Podcasts about off label

Editor's Summary by Kirsten Bibbins-Domingo, PhD, MD, MAS, Editor in Chief, and Preeti Malani, MD, MSJ, Deputy Editor of JAMA, the Journal of the American Medical Association, for articles published from February 1-7, 2025.

 Because of Physical issues and Psychology issues.1.) Low libido.When having a menopausal problem,- the females have a lack of sex hormones or a dry vagina. In these cases, they have pain when they have sex… Or if the body is too fat. 2.) Difficulty being aroused. When women are:stressed out, tired, depressed, too many problems,bad lover,   or have anxiety. -the majority of women don't like under these circumstances to have sex with men.3.) Aversion to sex and/or of men.If a girl is growing up in a family that abuse sex then the girl will have a bad consciousness if it will enjoy sex.On average every 10th girl is sexually abused through their family… In both cases, the sexually abused woman needs a therapy to get rid of all these aversions of sex and traumas. Otherwise, intimacy or a deep connection to her boyfriend or spouse will be a problem.4.) Asexuality. Women who have no or less sex drive… That is possible.5.) Inability to reach orgasm.Up to 10-20% of women never achieve an orgasm.  In all cases exist some remedies… First, check a female doctor. A.) For a low testosterone level, menopause and aging take daily:1.) Maca powder from a high altitude mountain (Andean) (otherwise it will not work!!!).  Maca powder can be very powerful to overcome menopause. Or try Ashwagandha (can't be used during pregnancy). 2.) Ginseng3.) Fo-Ti (He Shou Wu, Chinese Cornbind)4.) Gingko Biloba5.) Goji Berries (Wolf Berries)6.) Astragalar7.) Lingzhi Mushrooms8.) Gotu Kola9.) Jiao Gu Lan The first 5 herbs are increasing your testosterone and other sexual hormones… At least they make your body strong. The last 4 herbs are for busting your immune system and heart…B.) Zesta (a botanical oil to apply to the genitals) to enhance the climax of women.C.) INTONE ™ and Intensity™  are approved electrical stimulating devices that can help to get an orgasm and help to treat the urinary leakage in women. D.) Vaginal estrogen – Available as a cream, a tablet or a vaginal ring, and considered the best treatment for genital arousal problems and pain from vulvovaginal atrophy that occurs in many postmenopausal women.E.) Off-Label use of Vaginal DHEA 1 percent suppository – An adrenal precursor that women with vaginal atrophy/thinning/decreased sensation can use as an alternative to vaginal estrogen.F.) Osphena – The first, non-estrogen oral therapy for moderate to severe painful sexual activity due to vulvovaginal atrophy.G.) Flibanserin (Addyi®) – This drug was recently approved by the FDA to restore female sexual desire in women before menopause. It must be taken orally every day, and it may have side effects, such as severe low blood pressure and fainting.My Video: Why can't women sleep with men? https://youtu.be/zeT3eA_f_T0My Audio: https://divinesuccess.net/wp-content/uploads/2021/Podcast.B/Why-can't-women-sleep-with-men.mp3

Join Lee Henrikson and Dr Jill as they talk about drugs that are being used for multiple issues other than FDA designated use. Understand the FDA process and studies they reference.

FDA has changed its mind about off label marketing. Today, we're diving into how drug and device companies can effectively engage with payers and providers, exploring recent updates and guidelines. Let's start with the basics: FDA Regulations and the First Amendment. The FDA's ability to impose restrictions on speakers and content is limited by the First Amendment, which protects commercial speech. While the FDA can regulate marketing to prevent false or misleading claims, it must balance this with constitutional protections.Next, we discuss the CFL Guidance—focused on medical device and product communications consistent with FDA-required labeling. This guidance helps evaluate whether communications about approved products align with FDA labeling, including considerations for patient populations, usage directions, and potential harm. Despite its existence for six years, companies still face challenges due to high penalties for non-compliance and a lack of concrete steps for implementation.We'll also cover the FDAMA 114 Guidance, which clarifies how manufacturers can share healthcare economic information with payers about both approved and unapproved products. This guidance aims to ensure that communications are truthful, non-misleading, and based on competent and reliable scientific evidence.Additionally, the PIE Act (Prescription Drug and Medical Device Pre-Approval Information Exchange Act) facilitates communication about investigational drugs, allowing for early planning and budgeting by providing data on clinical trial phases and anticipated approval timelines.Finally, we'll touch on the SIUU Guidance, which focuses on communications from firms to healthcare providers about unapproved uses of approved products. This guidance is designed to ensure that such communications are truthful and separate from promotional content, despite the complexities and scrutiny involved.The key takeaways for medical affairs teams are to develop strategies that ensure compliance with these diverse guidelines, addressing both regulatory and legal aspects of communication. For robust support, contact the Kulkarni Law Firm, where we provide expert guidance to navigate these complex issues and ensure compliance.Support the show

