Podcast appearances and mentions of aaron kesselheim

Abdul and Katelyn discuss the latest in public health including: The FDA's new rules on Covid boosters RFK's claim that Americans shouldn't take his advice Florida's decision to remove fluoride from the drinking water New proposed cuts to Medicaid and SNAP A genetic breakthrough that saved the life of a 9 month old baby Then Abdul talks to prescription drug policy expert Dr. Aaron Kesselheim about Trump's feeble attempt to address drug prices, and what could actually be done to bring them down. NOTE: We are dark next week for the Memorial Day holiday. We will be back with a new episode on June 5. Check out our shop at store.americadissected.com for our new America Dissected merch – including logo shirts, hoodies and mugs. And don't miss our “Vaccines Matter. Science Works.” t-shirts! This show would not be possible without the generous support of our sponsors. America Dissected invites you to check them out. This episode was brought to you by: de Beaumont Foundation: For 25 years, the de Beaumont Foundation has worked to create practical solutions that improve the health of communities across the country. To learn more, visit debeaumont.org. 

Howie and Harlan are joined by Aaron Kesselheim, a physician, attorney, and public health expert, to discuss the shifting legal landscape for healthcare regulation and his experiences serving on an FDA advisory committee. Harlan reports on the growing evidence of widespread health impacts from microplastics; Howie provides an update on the bird flu outbreak.  Links: Microplastics “Landmark study links microplastics to serious health problems” “Microplastics: Are we facing a new health crisis—and what can be done about it?” “Microplastics are inside us all. What does that mean for our health?” “Microplastics are everywhere—we need to understand how they affect human health” “How do plastics, including microplastics and plastic-associated chemicals, affect human health?” “The potential of micro- and nanoplastics to exacerbate the health impacts and global burden of non-communicable diseases” Aaron Kesselheim PORTAL: Program on Regulations, Therapeutics, and Law “The End of Chevron Deference: What Does It Mean, and What Comes Next?” “Biden Administration Proposes Covering Obesity Drugs In Medicare And Medicaid” “Biden-Harris Administration Announces Medicare Advantage and Medicare Part D Prescription Drug Proposals that Aim to Improve Care and Access for Enrollees” “3 Experts Have Resigned From An FDA Committee Over Alzheimer's Drug Approval” X: Aaron Kesselheim's resignation letter Congressional testimony of Aaron Kesselheim: “The Inflation Reduction Act of 2022: Reducing Excessive Spending and Supporting Patient Access to Brand-Name Drugs while Promoting Meaningful Innovation”  Congressional testimony of Aaron Kesselheim: “How the US Government Supports Meaningful Drug and Device Innovation: Funding Development of Transformative Therapies and Avoiding Excessive Prices for new Products with Limited Benefits” Aaron Kesselheim: “US public investment in development of mRNA covid-19 vaccines: retrospective cohort study” Harvard Online: Prescription Drug Regulation, Cost, and Access: Current Controversies in Context New York Times Weddings/Celebrations: Jennifer Cohn, Aaron Kesselheim Bird flu CDC: USDA Reported H5N1 Bird Flu Detections in US Backyard and Commercial Poultry CDC: H5 Bird Flu: Current Situation “Bird Flu, Explained” “California suspends distribution of Raw Farm raw milk products after bird flu detection” “Canadian probe into teen's critical H5N1 infection finds no clear source” USDA Economic Research Service: Farm Labor Learn more about the MBA for Executives program at Yale SOM. Email Howie and Harlan comments or questions.

