that the amyloid plaque that was seen in the brains of Alzheimer's patients in the landmark paper in Nature in 2006 that was so influential in influencing this whole amyloid hypothesis of Alzheimer's disease, that these images were falsified. Dr. Sandison said that she wishes for all the patients and the families of those out there who are suffering with a loved one who has dementia that there was a pill or an IV that would just make the nightmare go away. Unfortunately, despite the billions of dollars that have been spent on this problem and despite the uncountable hours of really smart researchers who have been working on the concept, they have been barking up the wrong tree. The two most recent drugs approved are Aducanumab and Lecanemab they both cause brain swelling and brain bleeding and at most they make you get worse at a slower rate. They might keep your mom in memory care longer. But your goal should be to have your mom improve and get out of memory care. 7:02 The great news is that we have an alternative, which is the precision medicine/Functional Medicine approach pioneered by Dr. Dale Bredesen. Dr. Sandison is working on a book called Reversing Alzheimer's that will be published in June 2024 by Harper and she has just published a paper using this Functional Medicine model in the Journal of Alzheimer's Disease: Sandison H, Callan NGL, Rao RV, Phipps J, Bradley R. Observed Improvement in Cognition During a Personalized Lifestyle Intervention in People with Cognitive Decline. J Alzheimers Dis. 2023 Jun 19. This paper is similar to the one that Dr. Bredesen and Dr. Kat Toups published in the Journal of Alzheimer's in July 2022, but Sandison's trial used patients who had more severe cognitive decline and she got similar results. Toups K, Hathaway A, Gordon D, Chung H, Raji C, Boyd A, Hill BD, Hausman-Cohen S, Attarha M, Chwa WJ, Jarrett M, Bredesen DE. Precision Medicine Approach to Alzheimer's Disease: Successful Pilot Project. J Alzheimers Dis. 2022;88(4):1411-1421. Bredesen used patients who had a MoCA (Montreal Cognitive Assessment) score of 19 or better, while Sandison took participants with a MoCA scores between 12 and 23. This showed that this Functional Medicine approach can work with patients with more severe cognitive decline. While the Bredesen study lasted nine months, the Sandison study only lasted six months. They were both pilot studies with 23-25 patients. The Sandison study saw 73.9% of our participants improve their cognitive function, while the Bredesen study saw 84% improvement of cognitive function. The key thing to focus on is that this Functional Medicine approach did not just slow the decline of cognitive function as these super expensive drugs did, but patients actually got better and had improved cognitive function! 11:33 While we might not yet be seeing a significant change in attitudes among conventional doctors or among insurance companies, who essentially control the healthcare system in the US, the Journal of Alzheimer's Disease is highlighting Dr. Sandison's paper in their annual periodical. And things will have to change because there are a massive number of people in the baby boomer generation who are approaching the age at which the risk is higher and there might be so many with Alzheimer's that the cost of caring for the...
We've talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA's decision to approve it. But wait, there's a shiny new anti-amyloid drug, lecanemab! (No it's not just the French version of Aducanumab). In an article in the NEJM (a published article this time, wonder of wonders!) lecanemab was shown to slow the rate of cognitive decline by 0.45 points on an 18 point cognitive scale compared to placebo. Wow! Wow? Wait, what? On today's podcast we talk with Jason Karlawish, who we've had on previously talking about his book The Problem of Alzheimer's and with Aaron Kesselhim, to discuss FDA approval of Aducanumab, as well as frequent guest and host Ken Covinsky. They debate today's central question: is it time for geriatricians to get on board with lecanemab? Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? What about the burdens, risks, and harms? Every 2 week visits for infusions, regular monitoring for brain swelling and bleeding, case report level risk of death? Did the study do enough to address issues of inclusion and diversity by age, race and ethnicity, and multimorbidity? What does this study say about the amyloid hypothesis? Should the FDA approve, and under what conditions? Their answers may surprise you. As a preview of final thoughts at the end of the episode, Ken and Jason agree that the FDA should approve lecanemab conditional on a post-approval monitoring system and public access to study data, geriatricians should be prepared to have thoughtful conversations with patients about the risks and benefits of lecanemab in view of their values and priorities, and ultimately, that geriatricians should be open to prescribing it. Wow! The times, they are a changin. -@AlexSmithMD