Join host Duane Schulthess on the Vital Health Podcast as he explores the groundbreaking Prime Rose Project, an initiative redefining the use of off-label drugs in oncology. Featuring insights from Dr. Hans Gelderblom, Chair of Medical Oncology at Leiden University Medical Center, and Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, a member of the Dutch National Payers Evaluation Committee, this episode delves into the challenges and opportunities of drug rediscovery protocols. Learn how this innovative approach balances accessibility, affordability, and evidence-based treatments, transforming the landscape of personalized medicine across Europe.See omnystudio.com/listener for privacy information.

Eli Lilly's changed its opinion on Off-Label uses! Eli Lilly, a company that makes a diabetes drug, is now urging people not to use it for weight loss, a common off-label use, despite not raising concerns about off-label uses in the past. Off-label use, where a drug is used for something other than its original purpose, is a normal part of healthcare, and the FDA acknowledges this practice. However, Lilly's sudden stance seems driven by a shortage of the drug, which they want to prioritize for diabetes patients. This shift appears more about supply management than safety. It's crucial that companies and regulatory bodies maintain consistent messaging to avoid confusion and ensure patient care remains a priority. Let's continue advocating for what's best for patients.Support the show

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. A study has found that Novo Nordisk's semaglutide may reduce the risk of Alzheimer's disease by 40% to 70%. Roche has entered a potential $1 billion gene therapy deal with Dyno Therapeutics, focusing on neurological diseases. Off-label prescribing of GLP-1 receptor agonists for type 1 diabetes has increased, despite lack of FDA approval. Viking Therapeutics plans to accelerate the development of an obesity drug with two Q4 catalysts. Trilink Biotechnologies has expanded its mRNA synthesis services offerings for screening studies. The USP aims to double its volunteer applicant pool, while a CDC panel recommends pneumococcal vaccines for adults aged 50-64. Updates on companies like Catalent, Sangamo, and Moderna are also included in today's news. Additionally, the FDA has approved Pfizer's Abrysvo as the first RSV vaccine for younger adults.

CME credits: 1.00 Valid until: 15-10-2025 Claim your CME credit at https://reachmd.com/programs/cme/limitations-of-current-treatments-fda-approved-and-off-label-approaches/28625/ Patients with PTSD suffer from a range of psychiatric symptoms that severely reduce their quality of life. PTSD has proven to not only be a complicated diagnosis, but also one that has a low index of suspicion. Many patients are not screened for PTSD, and those who are diagnosed often gain little benefit from currently available treatments. Join us as these issues are dissected by Drs. Joseph Goldberg and Roger McIntyre, with the objective of providing clinicians with key action steps to take to improve outcomes for patients affected by PTSD.

CME credits: 1.25 Valid until: 15-10-2025 Claim your CME credit at https://reachmd.com/programs/cme/safety-efficacy-and-black-box-warnings-challenges-associated-with-off-label-treatments-of-aad/27099/ This series of bite-sized episodes contains important information on diagnosing and treating agitation in Alzheimer's disease (AAD). Drs. Anton Porsteinsson and Brendan Montano discuss best practices for recognizing early symptoms, diagnosing patients, and treating their AAD.

A new medication is knocking on the door for FDA approval in PTSD, and it isn't MDMA. We cover that, and 8 other off label medications.CME: Take the CME Post-Test for this EpisodePublished On: 09/23/2024Duration: 27 minutes, 18 secondsChris Aiken and Kellie Newsome, PMHNP have disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.