Howie and Harlan are joined by Aaron Kesselheim, a physician, attorney, and public health expert, to discuss the shifting legal landscape for healthcare regulation and his experiences serving on an FDA advisory committee. Harlan reports on the growing evidence of widespread health impacts from microplastics; Howie provides an update on the bird flu outbreak.  Links: Microplastics “Landmark study links microplastics to serious health problems” “Microplastics: Are we facing a new health crisis—and what can be done about it?” “Microplastics are inside us all. What does that mean for our health?” “Microplastics are everywhere—we need to understand how they affect human health” “How do plastics, including microplastics and plastic-associated chemicals, affect human health?” “The potential of micro- and nanoplastics to exacerbate the health impacts and global burden of non-communicable diseases” Aaron Kesselheim PORTAL: Program on Regulations, Therapeutics, and Law “The End of Chevron Deference: What Does It Mean, and What Comes Next?” “Biden Administration Proposes Covering Obesity Drugs In Medicare And Medicaid” “Biden-Harris Administration Announces Medicare Advantage and Medicare Part D Prescription Drug Proposals that Aim to Improve Care and Access for Enrollees” “3 Experts Have Resigned From An FDA Committee Over Alzheimer's Drug Approval” X: Aaron Kesselheim's resignation letter Congressional testimony of Aaron Kesselheim: “The Inflation Reduction Act of 2022: Reducing Excessive Spending and Supporting Patient Access to Brand-Name Drugs while Promoting Meaningful Innovation”  Congressional testimony of Aaron Kesselheim: “How the US Government Supports Meaningful Drug and Device Innovation: Funding Development of Transformative Therapies and Avoiding Excessive Prices for new Products with Limited Benefits” Aaron Kesselheim: “US public investment in development of mRNA covid-19 vaccines: retrospective cohort study” Harvard Online: Prescription Drug Regulation, Cost, and Access: Current Controversies in Context New York Times Weddings/Celebrations: Jennifer Cohn, Aaron Kesselheim Bird flu CDC: USDA Reported H5N1 Bird Flu Detections in US Backyard and Commercial Poultry CDC: H5 Bird Flu: Current Situation “Bird Flu, Explained” “California suspends distribution of Raw Farm raw milk products after bird flu detection” “Canadian probe into teen's critical H5N1 infection finds no clear source” USDA Economic Research Service: Farm Labor Learn more about the MBA for Executives program at Yale SOM. Email Howie and Harlan comments or questions.

The Federal Trade Commission's (FTC) oversight role in the pharmaceutical market is critical to the health of patients and the health care system. Aaron Kesselheim, MD, JD, MPH, and JAMA Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, discuss the FTC's policies and legal actions related to alleged misconduct, consolidation, and anticompetitive behavior in the pharmaceutical market. Related Content: Federal Trade Commission Actions on Prescription Drugs, 2000-2022

The US is the only country in the world that doesn't negotiate drug prices. In this episode, Aaron Kesselheim delves into the complexities of America's pharmaceutical landscape, where prescription drug spending is causing challenges for millions who can't afford their medications. Shortages in critical drugs like ADHD medications and saline solutions, exacerbated by a supply chain heavily reliant on imports, leave the U.S. vulnerable during crises like the COVID-19 pandemic, Aaron explains, emphasizing the role of for-profit companies in exacerbating shortages and advocating for the Inflation Reduction Act (IRA) to allow Medicare to negotiate drug prices. Tune in and learn how you can advocate for better access to affordable medications and a more resilient healthcare system! Learn more about your ad choices. Visit megaphone.fm/adchoices

The United States needs to tackle a big issue surrounding the soaring price of prescription medicine. In this episode, Aaron Kesselheim talks about the high cost of prescription medicine in the United States and the various factors contributing to this issue. He discusses the financial struggles of Americans due to increased medicine costs, delves into the reasons behind these prices, and explores recent legislative changes to address the issue. Tune in to learn how the US can unravel the puzzle of high prescription medicine costs! Learn more about the Institute of Healthcare Improvement on its website. Learn more about your ad choices. Visit megaphone.fm/adchoices

Dr. Jessica Ailani talks with Dr. Aaron Kesselheim and Leigh Sharpless about the endpoints used in trials supporting the US FDA approval of medications treating migraine.  Read the related article in Neurology. This episode was sponsored by the ExTINGUISH Trial for NMDAR Encephalitis: Call 844-4BRAIN5 to refer patients.

A quick scan of the news on any given day should remind all of us that natural disasters can strike anywhere at any time. Whether it's massive snowstorms, earthquakes, wildfires, hurricanes or floods, no one is immune when Mother Nature chooses to act up. That's why being prepared for a natural disaster is important for everyone. And if you're living with MS, it's especially important for you to have your family's emergency preparedness plan in place. Senior Medical Advisor to National Disaster Operations at the American Red Cross, Mary Casey-Lockyer, joins me to talk about the things that people living with MS should include in their emergency preparedness plan. We're also talking with Dr. Aaron Kesselheim, a researcher at Harvard's Brigham and Women's Hospital. And if you're on Lemtrada, Dr. Kesselheim could use your help. We have a lot to talk about! Are you ready for RealTalk MS??! This Week: Disaster Preparedness  :22 If you're on Lemtrada, Dr. Aaron Kesselheim could use your help  1:43 Mary Casey-Lockery discusses disaster preparedness for people living with MS  10:49 Share this episode  31:22 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/274 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Take the iConquer MS Caregiver Survey https://realtalkms.com/caregiver Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS Devices https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Android Deviceshttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 274 Guest: Dr. Aaron Kesselheim and Mary Casey-Lockyer Tags: MS, MultipleSclerosis, MSResearch, MSSociety, RealTalkMS Privacy Policy