Aducanumab (brand name Aduhelm) drew headlines when it was approved by the FDA in 2021 against the recommendations of the FDA advisory committee. Today it's almost commercially dead. On this episode are joined by P4 student Ise Brockmann to dive into aducanumab's story. email: econrxpodcast@gmail.com Twitter/Instagram: @EconRx LinkedIn: www.linkedin.com/company/econrx Website: https://econrx.libsyn.com/
Dr. Mandy Leonard, Senior Director of Drug Use Policy and Formulary Management at Cleveland Clinic and Steven Lucio, Senior Principal in Pharmacy Solutions at Vizient discuss their insights on the approval, role, and coverage of Aducanumab, the first drug in a new class approved for Alzheimer's by the FDA's accelerated approval process. Guest speakers: Mandy Leonard, PharmD, BCPS Senior Director of Drug Use Policy and Formulary Management Cleveland Clinic Steven Lucio, PharmD, BCPS Senior Principal in Pharmacy Solutions Vizient Moderator: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence Show Notes: [00:47 -3:06] Other factors driving aducanumab formulary decision making [03:07-6:35] How CMS is managing this medication [06:36-9:04] What should patients and families know about this medication? [09:05-12:33] What frontline pharmacists should know about this medication Links | Resources: To use Aduhelm or not to use Aduhelm- that is the question…now what is the evidence? Part 1 EMERGE and ENGAGE American Academy of Neurology statement Subscribe Today! Apple Podcasts Amazon Podcasts Google Podcasts Spotify Stitcher Android RSS Feed
Dr. Mandy Leonard, Senior Director of Drug Use Policy and Formulary Management at Cleveland Clinic and Steven Lucio, Senior Principal in Pharmacy Solutions at Vizient discuss their insights on the approval, role, and coverage of Aducanumab, the first drug in a new class approved for Alzheimer's by the FDA's accelerated approval process. Guest speakers: Mandy Leonard, PharmD, BCPS Senior Director of Drug Use Policy and Formulary Management Cleveland Clinic Steven Lucio, PharmD, BCPS Senior Principal in Pharmacy Solutions Vizient Moderator: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence Show Notes: [01:20 -4:16] How aducanumab fits into the treatment of Alzheimer's disease [04:17-8:29] Accelerated Approval process and Aducanumab [08:30-14:38] Aducanumab trials and efficacy [14:39-17:24] Aducanumab trials and safety Links | Resources: EMERGE and ENGAGE Subscribe Today! Apple Podcasts Amazon Podcasts Google Podcasts Spotify Stitcher Android RSS Feed
KSQD 8-06-2022: Opinion piece about the decline in childhood vaccinations; Good nutrition, exercise and stress reduction can alter progress of prostate cancer -- the role of the microbiome; The expensive Alzheimer's drug, Aducanumab, is reviewed one year later
Dr. Ebell and Dr. Wilkes discuss the POEM titled ' Aducanumab is not effective for mild cognitive impairment or mild Alzheimer's dementia and has major safety issues '
John has the week off, so Kate, Mark and Henry plow forward rudderless and talk about monkeypox (sorry, WHO, we're not calling it hMKPX, buy a vowel), screening for atrial fibrillation, and our new candidate for worst drug ever: aducanumab for Alzheimer dementia.
Author Sara Manning Peskin's “A Molecule Away from Madness: Tales of the Hijacked Brain” is a harrowing examination of the human brain, its mysteries, and its potential for disruption. She joins us on the Behavioral Corner with the story of what we know and are learning in neuroscience.-------------------------------The Behavioral Corner Podcast is made possible by Retreat Behavioral Health. Learn more - https://www.retreatbehavioralhealth.com.
Welcome to the NeurologyLive® Mind Moments™ podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, we mark 1 year since the FDA granted accelerated approval to aducanumab (Aduhelm; Biogen), the first approval in Alzheimer disease since 2003. This episode offers an abridged recap of the events that have taken place over the course of its clinical journey, and in the year since that decision. Later this month, the June 2022 issue of NeuologyLive® will include a cover story that features a more in-depth and extensive review of the aducanumab saga and its implications for the clinical community from David S. Knopman, MD, a portion of which is featured in this episode. The June 2022 issue, including Dr. Knopman's story, can be viewed here: www.neurologylive.com/journals/neurologylive Thanks for listening to the NeurologyLive® Mind Moments™ podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com. This episode featured the songs "Dreams" and "Stronger" by Alan Špiljak, obtained under the CC BY-NC-ND 4.0 license.