This week we speak with noted interventional cardiologist Dr. Shyam Sathanandam of LeBonheur Children's Hospital in Memphis, TN about novel, 'off-label' uses of the Amplatzer Piccolo device in children. In what sorts of lesions does Dr. Sathanandam believe this device offers distinct advantages for vascular closure? What is the feature of this device that allows it to work for small defect closure so effectively and safely? Are there any new changes coming to this device or the delivery system for PDA closure in the premature infant? These are amongst the questions and topics reviewed with our guest this week!https://doi.org/10.1080/14796678.2024.2355057

Encerramos nossa jornada por Oslo, na Noruega, com o final da temporada do podcast Off Label | Sabático, do oftalmologista Paulo Schor.

O penúltimo episódio da nossa jornada pela Noruega já está aqui!

Explorando a Noruega: No Novo Episódio do Podcast Off Label

A viagem pela Noruega continua! Paulo Schor neste episódio nos leva para desbravar curiosidades de Oslo.Começando pela capa desse podcast e os detalhes únicos que tornam o Design Escandinavo único! E ele comentará sobre isso também!Neste terceiro episódio, @PauloSchor explorou aromas e filhos da cidade, aventurando-se pela gastronomia local, além de histórias do Museu Fram e do Centro da Paz. Paulo Schor também visita a Ópera de Oslo e enfrenta os desafios da escalada indoor.Não perca essa tradição na cultura e história norueguesa!

Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams' views on how the FDA can better ensure clinical trial diversity (:27), questions about approving a new drug that would be used with a standard of care regimen that is off-label (15:00), and the agency beginning to schedule fully in-person advisory committee meetings (24:03). More On These Topics From The Pink Sheet ‘You Shall Not Pass:' Former Surgeon General On Why US Government Should Push Trial Diversity: https://pink.citeline.com/PS155063/You-Shall-Not-Pass-Former-Surgeon-General-On-Why-US-Government-Should-Push-Trial-Diversity Gaps Found In Most Pharma Trial Diversity Policies: https://pink.citeline.com/PS155086/Gaps-Found-In-Most-Pharma-Trial-Diversity-Policies Zevra's Arimoclomol Use With Standard Of Care Complicates US FDA Adcomm Efficacy Assessment: https://pink.citeline.com/PS155091/Zevras-Arimoclomol-Use-With-Standard-Of-Care-Complicates-US-FDA-Adcomm-Efficacy-Assessment Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel: https://pink.citeline.com/PS155100/Back-To-White-Oak-US-FDA-Adcomms-Go-Fully-InPerson-Starting-With-Antimicrobials-Panel

No 2º episódio do podcast Off Label | Sabático, Paulo Schor compartilha suas experiências em Oslo, explorando o impacto das parcerias público-privadas na saúde. O objetivo é trazer insights valiosos sobre como sistemas de saúde ao redor do mundo podem se beneficiar dessas colaborações.Vamos juntos refletir sobre os desafios e oportunidades que moldam a medicina globalmente. Espero que vocês aproveitem e participem dessa discussão essencial para o futuro da saúde.