The Inflation Reduction Act of 2022 is a lot of things…including a healthcare reform bill. Along with extending healthcare subsidies for 13 million people, it also, for the first time, allows Medicare to negotiate prescription drug prices. Abdul lays out what the Inflation Reduction Act means for prescription drug prices and sits down with Prof. Aaron Kesselheim, a physician, attorney, and prescription drug policy expert, to understand what this will mean for America.

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

The quality-adjusted life-year (QALY) combines the expected effects on longevity and the expected effects on quality-of-life into a single standard measure. QALYs are often used as part of cost effectiveness analysis, particularly when analyzing the effectiveness of drugs.QALY as a measurement has received a lot of criticism. It's been criticized in concept or in the specifics of how it's defined or used. This criticism often forms the basis for opposition to price negotiations or any limitations on access to a particular drug. This kind of criticism can make it difficult to reach a consensus on processes that might yield negotiated or regulated drug prices.Leah Rand, a postdoctoral fellow at Harvard Medical School and Brigham and Women's Hospital, joins A Health Podyssey to talk about QALY, its criticism, and how to respond to that criticism.Rand and coauthor Aaron Kesselheim published in the September 2021 issue of Health Affairs a systematic literature review of critiques of QALYs and their relevance to drug health technology assessments. They identify three main categories of ethical and practical critiques of QALYS, including methodological concerns, criticisms of neutrality, and potential discrimination. Rand and Kesselheim conclude that understanding and addressing criticism of the QALY is essential for the move to value-based pricing.Listen as Health Affairs Editor-in-Chief Alan Weil interviews Leah Rand on the pros and cons of the Quality Adjusted Life Year measurement in health policy.Subscribe: RSS | Apple Podcasts | Spotify | Stitcher | Google Podcasts

After decades without progress, this June a new treatment was approved by the US Food and Drugs Administration - Biogen's Aduhelm. Ivana Davidovic looks into why this process has been so controversial that is now under investigation by a federal watchdog. Aaron Kesselheim, a Harvard Medical School professor, served on the FDA's advisory committee that considered Aduhelm and voted against its approval. He explains why he decided to resign from his post and what consequences there could be for future research and also for Medicare and Medicaid for covering such an expensive drug. Geri Taylor has participated in the Aduhelm trial since 2015 and both her and her husband Jim believe that the drug has slowed her decline. Jason Karlawish - a practising physician, co-director of the Penn Memory Centre and the author of The Problem of Alzheimer's book - says that more money should be spent on providing carers for the vast majority of Alzheimer's patients and that people should not be forced to choose between cure and care. PHOTO: 3d illustration of the human brain with Alzheimer's disease/Getty Images

Rules for the regulation of medical devices, such as hip prostheses and implantable defibrillators, are complex and differ from those for drugs. Aaron Kesselheim, MD, JD, MPH, and Jonathan Darrow, SJD, LLM, JD, MBA, both faculty members in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women's Hospital, review device classes and approval pathways used by the US Food and Drug Administration (FDA), and prospects for improvements and reform in the agency's processes. Related Content: FDA Regulation and Approval of Medical Devices

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.  

Abdul dissects the FDA's disastrous decision to approve the new Alzheimer's drug aducanumab despite the evidence that it fails to improve symptoms—and its aftermath and implications for the future of Big Pharma. He speaks with Professor Aaron Kesselheim, a prescription drug policy expert and a former member of the FDA Advisory Panel, who resigned at the FDA ignored the panel's overwhelming opposition to approve it the drug.  Take Crooked's listener survey: crooked.com/survey For a transcript of this episode, please visit crooked.com/americadissected. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Sirota talks with Dr. Aaron Kesselheim, the Harvard researcher who last month touched off national headlines when he resigned from a panel that advises the Food and Drug Administration on drug approvals. Kesselheim resigned because the agency approved a pharmaceutical company's unproven Alzheimer's treatment, even though the panel of overseers was nearly unanimous in finding that the therapy had not displayed compelling evidence that it worked. In a co-authored New York Times oped, Kesselheim warned that "in recent years, under steady pressure from the pharmaceutical industry and the patient groups it funds, the F.D.A. has progressively lowered its standards of effectiveness and safety required for drug approvals."