The June 2022 replay of past episodes showcases a selection of interviews about the impact of the FDA's approval of aducanumab for the treatment of Alzheimer disease (AD). This episode features illuminating conversations with Drs. Gregg Day, Ron Petersen, and Jason Karlawish on the clinical science guiding amyloid-based treatments for AD, the importance of patient participation when considering the use of aducanumab, and the business of Alzheimer disease, respectively. This month's Recall concludes with an interview featuring Pulitzer Prize-winning journalist Pam Belluck on Medicare's limitations on aducanumab coverage.
It's been nearly a year since the introduction of the breakthrough drug Aducanumab. Dr. Monica gives us an update and discusses some new treatments on the horizon.
Joseph C. Osborne II, PharmD, @JOzempic describes the pharmacology of aducanumab, summarizes the clinical literature and approval process for aducanumab, and discusses stewardship considerations of aducanumab. Twitter: @JOzempic For more pharmacy content, follow Mayo Clinic Pharmacy Residency Programs @MayoPharmRes or the host, Garrett E. Schramm, Pharm.D., @garrett_schramm on Twitter! You can also connect with the Mayo Clinic's School of Continuous Professional Development online at https://ce.mayo.edu/ or on Twitter @MayoMedEd.
What's all the hullabaloos about Aduhelm, the first new Alzheimer's drug approval since 2003? This month's MedEvidence guest, Dr. Steven Toenjes, MD, a board-certified neurologist, former staff neurologist in the U.S. Navy and an award-winning director of neurology residents at the Uniformed Services University of Health Sciences and decorated Navy veteran joins Dr. Michael Koren and Michelle McCormick to discuss the first new Alzheimer's drug approval since 2003 and the controversy over FDA's approval of Biogen's Aducanumab (Aduhelm). Updated information on Medicare's decision to cover Alzheimer's drugsSubscribe to MedEvidence! Podcast to be notified each Wednesday as new episodes are released.Free Memory ScreeningBe a part of advancing science by participating in researchFollow MedEvidence! on Social Media to discover the Truth Behind the Data.FacebookInstagramTwitterLinkedInPowered by ENCORE Research Group at www.ENCOREDOCS.comOriginal Air Date: March 11, 2022
What are the consequences of the COVID-19 pandemic for Black Americans? Find out about this and more in today's PV Roundup podcast.
Show references: https://www.alzforum.org/news/research-news/aduhelm-phase-3-data-aria-common-sometimes-serious
With the controversial approval of Alzheimer's drug Aducanumab in the United States, we speak to neurologist and medicinal chemist Dr. Donald Weaver, to break down the science, sift through the hype, and help us understand why it's so difficult to diagnose and treat a disease that affects more than 55 million people worldwide. As the co-Director of Krembil Brain Institute and with thirty years of experience as both a doctor and a scientist, Dr. Weaver is not convinced this new drug is the answer. But he says progress is being made and there's plenty of reason for hope. Plus, we go on an inspiring journey with Patty Kim, who is caring for her mother with Alzheimer's and there are tangible tips on how to reduce your chances of getting Alzheimer's or dementia.Featuring: Dr. Weaver, Neurologist, Medicinal Chemist, and the co-Director of KBISpecial thanks to Patty Kim for sharing her story.To hear more from Patty, listen to her full story here: https://www.uhn.ca/Krembil/Complex-Brain-Podcast/Additional Resources:Krembil Brain Institute Dr. Donald Weaver's lab websiteThe Alzheimer Society of CanadaOntario Caregiver Organization Toronto Rehabilitation Institute's Specialized Dementia Unit Toronto Dementia Research AllianceVideos:Risk Factors for Alzheimer's and DementiaLiving with Dementia: A Caregiver's PerspectiveThe Future of Alzheimer's Symposium