Part 3 of a 3 part series We are thrilled to welcome RN and community member Mandy Baker as she dives into her personal experience taking a GLP-1 off-label brand drug. Mandy is a busy wife, mom of six, and grandma of five. She is a registered nurse and has spent the majority of her life caring for her family and serving in her church and community.  Please check out our part 1 (ep. 223) and part 2 (ep. 226) on this topic. In this episode we discuss: A personal journey with off-label GLP-1 class drugs.  How Mandy felt while taking these drugs. Making lifestyle changes alongside taking the drug. Side-effects of taking the drug. Other ways to educate yourself on this topic and eliminate addictive foods. This is such a thought provoking episode, don't forget to head on over to YouTube to watch it in video. We'd love to know your thoughts on this topic because it really does impact everyone.  **Please note that the information provided in this podcast is not intended to be a substitute for professional medical advice, diagnosis or treatment that can be provided by your own Medical Doctor.   Helpful links and resources: https://www.brightlineeating.com/ Podcasts we mention: Episode 226: Part 2 with Jeff Dachis Episode 223: Part 1 in this series --------------------------------------------------------- Thanks to our amazing Sponsor, Vivarays Are you looking for a way to improve your sleep and boost your energy during the day? Meet Vivarays' Circadian Light Harmonizing Glasses! Unlike regular blue light blockers, these glasses are engineered with a deep understanding of light and its impact on your body. Designed by leading sleep experts, Vivarays helps keep your circadian rhythm in sync with nature, improving your hormonal balance, sleep quality, energy levels and productivity. Head over to https://vivarays.com/livingwell to check out their amazing glasses and use promo code ARTOFLIVINGWELL during checkout to save 10%. --------------------------------------------------------- Invigorating Outdoor Community Yoga with Anne Gustin Tuesday, July 23rd in Edina, 7 PM Sign-up here --------------------------------------------------------- Need more protein in your day? Check out these amazing, high quality products from Kion, especially their essential amino acids, which we both use daily.   Use code 'ARTOFLIVING' for a discount off your purchase. ----------------------------------------------------------- Ask us a question/make a recommentation We'd love to hear from you! Click here to share your feedback and suggestions. ----------------------------------------------------------- Sign-up for your 15 minute Health Transformation Audit - Click here. ----------------------------------------------------------- Revitalize your body and prepare for summer with our self-guided liver detox, designed to leave you feeling refreshed, energized, and ready to embrace the season ahead! We now have a program where you can do it on your own schedule but still receive all the wonderful support and recipes of the full program.  Register here! ----------------------------------------------------------- Let us help you get to the root cause of your unwanted symptoms. Schedule a 15 minute consultation to discuss at-home functional medicine lab testing here. ----------------------------------------------------------- How can you support our podcast? Apple users, please subscribe and review our show on Apple Podcasts,we make sure to read them all. Android users, please be sure to subscribe to our show on Google Podcasts so that you don't miss any of the action. Tell a friend about The Art of Living Well Podcast® and our community programs. Share your favorite episode on social media and don't forget to tag us @theartofliving_well. Subscribe to our Youtube channel Shop our Favorite Products: https://www.theartoflivingwell.us/products Connect with us on social media: IG: @theartofliving_well FB: theartoflivingwell Get on our list so you don't miss out on announcements, programs and events. You can download our guests' favorite reads here. Learn more about your hosts: Marnie Dachis Marmet Stephanie May Potter

Off-label use of dental devices during direct laryngoscopy by AORNJournal

Es ist sehr wichtig sich als Patient*in über die eigenen Behandlungsmöglichkeiten ein wenig auszukennen. Auch mir hat das schon in vielen lebenswichtigen Therapieentscheidungen weitergeholfen. Voraussetzung ist natürlich ein Onkologe*in, der/die sich in Arzt - Patientenkommunikation auf Augenhöhe - und in der Einbindung des Patienten bei der Therapieauswahl (Neudeutsch nennt sich das dann „Share decision making -SDM) auskennt. Prof. Dr. Jürgen Wolf (siehe auch der 115.Talk) von der Uniklinik Köln ist so ein Onkologe. Er berichtet uns über die wichtigsten neuesten Studien zum nicht-kleinzelligen Lungenkrebs (NSCLC) von der ASCO , dem größten internationalen Krebskongress, der Anfang Juni in Chicago stattfand. Damit Du zu deiner Mutation direkt die Informationen findest, die Du brauchst,  habe ich die Zeiten unter dem Podcast aufgelistet. ⚠️Solltest Du Fragen zu einer Studie haben bietet Herr Wolf am Ende dieser Folge seine Unterstützung an. ⚠️Wenn Du Lungenkrebspatient*in oder Angehörige*r bist, dann werde unbedingt Mitglied in der Patientenorganisation zielgenau e.V.. Dieser Verein setzt sich nicht nur für uns ein, sondern arbeitet auch eng mit dem nNGM, Prof. Wolf und der Uniklinik Köln zusammen. Ich wünsche Dir viel Inspiration beim Zuhören und hinterlasse mir auch gerne ein Feedback oder eine Bewertung. Hier kannst Du nach aktuellen Studien suchen: https://nngm.de/studien/ Die Patientenorganisation zielgenau e.V. https://www.zielgenau.org/ 00.00 – 01.50   Intro 01.51 – 04.00 Was ist die ASCO, was die ESMO?  4.01  -   06.10    Wie sind die Studienergebnisse eingeteilt?  6.11 –    7.30 Allgemeine Ergebnisse zum Lungenkrebs 7.31 – 8.05 Neue Entwicklungen allgemein 8.06 - 21.42 EGFR - MUTATION / MET Amplifikation Share Decision Making 21.42 - 28.50 ALK - Mutation 28.51 - 32.39 ROS 1 - Mutation  32.40 - 34.20 Was ist OFF - Label? 34.21 - 36.25 HER 2 Mutation 36.26 - 40.52 K-RAS Mutation 40.53 - 42.40 Forschung & Entwicklung bei Lungenkrebs allgemein WICHTIG 42.36 - 43.00 Korrektur einer Aussage zu ROS-1 / Lorlatinib 43.00 - 46.46 WO bekomme ich nähere Informationen zu Lungenkrebs- Studien --- Send in a voice message: https://podcasters.spotify.com/pod/show/kab4/message