Quanto podemos Confiar nas agências reguladoras (FDA/ANVISA)? - Programa 717 da SBE - Episódio 096 “Esta pode ser a pior decisão de aprovação (de uma droga) que o FDA fez, que eu me lembre!”. Essas foram as palavras de Dr. Aaron Kesselheim que há 6 anos fazia parte do comitê consultivo independente do FDA para a aprovação de drogas. Segundo ele a aprovação da aducanumab (da empresa Biogen) é errada “por causa de tantos fatores diferentes, começando pelo fato de que não há boas evidências de que a droga funcione”. Por esse caso, além do Dr. Kesselheim, outros 2 membros decidiram se demitir do comitê. O problema não para aí. Ao longo dos anos centenas de medicamentos foram retirados do mercado por causa dos danos que causavam. Abaixo apenas alguns exemplos e os riscos que levaram à retirada de algumas drogas nos EUA: - Vioxx (rofecoxib) - aumento do risco de ataque cardíaco e derrame; ligada a cerca de 27.785 ataques cardíacos ou mortes cardíacas súbitas entre 20 de maio de 1999 e 2003; -Accutane [Roacutan] (isotretinoína) - aumento do risco de defeitos congênitos, abortos espontâneos... - Meridia (sibutramina) - aumento do risco cardiovascular e de acidente vascular cerebral; - Xigris (drotrecogin alfa) - Sepse grave e choque séptico; A lista é gigante e receio que isso possa piorar! Muitos profissionais da saúde interpretam a aprovação de drogas de uma maneira simplista, delegando o julgamento de usar ou não para o OK de uma agência reguladora: “Foi aprovado, posso usar.” Mas outra parte faz uma leitura ainda pior: “Foi aprovado, DEVO prescrever! Seria má prática não prescrever!” Entenda uma coisa: essas agências são formadas por pessoas, assim como eu e você, sujeitas a vieses, medos, erros, interesses próprios e a pressões externas (políticas, de indústrias e de grupos de pacientes que exigem mais rapidez na aprovação). Se você quer saber como você pode tomar mais cuidado para não lesar seus clientes, te convido para o 717 da SBE de amanhã (17/06 às 7h17 da manhã - ao vivo no youtube). Eu mostrei como devemos agir diante de novas drogas e os cuidados que temos que ter. Isso é SBE na Prática Clínica. #717daSBE

It's now 100 days since the first COVID shot was given in the largest mass vaccination campaign in U.S. history. With more than 2 million shots administered daily, more vaccines are going in arms each day in America than in all of the clinical trials combined. Each vaccine's clinical trial had 30,000-40,000 participants and was required to produce data for at "least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-risk profile." Today, that means we are getting more and more real-world data from a larger and more diverse group than any clinical trial could ever hope to produce. And as vaccine makers continue to seek FDA authorization, the real-world data also require intense scrutiny. According to the CDC, the current vaccine safety monitoring program is one of the most intense ever. But how does it work — and is it intense enough? Aaron Kesselheim, MD, JD, MPH, professor of medicine at Harvard Medical School and Brigham and Women's Hospital in Boston, joins us on this week's episode to answer that question and explain the possible shortfalls, as well as what you should know if you need to report something.