Welcome back to the Season 2 premiere of Neurotech Pub!In this episode, host and Paradromics CEO Matt Angle sits down with fellow Founder/CEOs Carolina Aguilar, Brian Pepin, and Kunal Ghosh to talk shop about building cutting edge neurotech companies from the ground up. We dive deep into business strategies, the neurotech fundraising landscape, emerging therapeutics, and more. We also provide an insider's view of the intersections of data, pharma, and med devices that are shaping the future of healthcare. Pour yourself a cold one and settle in! Check out full video with transcript here: Check out video and a full episode transcript here. 00:00 | Updates & News >> INBRAIN Neuroelectronics raised a $17M Series A >> Rune Labs raised a $22.8 Million Series A >> Inscopix Launched Cloud-Based Platform for Data Management and Analysis2:15 | Meet the panel and pick up a book1:54 | Jester King Brewery 2:25 | Rune Labs 2:50 | Neurostimulator for deep brain stimulation therapy 3:23 | INBRAIN Neuroelectronics 4:11 | Inscopix 5:24 | Ursula K. Le Guin's 'The Dispossessed' 6:19 | Yuval Noah Harari's 'Sapiens: A Brief History of Humankind' 6:32 | Daniel G. Miller's 'The Tree of Knowledge' 6:40 | Jiddu Krishnamurti's 'The Book of Life' 7:34 | Barack Obama's 'A Promised Land,' ‘Dreams from my Father,' & ‘The Audacity of Hope' 7:56 | Karl Popper's 'The Open Society and Its Enemies'9:25 | Venture Capital in Neurotech34:44 | Business Strategy in Neurotech40:32 | Tom Oxley, CEO, Synchron 43:58 | Dr. Thomas Insel 44:06 | Mindstrong Mental Health Care 44:35 | Aduhelm controversy 52:25 | Galvani Bio 59:39 | Percept Neurostimulator 1:00:32 | Neuromodulation and the future of treating brain disease 1:07:21 | Software as a Medical Device FDA Guidance1:09:12 | State of Animal Model Systems1:14:28 | α-Synuclein in Parkinson's Disease 1:18:01 | Alto Neuroscience 1:18:36 | Flatiron Foundation 1:18:45 | Gaurdent Health 1:19:03 | Melanoma Trends & Rates1:21:41 | The Pharma-Data-Device Ecosystem 1:21:42 | Frank Fischer, Chairman of Neuropace 1:22:28 | Neurotech Pub Season 1, Episode 9 1:26:35 | Roche acquisition of Flatiron Health & merger with Foundation Medicine 1:27:12 | Companion Diagnostics 1:28:29 | Adhulem and PET imaging 1:29:09 | Resignations at the FDA over Alzheimer's Drug 1:29:32 | Derek Lowe's take on the Aducanumab Approval, FDA Committee Votes, Halting the Aducanumab Trials, & The FDA Advisory Committee Briefing Document on Aducanumab 1:31:39 | Donanemab receives breakthrough therapy designation in 2021 1:36:58 | Mapping the Frontal-Vagal Pathway 1:37:09 | The Human Connectome Project 1:40:07 | Teal Organizations and Holacracy 1:41:18 | Society for Neuroscience 1:44:37 | Affymetrix (Thermo Fisher Scientific) 1:44:39 | IlluminaWant more?Follow Paradromics & Neurotech Pub on Twitter Follow Matt, Brian, Carolina, & Kunal on Twitter
Der Klinisch Relevant Podcast liefert Ärztinnen und Ärzten sowie Angehörigen der Pflegeberufe und medizinischer Fachberufe wie Physiotherapie, Ergotherapie und Logopädie kostenlose und unabhängige medizinische Fortbildungsinhalte, die Du jederzeit und überall anhören kannst.
New and effective therapies are sorely needed for the treatment of Alzheimer's Dementia. When the FDA approved the first new drug for Alzheimer's Dementia in 18 years though, it was met with unprecedented criticism from experts in the fields of neurology and gerontology. So, what's the deal with aducanumab? Join us and panelists Ashley Campbell, Pharm.D., BCPS and Shannon Rice, Pharm.D., BCGP, as we discuss the data behind aducanumab's efficacy, safety, and whether or not this medication should be used as a standard in clinical practice. Follow-up points from this podcast: Citation on the minimum clinically important difference in the Clinical Dementia Rating Scale – Sum of Boxes: Andrews JS, Desai U, Kirson NY, Zichlin ML, Ball DE, Matthews BR. Disease severity and minimal clinically important differences in clinical outcome assessments for Alzheimer's disease clinical trials. Alzheimers Dement (N Y). 2019;5(1):354-363. The MRI monitoring frequency implemented in the ENGAGE and EMERGE Trials was at baseline, 3 months, 5 months, 7 months, and then every 3 months thereafter until study completion. Interested in joining the Orange County Society of Health-System Pharmacists? Join us at https://ocshp.com/join-us/ ! Interested in appearing on the podcast? Let us know by emailing leadership@ocshp.com.