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.We discuss the following:What does off-label mean from a reimbursement standpoint? Lessons from the US v. Eli Lilly 2009 case How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid? How are compounded drugs reimbursed? Could a company be held accountable for off-label use of a drug due to compounded products? Are weight loss drugs exempted from reimbursement? Support the Show.

Jo Cheah chats with clinical pharmacologist Richard Day about off-label prescribing. Ric explains why off-label prescribing occurs, the barriers to getting new indications added to a drug's approved label, and the potential risks of off-label prescribing without sufficient evidence. Read the full article by Richard Day in Australian Prescriber.

**Click Here to join the 21 Day Quick Start and jump start your weight loss journey!**In this episode, Marcelle navigates through the craze, the science, and the societal impact of these medications, armed with insights from a Pew Research survey on American perceptions and the broader conversation on weight management. With a critical eye, she examines the dual role of GLP-1 agonists in regulating blood sugar and suppressing appetite, their initial use for diabetes, and the recent shift towards treating obesity – sparking shortages and ethical debates.In this discussion, Marcelle addresses the widespread skepticism and lawsuits arising from adverse effects, such as gastrointestinal issues and psychiatric problems, tied to these drugs. He challenges the narrative of weight loss being a simple matter of willpower, advocating instead for a holistic approach that considers diet, exercise, stress, and genetics.This episode is not just about questioning the efficacy and safety of weight loss medications. It's about unraveling the multidimensional aspects of weight management, exploring functional medicine perspectives, and uncovering the real stories behind the headlines. Whether you're curious about the science, concerned about the ethical implications, or seeking alternatives for weight management, this podcast offers a comprehensive look at what it really means to tackle obesity in today's world.**Click Here to join the 21 Day Quick Start and jump start your weight loss journey!**

In the US v. Facteau case, a recent development adds complexity to the FDA's ongoing struggle with off-label communications, particularly in light of the SIUU guidance and the CFL guidance. The First Circuit ruled against Facteau, emphasizing the distinction from the Caronia case. Unlike Coronia, where the focus was on broader free speech and off-label promotion issues, the US v. Facteau case centered on the roles and actions of individuals involved. Notably, Facteau's direct executive involvement in promoting off-label uses, coupled with evidence of intent to circumvent FDA regulations, set this case apart. This ruling highlights the nuanced considerations surrounding off-label marketing and underscores the importance of individual actions and intent in legal outcomes.

Watch our episodes on video: https://www.youtube.com/channel/UCSna7385c3Xg_4Too92NKMw Producer: Tara Mei Video Editor: Jacob Keliikoa DISCLAIMER: The information provided on the Optispan YouTube channel is intended solely for general educational purposes and is not meant to be, nor should it be construed as, personalized medical advice. No doctor-patient relationship is established by your use of this channel. The information and materials presented are for informational purposes only and are not a substitute for professional medical advice, diagnosis, or treatment. We strongly advise that you consult with a licensed healthcare professional for all matters concerning your health, especially before undertaking any changes based on content provided by this channel. The hosts and guests on this channel are not liable for any direct, indirect, or other damages or adverse effects that may arise from the application of the information discussed. Medical knowledge is constantly evolving; therefore, the information provided should be verified against current medical standards and practices. The views and opinions expressed in this program are those of the speakers and do not necessarily reflect the policies or positions of Optispan or related entities. Any content is not intended to malign any religion, organization, company, or individual. More places to find us: Twitter: https://twitter.com/optispanpodcast Twitter: https://twitter.com/optispan Twitter: https://twitter.com/mkaeberlein Linkedin: https://www.linkedin.com/company/optispan https://www.optispan.life/ Hi, I'm Matt Kaeberlein. I spent the first few decades of my career doing scientific research into the biology of aging, trying to understand the finer details of how humans age in order to facilitate translational interventions that promote healthspan and improve quality of life. Now I want to take some of that knowledge out of the lab and into the hands of people who can really use it. On this channel I talk about all things aging and healthspan, from supplements and nutrition to the latest discoveries in longevity research. My goal is to lift the veil on the geroscience and longevity world and help you apply what we know to your own personal health trajectory. I care about quality science and will always be honest about what I don't know. I hope you'll find these videos helpful!