TESTO DELL'ARTICOLO ➜http://www.bastabugie.it/it/articoli.php?id=6417IL ''SACRO'' VACCINO: UNA COLOSSALE OPERAZIONE PROPAGANDISTICAIl vaccino viene presentato come ''luce e speranza'', ma in realtà è un salto nel vuoto che non ci salveràdi Paolo GulisanoIl 27 dicembre 2020 passerà alla storia come il V Day- Ovvero il Vaccination Day: il giorno in cui in tutta Europa venne scatenata contro il Covid la controffensiva del vaccino. Una sorta di Sbarco in Normandia. E' stato annunciato in termini così enfatici e retorici dalla Presidente tedesca della Commissione Europea: "Il Vaccination Day è un toccante momento di unità. La vaccinazione è la via d'uscita duratura dalla pandemia", ha scritto la Von Der Leyen in una nota pubblicata su Twitter. Tecnicamente, le dosi del vaccino Pfizer/Biontech sono già state tutte consegnate ai Paesi della Ue, e giusto all'indomani può avere inizio la campagna di vaccinazione, in simultanea in tutti gli Stati membri per dare un segno di coesione e sottolineare la svolta, come ha precisato il capo dell'esecutivo europeo, sottolineando che da oggi si inizia a voltare pagina. "La vaccinazione ci riporterà gradualmente alla normalità", ha concluso ricordando di continuare a rispettare le norme igieniche di sicurezza finché l'obiettivo della campagna di vaccinazione non sarà raggiunto. Il V Day è dunque un evento anzitutto di grande valore simbolico, funzionale ad una colossale operazione propagandistica. Sappiamo bene che la propaganda, la strategia comunicativa, è uno dei cardini del Great Reset.UNA CAMPAGNA MEDIATICA PER RIMUOVERE OGNI DUBBIO SUI VACCINI ANTI COVIDCon il V Day non iniziano solo le procedure di vaccinazione, ma soprattutto inizia una campagna mediatica il cui scopo è rimuovere ogni dubbio sui vaccini anti Covid, convincere l'opinione pubblica della loro efficacia, sicurezza, e persino la loro doverosità morale e civile. Con il V Day si giunge alla conclusione di un lungo, capillare lavoro fatto dai media e dai social, per conto dei singoli governi e ora dalla stessa UE, per dare una precisa e univoca lettura dell'epidemia, che in sintesi può essere riassunta come segue:Siamo di fronte ad un microrganismo di inusitata letalità. «Nei confronti della malattia causata da questo microrganismo non c'è alcuna cura. Solo un vaccino ci può salvare»Per mesi queste sono state le parole d'ordine inculcate nella popolazione, con una forza e una determinazione che hanno sovrastato le voci libere di scienziati e di operatori della salute che erano in grado di dimostrare che le cose non stavano così: che la letalità del virus non era quella con cui si cercava di terrorizzare le persone, e che la malattia era curabile con tutta una serie di farmaci, tutti invariabilmente negati. Così alla fine siamo arrivati al terzo punto, la soluzione finale.A breve l'ente regolatorio europeo darà il proprio benestare ai vaccini di altre case farmaceutiche. Tutti hanno passato l'esame. Un successo incredibile, unico nella centenaria storia delle vaccinazioni. Tutti funzionano benissimo, e sono sicuri.La storia della Medicina mostra molti esempi di gravi eventi avversi da vaccini immessi sul mercato in periodi di enormi pressioni e aspettative. Ci sono stati vaccini antipolio contaminati nel 1955, casi di sindrome di Guillain-Barré nei destinatari di vaccini antinfluenzali nel 1976 e narcolessia legata a una marca di vaccino antinfluenzale nel 2009.I VACCINI COVID-19 SALVERANNO VITE?L'efficacia e la sicurezza dei vaccini immessi sul mercato saranno le parole che verranno ripetute per convincere i cittadini europei a sottoporsi alle vaccinazioni. Eppure persistono seri dubbi sull'uno e sull'altro di questi fondamentali criteri. Su un numero recente dell'autorevole British Medical Journal (BMJ 2020 371) intitolato Will covid-19 vaccines save lives? Current trials aren't designed to tell us ("I vaccini covid-19 salveranno vite? Le prove attuali non sono progettate per dircelo") ci rivela che nessuno degli studi di Fase III è stato impostato per provare l'efficacia dei vaccini sulla riduzione di esiti gravi come ricoveri ospedalieri, uso di cure intensive o decessi. Né i vaccini vengono studiati per determinare se possono interrompere la trasmissione del virus."L'individuazione di eventi avversi rari gravi richiederà lo studio di decine di migliaia di