In this episode we continue our discussion of the implications of the approval of the Alzheimer's drug Aduhelm (generic name Aducanumab). Our guest this week is Professor Nicholas Bagley. Bagley is a professor of law at the University of Michigan Law School and a contributing writer to the Atlantic. Recently he wrote an article titled “The Drug that Could Break American Health Care” that discusses some of the broader (unintended) consequences of the approval of Aducanumab. In this episode we discuss some of the broader cost implications of the new drug. PRODUCER'S NOTE: Since the recording of this interview, Medicare officials have announced the largest ever dollar-amount rate hike for Part B coverage citing the need to build contingency reserves to potentially cover the Alzheimer's drug, Aduhelm. Professor Bagley discusses the concern of the cost of Aduhelm to the US Healthcare System in this Minding Memory episode. The transcript for this episode can be found here. Related Links: CAPRA Website: http://capra.med.umich.edu/ Atlantic Article – The Drug that Could Break American Healthcare by Nicholas Bagley & Rachel Sachs: https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/ You can subscribe to Minding Memory on Apple Podcasts, Spotify, Google Podcasts or wherever you listen to podcasts. Hosted on Acast. See acast.com/privacy for more information.
Aducanumab is a new drug designed to remove amyloid in the brain. Following an accelerated process, the Food and Drug Administration approved Aducanumab as a treatment for Alzheimer's disease despite (what many experts feel) little evidence of effectiveness. In this episode we discuss the approval of Aducanumab with Dr. Jason Karlawish from the University of Pennsylvania and talk about what it could mean for drug discovery going forward. The transcript for this episode can be found here. Related Links: CAPRA Website: http://capra.med.umich.edu/ The Problem of Alzheimer's by Jason Karlawish: https://us.macmillan.com/books/9781250218742 Jason Karlawish Website: jasonkarlawish.com FDA Aducanumab Approval Press Release (June 2021): https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug You can subscribe to Minding Memory on Apple Podcasts, Spotify, Google Podcasts or wherever you listen to podcasts. Hosted on Acast. See acast.com/privacy for more information.
This week, Peter Simons covers a study that found prolactin-increasing antipsychotics associated with increased breast cancer risk, an analysis that found no convincing evidence that screening for depression improves outcomes, and the continuing controversy around the FDA's approval of Biogen's failed Alzheimer's drug aducanumab. Antipsychotics Linked to Increased Breast Cancer Risk Screening for Depression in Primary Care Does Not Improve Outcomes Alzheimer's Drug Controversy Continues
The FDA label for the amyloid antibody aducanumab (Aduhelm) started off exceedingly broad, basically including anyone with Alzheimer's disease, but was subsequently narrowed to to patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer disease (AD). Should, though, the label be even more restrictive to mirror the populations studied in the two still unpublished trials of the drug, EMERGE and ENGAGE? Or should CMS consider restricting coverage for aducanumab to populations meeting trial eligibility criteria and requiring additional evidence on clinical outcomes in groups excluded from the trials? In today's podcast, we talk with Tim Anderson and Marco Canevelli, the authors of two recent articles published about the real world eligibility of aducanumab: Tim Anderson was first author of a JAMA research letter that found that more than 92% of Medicare beneficiaries with Alzheimer's Dementia and 85% of those with MCI would have been excluded in the clinical trials of aducanumab based on their age or comorbid conditions. Marco was first author of a JAGS letter to the editor that systematically applied the EMERGE and ENGAGE exclusions to 911 patients with cognitive complaints who went to A geriatric outpatient unit in Milan (Italy). Only six patients (i.e., 0.66%) of these patients would potentially be candidates to aducanumab. For more podcasts on aducanumab, check out these two: All things Amyloid, including Aducanumab and Amyloid PET scans with Gil Rabinovici Aducanumab (Aduhelm) for the Treatment of Alzheimers: A Podcast with Aaron Kesselheim and Jason Karlawish