Dr. Helveston's new book tells the history of the Clostridium botulinum, a bacterium that was discovered and researched as a poison and how it came to be Botox, with multiple medical applications and a household word in the beauty industry. As an ophthalmologist, Dr. Helveston worked with Alan Scott who is credited with developing and manufacturing Botox although, as you'll hear in the episode, his rewards were more advancing science and having fun rather than making money. It's a fascinating tale of a remarkable person and his dedication to a useful toxin.Eugene Helveson's website:https://eugenehelveston.com/Thoughts? Comments? Potshots? Contact the show at:https://booksshowstunes.discreetguide.com/contact/Sponsored by Discreet Guide Training:https://training.discreetguide.com/Follow or like us on podomatic.com (it raises our visibility :)https://www.podomatic.com/podcasts/books-shows-tunes-mad-actsSupport us on Patreon:https://www.patreon.com/discreetguideJennifer on Post.News:@JenCrittendenJennifer on XTwitter:@DiscreetGuideJennifer on LinkedIn:https://www.linkedin.com/in/jenniferkcrittenden/

Join Prof. Francesco Giorgino and Dr. Shehla Shaikh as they discuss strategies to help support type 2 diabetes patients during cultural events, such as observation of Ramadan. For more free education, go to ⁠⁠⁠⁠diabetes.knowledgeintopractice.com⁠⁠⁠⁠⁠, where you can see all past episodes of the podcast as well as other free CME resources. Follow us on Twitter (⁠⁠⁠⁠@dkipractice⁠⁠⁠⁠⁠) or connect on ⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠⁠. Prof. Francesco Giorgino Grants or contracts: Eli Lilly, Roche Diabetes Care Consulting: Eli Lilly, Novo Nordisk Honoraria for lectures, presentations and education events: Astra-Zeneca, Boehringer-Ingelheim Advisory boards: Eli Lilly, Lifescan, Merck Sharp & Dohme, Medimmune Leadership or fiduciary role in other board: EASD/EFSD, (SIE), Fo.Ri SIE Receipt of equipment, materials, drugs, medical writing, gifts or other services: AstraZeneca, Eli Lilly, Novo Nordisk Unlabelled use of drugs or devices: Roche Diabetes Care, Sanofi Dr. Shehla Shaikh Dr. Shaikh declares no current financial conflict of interest Funding Information: This independent educational activity is supported by an educational grant from Novo Nordisk A/S. The educational content has been developed by Liberum IME in conjunction with an independent steering committee; Novo Nordisk A/S, has had no influence on the content of this education. Accreditation information Liberum IME staff, ACHL staff and others involved with the planning, development, and review of the content for this activity have no relevant affiliations or financial relationships to disclose. ACHL requires that the faculty participating in an accredited continuing education activity disclose all affiliations or other financial relationships within 24 months (1) with the manufacturers of any commercial product(s) and/or provider(s) of commercial services discussed in an educational presentation and (2) with any ineligible companies. All relevant financial relationships have been mitigated prior to this activity. This CME/CE activity might describe the off-label, investigational, or experimental use of medications and/or devices that may exceed their FDA-approved labeling. Physicians should consult the current manufacturers' prescribing information for these products. ACHL requires its speakers to disclose that a product is not labeled for the use under discussion. Discussion of Off-Label, Investigational, or Experimental Drug Use: None