pazienti, ma questo requisito non sarà soddisfatto dall'adozione precoce di un prodotto che non ha completato la sua valutazione di prova completa", hanno dichiarato i ricercatori della Harvard Drug Policy Jerry Avorn e Aaron Kesselheim.Gli studi sul vaccino Covid-19 sono attualmente progettati per classificare i risultati finali di efficacia una volta che 150-160 partecipanti allo studio sviluppano il covid-19 sintomatico e la maggior parte degli studi ha specificato almeno un'analisi ad interim che consente di terminare gli studi con ancora meno dati accumulati. Non disponiamo dunque di elementi sufficienti per valutare i benefici e i danni dei vaccini. Servirebbe ancora molto tempo e molti studi. Ma ormai la macchina vaccinale è lanciatissima, a tutta velocità. Il vaccino anti Covid, d'altra parte, non è più un farmaco. È molto di più: è "luce e speranza", e con questa aura di discutibile pseudo sacralità va incontro alla sua realizzazione.Il V Day, anziché essere un Vaccination Day, rischia di essere un Vacuum Day, il giorno del salto nel vuoto.Nota di BastaBugie: l'autore del precedente articolo, Paolo Gulisano, nell'articolo seguente dal titolo "Lo scontro tra le due medicine" spiega l'emergere di due tipi di medicina. Una dalla parte dei pazienti e una di Stato dalla parte di chi detiene il potere e lo può dispensare ai propri leali collaboratori.Ecco la parte conclusiva dell'articolo pubblicato su La Nuova Bussola Quotidiana il 19 dicembre 2020:In riferimento allo spettacolo che il mondo medico sta offrendo di sé: che tipo di Scienza è la Medicina? È davvero così tutto relativo, opinabile, e alla fine ha ragione chi ha in mano le leve del potere, compresa quella della comunicazione?L'epidemia in realtà sta facendo emergere due diversi tipi di Medicina, contrapposti e forse addirittura inconciliabili tra loro.Da una parte c'è una Medicina - o meglio: dei medici - interpreti di una lunga tradizione di arte medica - l'arte del prendersi cura - che ha inizio con Ippocrate, Medici che si dedicano alla cura dei malati, e che di conseguenza cercano realisticamente, di fronte ad una situazione di emergenza, di diffusa sofferenza, di intervenire con tutte le proprie capacità, con tutte le proprie conoscenze, con tutte le evidenze scientifiche note, per curare e per guarire i malati. Sono nate così le varie che la Bussola ha portato a conoscenza dei lettori: i singolo medici, le equipe, i gruppi, che hanno messo in comune esperienze di cure efficaci. Una Medicina ippocratica, personalista, umanistica.Dall'altra parte c'è una Medicina burocratica, spersonalizzata, collettivistica. La Medicina dei protocolli. Intesi non come linee guida utili alla pratica diagnostica e terapeutica, ma come rigidi e inamovibili paletti normativi, indifferenti alle nei confronti di nuove scoperte, di nuove evidenze scientifiche. Indifferenti al fatto che si possa guarire e salvare tante persone: ciò che conta è la letteratura, le pubblicazioni, gli studi a doppio cieco, lavori scientifici che magari richiedono anni, mentre la gente muore qui ed ora, ed in attesa di validazioni da parte dei consessi autorevoli, non riceve altro che antipiretici sintomatici in attesa che la malattia evolva verso forme gravi, spesso fatali.La prima Medicina è quella che ha messo in campo tutta la propria determinazione a curare le persone, la seconda è quella che ha sentenziato che non c'è cura: ci può essere solo la prevenzione basata sull'isolamento, sulla reclusione domiciliare, e quindi la prevenzione (non la cura) basata sui vaccini, vaccini da accogliere con fede cieca, senza discussioni, senza richiedere letteratura e pubblicazioni e studi accurati. Una Medicina di Stato, che non ammette discussioni, che pretende obbedienza cieca, pronta e assoluta. Da una parte una Medicina di umili e generosi professionisti, i cui nomi sono sconosciuti al grande pubblico: dall'altra parte una Medicina dei nuovi divi televisivi, dei ricercatori da salotto, dei maestri delle boutades.Una Medicina dalla parte dei pazienti, e una Medicina dalla parte di chi detiene il potere, e lo può dispensare ai propri leali collaboratori.Voi a chi affidereste la vostra salute? Titolo originale: Il ''sacro'' vaccino, un salto nel vuoto che non ci salveràFonte: La Nuova Bussola Quotidiana, 27-12-2020Pubblicato su BastaBugie n. 697