In this episode, I had the honor of speaking with Dr. Nathaniel Chin about Aducanumab/Aduhelm the new FDA approved Alzheimer's drug. Dr. Chin is an assistant professor in the division of geriatrics and gerontology. Dr. Chin received his undergraduate and medical degrees from the University of Wisconsin-Madison. He then went to the University of California-San Diego for his internal medicine residency. After completing his residency he spent the next two years working as a Hospitalist for Kaiser Permanente before returning to WI in 2015 to help his mother provide care for his father who had been diagnosed with Alzheimer's disease. He completed his geriatric fellowship in 2016 and spent another year in a dementia research fellowship within geriatrics. He was then hired as an assistant professor. Dr. Chin sees patients in the UW Health Memory Clinic and in addition to providing diagnoses he focuses on palliative care in chronic disease management. In addition to his clinical and research work, he is the medical director of the WI Alzheimer's Disease Research Study and the Wisconsin Registry for Alzheimer's Prevention Study, the Co-Leader of the ADRC Clinical Core, as well as the Associate Director of the Geriatric Memory Clinics at UW-Health. He also serves on the board of the WI Alzheimer's Association and the Alzheimer's Foundation of America. Dr. Chin is a Co-Investigator on 5 NIH grants, with one of them focused biomarker disclosure. He presents frequently on the topics of AD and geriatrics and in the past 3 years has given over 55 presentations at local, regional and national conferences. He has created over 100 podcasts on AD research and caregiving topics under his podcast called Dementia Matters. Please tune in for a great learning session on this new drug and more.
On June 7th, 2021 FDA approved the amyloid beta-directed antibody aducanumab (Aduhelm) for the Treatment of Alzheimers. This approval of aducanumab was not without controversy. Actually, let me restate that. The approval of aducanumab was a hot mess, inside a dumpster fire, inside a train wreck. After the approval, three members of the FDA advisory panel, which unanimously was not in favor of the approval of aduhelm, quit. One of them, Aaron Kesselheim (who we have on our podcast today) described it as “the worst drug approval decision in recent U.S. history" in his resignation letter. Then the FDA had to revise the label one month after publishing it because the original didn't even come close to looking like the population in which treatment was initiated in clinical trials. Then, wait for it, after a firestorm of criticism the FDA's commissioner had to ask for an independent investigation to look into the interactions between Biogen representatives and FDA members. And now CMS is deciding if and how to cover Aduhelm, a drug that will cost at least $56,000 a year per patient not incluiding the doctor's visits, amyloid PET scans, and frequent MRIs that will be necessary to monitor for side effects. On today's podcast we talk all about aducanumab with Aaron Kesselheim, Professor of Medicine at Harvard Medical School and previous member of that now famous FDA advisory committee, as well as Jason Karlawish, Professor of medicine, medical ethics and health policy, and neurology at the University of Pennsylvania Perelman School of Medicine. I'd love to point you to the journal articles for the two phase III trials on aducanumab, but as of yet, they are unpublished (this should tell you a little about the faith Biogen has on its drug data), so I'll leave you with these resources instead: Our podcast with Gil Rabinovici on “All things Amyloid, including Aducanumab and Amyloid PET scans” AGS's preliminary advice on prescribing Aducanumab - Jason Karlawish's book, The Problem of Alzheimer's, and the previous podcast that we did on it FDA's document dump on Aduhelm Biogen's open letter to the Alzheimer's disease community complaining about the “turn outside the boundaries of legitimate scientific deliberation” that has occurred with aduhelm (while ignoring the fact that the trials have not been published yet). CMS's request for public comment for their National Coverage Determination analysis to determine whether Medicare should cover the drug and any other monoclonal antibodies directed at amyloid The last one is particularly important as whether you are for or against the coverage of aducanumab, your voice matters. There is a letter being circulated by physicians who care for people with Alzheimer's Disease urging CMS not to cover aducanumab given the limited clinical evidence for benefit, known harms, and exorbitant cost. You can find the letter here. If you would like to sign the letter, you can add your name by clicking this link.