Join Prof. Francesco Giorgino and Dr. Darren McGuire as they discuss personalisation of treatment for patients with both type 2 diabetes and cardiovascular disease. For more free education, go to ⁠⁠⁠⁠⁠diabetes.knowledgeintopractice.com⁠⁠⁠⁠⁠⁠, where you can see all past episodes of the podcast as well as other free CME resources. Follow us on Twitter (⁠⁠⁠⁠⁠@dkipractice⁠⁠⁠⁠⁠⁠) or connect on ⁠⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠⁠⁠. Faculty disclosures Prof. Francesco Giorgino Grants or contracts: Eli Lilly, Roche Diabetes Care Consulting: Eli Lilly, Novo Nordisk Honoraria for lectures, presentations and education events: Astra-Zeneca, Boehringer-Ingelheim Advisory boards: Eli Lilly, Lifescan, Merck Sharp & Dohme, Medimmune Leadership or fiduciary role in other board: EASD/EFSD, (SIE), Fo.Ri SIE Receipt of equipment, materials, drugs, medical writing, gifts or other services: AstraZeneca, Eli Lilly, Novo Nordisk Unlabelled use of drugs or devices: Roche Diabetes Care, Sanofi Dr. Darren K. McGuire Clinical trial leadership: - Former: Esperion, AstraZeneca, CSL Behring - Current: Novo Nordisk, Lilly USA, Pfizer, Boehringer Ingelheim, NewAmsterdam Consultancy: - Former: Merck & Co - Current: Lilly USA, Boehringer Ingelheim, Novo Nordisk, Bayer, Lexicon, Altimmune, Esperion, Intercept Pharmaceuticals, Applied Therapeutics Funding Information: This independent educational activity is supported by an educational grant from Novo Nordisk A/S. The educational content has been developed by Liberum IME in conjunction with an independent steering committee; Novo Nordisk A/S, has had no influence on the content of this education. Accreditation information Liberum IME staff, ACHL staff and others involved with the planning, development, and review of the content for this activity have no relevant affiliations or financial relationships to disclose. ACHL requires that the faculty participating in an accredited continuing education activity disclose all affiliations or other financial relationships within 24 months (1) with the manufacturers of any commercial product(s) and/or provider(s) of commercial services discussed in an educational presentation and (2) with any ineligible companies. All relevant financial relationships have been mitigated prior to this activity. This CME/CE activity might describe the off-label, investigational, or experimental use of medications and/or devices that may exceed their FDA-approved labeling. Physicians should consult the current manufacturers' prescribing information for these products. ACHL requires its speakers to disclose that a product is not labeled for the use under discussion. Discussion of Off-Label, Investigational, or Experimental Drug Use: None

In this episode, the focus is on navigating the complex landscape of off-label information sharing, exploring legal aspects in the context of the life sciences industry. Sponsored by the Kulkarni Law Firm, the episode highlights key points:1. Scientific discussions: Courts are generally cautious about FDA scrutiny in scientific discussions, such as those in academic conferences or scholarly articles, falling within FDA safe harbors.2. Consistent with label guidance from the FDA: Sharing information aligning with the appropriate use of a drug or device, even if not explicitly mentioned, is legally acceptable.3. FDAMA 114:  The guidance emphasizes sharing health economic information, including off-label data, with specific entities.4. SIUU guidance: It introduces a nuanced framework for discussing information implying off-label use, necessitating companies' awareness of its implications.5. Education and non-company representatives: Engaging in discussions independent of pharmaceutical companies, provide crucial avenues for off-label information sharing, avoiding FDA scrutiny.

Off-label medication use and prescribing practices by AORNJournal

Dr. Joe Sirven and Dr. Natohya Mallory share insights on the weight loss drug Ozempic. Then, Jacksonville Today reporter Will Brown explores the life of civil rights patriarch Lloyd Pearson. Finally, we hear about two efforts to revitalize North Springfield and Downtown.