Interview with Aaron Kesselheim, author of Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs, and Francis J. Crosson, M.D., author of Managing the Cost of Medicare Part B Drugs: Implications for the Program and Beneficiaries

Interview with Aaron Kesselheim, author of Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs, and Francis J. Crosson, M.D., author of Managing the Cost of Medicare Part B Drugs: Implications for the Program and Beneficiaries

Americans pay more money – sometimes much more money – for prescriptions than consumers in many other wealthy countries. Why? The drivers are many and complicated. Pharmaceutical companies, employers, health care providers, patients, lawmakers, and pharmacy benefit managers all play a role. Calls to make prescriptions more affordable have prompted new efforts, including at the federal level. Last May, for example, President Trump introduced a plan intended to help reduce drug prices. This Forum event aimed to demystify the prescription drug pricing process. Experts weighed issues such as regulation, price negotiation and competitive market pressures, ultimately asking why prescription costs matter for public health. Part of The Dr. Lawrence H. and Roberta Cohn Forums, this event was presented jointly with Reuters on September 26, 2018.

The passage of the 21st Century Cures Act has drawn both applause and criticism. A sweeping bipartisan effort with multiple components, the law dramatically boosts funding for medical research, particularly in areas such as cancer and brain disease. The law also relaxes regulatory processes for pharmaceuticals and medical devices. In doing so, the law's supporters point to the potential for faster treatments benefiting from a streamlined approval process. Critics raise concerns that safety and efficacy might be compromised, with potentially devastating consequences. And the law also has been questioned for failing to explicitly address high drug prices, a growing public issue. These debates are unfolding as the Trump administration is expected to imminently announce its choice for a new FDA commissioner, who will head an agency directly impacted by the Cures act. In this Forum, experts will explore the implications of the law for biomedicine, regulation, pharmaceuticals and patient advocacy. This Forum event was presented jointly with STAT on February 27, 2017. Watch the entire series at ForumHSPH.org.

Drug prices continue to rise in the US. Many solutions have been proposed but few have been implemented. Drs. Janet Woodcock from the FDA and Aaron Kesselheim, author of The High Cost of Prescription Drugs in the United States from the Harvard Medical School discuss the role of brand name drugs and generics and how they influence the cost of pharmaceuticals. Also see The Cost of US Pharmaceutical Price Reductions: A Financial Simulation Model of R&D Decisions by Thomas A. Abbott and John A. Vernon.

Drug prices continue to rise in the US. Many solutions have been proposed but few have been implemented. Drs. Janet Woodcock from the FDA and Aaron Kesselheim, author of The High Cost of Prescription Drugs in the United States from the Harvard Medical School discuss the role of brand name drugs and generics and how they influence the cost of pharmaceuticals. Also see The Cost of US Pharmaceutical Price Reductions: A Financial Simulation Model of R&D Decisions by Thomas A. Abbott and John A. Vernon.  

This episode features Aaron S. Kesselheim of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital discussing the 21st Century Cures Act. Read his commentary in CPT here. Listen and subscribe for free on iTunes and Google Play

This episode features Aaron S. Kesselheim of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital discussing the 21st Century Cures Act. Read his commentary in CPT here. Listen and subscribe for free on iTunes and Google Play

In the eighth installment of the OFID podcast, Editor Paul Sax, MD, delves into the headline-making pyrimethamine (Daraprim) saga where Turing Pharmaceuticals increased the price of the recently-acquired toxoplasmosis drug from $13 to $750 a pill. Aaron Kesselheim, MD, JD, MPH, and Joel Gallant, MD, MPH, join the discussion to shed light on what is unique about the generic drug market in the U.S. that makes these dramatic price increases possible and if there will be any resolution.

Aaron Kesselheim is an associate professor of medicine at Harvard Medical School and a member of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. A. Sarpatwari, J. Avorn, and A.S. Kesselheim. Progress and Hurdles for Follow-on Biologics. N Engl J Med 2015;372:2380-2.

Two articles on bmj.com look at high risk devices for rare conditions, and how the US Food and Drug Administration regulates them. Joining us to discuss the problems are Rita Redberg, professor of medicine at the University of California San Francisco, and Aaron Kesselheim, assistant professor of medicine at the Harvard School of Public health. Read the articles Presumed safe no more: lessons from the Wingspan saga on regulation of devices http://www.bmj.com/content/348/bmj.g93 Assessment of US pathway for approving medical devices for rare conditions http://www.bmj.com/content/348/bmj.g217

Dr. Aaron Kesselheim is an assistant professor in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital and Harvard Medical School. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. A.S. Kesselheim and J. Karlawish. Biomarkers Unbound - The Supreme Court's Ruling on Diagnostic-Test Patents. N Engl J Med 2012;366:2338-40.