This week, Peter Simons provides an update on the FDA's controversial approval of Alzheimer's drug aducanumab, a new guideline for psychoeducation about ADHD, a study linking poverty rates and youth suicide, and an article providing essential information about antidepressant withdrawal. Federal Investigation into FDA Approval of Alzheimer's Drug Guideline for Education about ADHD Poverty Rates in US Counties Predict Youth Suicide Risk Four Essential Studies on Antidepressant Withdrawal Every Prescriber Must Read
What's the Word: Osculant; News Items: FDA Approval of Aducanumab, New Kind of Supernova, Icelandia, Shorter Work Week; Your Questions and E-mails: Faith vs Belief; Name That Logical Fallacy; Science or Fiction
Modern Healthcare Hospital Operations Reporter Alex Kacik and Insurance Reporter Nona Tepper discuss why more Americans are bypassing their insurance coverage at the prescription counter. Related story links: -High cost, high deductibles inspire cash pay -Adulhelm raises questions about financial conflicts among patient groups Subscribe to Modern Healthcare Follow us on Twitter: -Modern Healthcare (@modrnhealthcr) -Alex Kacik (@alex_kacik) -Nona Tepper (@ntepper90) Music Credit: Coffee by Cambo
On June 7th, the U.S. Food and Drug Administration approved aducanumab, the first new Alzheimer's treatment since 2003. Aducanumab is a monoclonal antibody that has been shown to reduce the build up of a protein known as beta amyloid that some think might be one of the possible causes of Alzheimer's disease. While the approval has been applauded by some, it is not without controversy. We will be asking our guests how innovation in the search for treatments of Alzheimer's disease is evolving.Our guest speakers are Mei Mei Hu, Chief Executive Officer at Vaxxinity, Hans J. Moebius, Chief Medical Officer at Athira Pharma, Raymond J Tesi, Chief Executive Officer and Chief Medical Officer at Inmune Bio, as well as Jerre Stead, Executive Chairman and Chief Executive Officer of Clarivate Plc, and Jonathan Searles, Senior Director on the CNS/Ophthalmology therapy team at Clarivate. See acast.com/privacy for privacy and opt-out information.
This week we talk about smallpox, the FDA, and Aducanumab.We also discuss Biogen, regulatory capture, and the Food, Drug, and Cosmetic Act. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit letsknowthings.substack.com/subscribe
It's been nearly two decades since there has been an approved drug for the treatment of Alzheimer's disease. In an exciting development, Biogen's drug aducanumab (Aduhelm) received conditional approval from the US Food and Drug Administration. Dr. Alireza Atri, director at Banner Sun Health Research Institute and leader in clinical research for the past 20 years, joins the conversation to help us untangle the renewed hope in the field and the complexities surrounding this decision. Dr. Atri acknowledges that this is an important step forward in our fight to end Alzheimer's before losing another generation, but it's one step in a complex process ahead. Hear him discuss what steps care partners and those with the disease should take with their physician, and just how soon this treatment may be available to qualified candidates. Disclosures Dr. Atri disclosed relevant relationships with Biogen.
This week is a special two-part episode focusing on last week's controversial — some say inflammatory — decision to approve aducanumab, a new Alzheimer's drug. In these episodes, I talk with two Alzheimer's experts with vastly different viewpoints on the news. First up: Dennis J. Selkoe, a physician and scientist whose research is at the core of how Aduhelm works.
This week is a special two-part episode focusing on last week's controversial — some say inflammatory — decision to approve aducanumab, a new Alzheimer's drug. In these episodes, I talk with two Alzheimer's experts with vastly different viewpoints on the news. Second up: Jason Karlawish, an Alzheimer's physician who wrote a First Opinion in May about how he would not prescribe the drug, were it to be approved.
This week, Peter Simons covers the latest news on the FDA's approval of failed Alzheimer's drug aducanumab, against the recommendation of its own advisory committee, which led to three members of the committee resigning in protest. He also covers an article confirming yet again that the FDA's black box warning that antidepressants can cause suicide did not increase suicides. Finally, he covers a study that reveals what exactly service users value about hearing voices groups, and why they are so important. FDA Approves Failed Drug Against Advisory Committee Recommendation No, the FDA's Black Box Warning Did Not Increase Suicides Qualitative Study Highlights the Meaning and Impact of Hearing Voices Groups
Here are the links for everything discussed in Episode 63. Times are also below so feel free to skip around and get to the drugs that interest you. (1:18) New treatment for weight management - Wegovy (6:38) Lybalvi approved for schizophrenia and bipolar 1 (9:43) Controversial treatment for Alzheimers approved - Aduhelm CDC updates on COVID-19 & influenza reporting Connect with The Rx Daily Dose:Twitter Instagram YouTube Linkedin WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter Instagram Linkedin ★ Support this podcast on Patreon ★
Join Health Affairs Insider.This week, the US Food and Drug Administration approved Aduhelm (aducanumab) to treat patients with Alzheimer's disease using an accelerated approval pathway.The drug was approved on June 7, 2021, and the decision was quick to spark controversy. At least two members of a panel of outside advisors to the FDA from Mayo Clinic and Washington University resigned in protest over the drug's approval.Clinical trials for the drug, which is manufactured by Biogen, showed a reduction in amyloid beta plaques. According to the FDA, that is "a hallmark finding in the brain of patients with Alzheimer's" and "is expected to lead to a reduction in the clinical decline of this...form of dementia."But there remain concerns about the drug's side effects in addition to its price tag.Health Affairs' Senior Editor Leslie Erdelack joins Deputy Editor for Special Content Rob Lott on this episode of Health Affairs This Week to discuss the approval and review outstanding questions, drug pricing, and whether pharmaceutical companies might look to old data for new drug approvals. Related Links: The FDA's Approval of Aduhelm: Potential Implications Across A Wide Range Of Health Policy Issues and Stakeholders (Health Affairs Blog) Limiting Coverage Based On Efficacy And Safety: A Path For Medicare Regarding The Alzheimer's Treatment Aducanumab (Health Affairs Blog) The Search For Effective Alzheimer's Therapies: A Work In Progress (Health Affairs) Subscribe: RSS | Apple Podcasts | Spotify | Castro | Stitcher | Deezer | Overcast
FirstWord Pharma PLUS editors Becky Simon, Michael Flanagan and Simon King discuss FDA approval of the first potentially disease modifying Alzheimer's disease treatment Aduhelm (aducanumab), which has dominated industry headlines this week. Simon also speaks to EQRx President and Chief Operating Office Melanie Nallicheri about the company's aspirations to disrupt pharmaceutical pricing and what describes as its “data coming out part” at ASCO this past weekend.
Aducanumab the controversial new drug for Alzheimer's disease, just approved by the FDA in the US is the first approved breakthrough in nearly 20 years. But, as Sarah Boseley explains, scientists dispute the drug's effectiveness. Good news from a study published in Lancet Healthy Longevity looking at protection levels from getting Covid. It studied the risk of COVID reinfection in care home staff and occupants up to 10 months after first being unwell and showed substantial levels of protection is retained. And a new paper on Vitamin D deficiency in Africa – the first large prevalence study in children on the continent. Plus bestselling author and gynaecologist Dr Jen Gunter on her Menopause Manifesto, part two in our mini-series on Health Check. Dr Gunter unpicks the facts and feminism of how society's focus on what happens to women's bodies has shaped and hindered treatment for the menopause. Presenter: Claudia Hammond Producer: Erika Wright Image: Abstract medical icon of head showing Alzheimer's memory loss due to dementia and brain disease Credit: wildpixel/Getty Images
There are no currently approved disease modifying drugs for Alzheimer's disease, but in a couple months that may change. In July of 2021, the FDA will consider approval of a human monoclonal antibody called Aducanumab for the treatment of Alzheimer's disease. If approved, it will not only make this drug the defacto standard of care for Alzheimer's disease, but will create a monumental shift in the usage of other currently limited diagnostic tests, including Amyloid PET scans and other biomarkers. On today's podcast, we talk about all things Amyloid, including Aducanumab and Amyloid PET scans with Gil Rabinovici. Dr. Rabinovici is the Edward Fein and Pearl Landrith Endowed Professor in Memory & Aging at UCSF. I could talk to Gil all day long, but we try to fit all of these topics in this jam-packed podcast: The heterogeneity of dementia and potentially Alzheimer's disease Where are we now with disease modifying treatments for Alzheimer's disease The Role of Amyloid PET scans and other biomarkers both now and in the future The wild story Aducanumab and the controversy surrounding its pending FDA approval