Join Prof. Francesco Giorgino and Dr. Alice Cheng for a discussion on the importance of being culturally sensitive during shared decision-making in type 2 diabetes care. For more free education, go to ⁠⁠diabetes.knowledgeintopractice.com⁠⁠⁠, where you can see all past episodes of the podcast as well as other free CME resources. Follow us on Twitter (⁠⁠@dkipractice⁠⁠⁠) or connect on ⁠⁠LinkedIn⁠⁠⁠. Faculty disclosures Prof. Francesco Giorgino Grants or contracts: Eli Lilly, Roche Diabetes Care Consulting: Eli Lilly, Novo Nordisk Honoraria for lectures, presentations and education events: Astra-Zeneca, Boehringer-Ingelheim Advisory boards: Eli Lilly, Lifescan, Merck Sharp & Dohme, Medimmune Leadership or fiduciary role in other board: EASD/EFSD, (SIE), Fo.Ri SIE Receipt of equipment, materials, drugs, medical writing, gifts or other services: AstraZeneca, Eli Lilly, Novo Nordisk Unlabelled use of drugs or devices: Roche Diabetes Care, Sanofi Dr. Alice Cheng Advisory Board: Abbott, AstraZeneca, Bayer Speakers Bureau: Abbott, Amgen, AstraZeneca, Bausch, Bayer Funding Information: This independent educational activity is supported by an educational grant from Novo Nordisk A/S. The educational content has been developed by Liberum IME in conjunction with an independent steering committee; Novo Nordisk A/S, has had no influence on the content of this education. Accreditation information Liberum IME staff, ACHL staff and others involved with the planning, development, and review of the content for this activity have no relevant affiliations or financial relationships to disclose. ACHL requires that the faculty participating in an accredited continuing education activity disclose all affiliations or other financial relationships within 24 months (1) with the manufacturers of any commercial product(s) and/or provider(s) of commercial services discussed in an educational presentation and (2) with any ineligible companies. All relevant financial relationships have been mitigated prior to this activity. This CME/CE activity might describe the off-label, investigational, or experimental use of medications and/or devices that may exceed their FDA-approved labeling. Physicians should consult the current manufacturers' prescribing information for these products. ACHL requires its speakers to disclose that a product is not labeled for the use under discussion. Discussion of Off-Label, Investigational, or Experimental Drug Use: None

Following a number of challenges to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released new draft guidance document addressing truthful and non-misleading communications for product uses not approved or cleared by the FDA. Notably, the document updates standard for using scientific or medical journal reprints and creates a new category for firm-generated presentations. These changes suggest a potential expansion of the safe harbor for manufacturers' communication of scientific information. In this episode of Connected With Latham, Ben Haas, Global Vice Chair of Latham's Healthcare & Life Sciences Practice Group, speaks with counsel Monica Groat and associate Nate Beaton. They discuss the implications of the FDA's draft guidance document, including the “scientifically sound and clinically relevant” criteria for reprints, the scope of the “firm-generated presentation” definition, and the parts of the document that may be challenged by industry.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Join Prof. Francesco Giorgino and Dr. Erika Bezerra Parente as they identify some takeaways from EASD 2023, including data and discussions on treatment non-adherence, SGLT2 inhibitors, and stigma For more free education, go to ⁠diabetes.knowledgeintopractice.com⁠⁠, where you can see all past episodes of the podcast as well as other free CME resources. Follow us on Twitter (⁠@dkipractice⁠⁠) or connect on ⁠LinkedIn⁠⁠. Faculty disclosures Prof. Francesco Giorgino Grants or contracts: Eli Lilly, Roche Diabetes Care Consulting: Eli Lilly, Novo Nordisk Honoraria for lectures, presentations and education events: Astra-Zeneca, Boehringer-Ingelheim Advisory boards: Eli Lilly, Lifescan, Merck Sharp & Dohme, Medimmune Leadership or fiduciary role in other board: EASD/EFSD, (SIE), Fo.Ri SIE Receipt of equipment, materials, drugs, medical writing, gifts or other services: AstraZeneca, Eli Lilly, Novo Nordisk Unlabelled use of drugs or devices: Roche Diabetes Care, Sanofi Dr. Erika Bezerra Parente Honoraria for lectures, presentations and education events: Sanofi Funding Information: This independent educational activity is supported by an educational grant from Novo Nordisk A/S. The educational content has been developed by Liberum IME in conjunction with an independent steering committee; Novo Nordisk A/S, has had no influence on the content of this education. Accreditation information Liberum IME staff, ACHL staff and others involved with the planning, development, and review of the content for this activity have no relevant affiliations or financial relationships to disclose. ACHL requires that the faculty participating in an accredited continuing education activity disclose all affiliations or other financial relationships within 24 months (1) with the manufacturers of any commercial product(s) and/or provider(s) of commercial services discussed in an educational presentation and (2) with any ineligible companies. All relevant financial relationships have been mitigated prior to this activity. This CME/CE activity might describe the off-label, investigational, or experimental use of medications and/or devices that may exceed their FDA-approved labeling. Physicians should consult the current manufacturers' prescribing information for these products. ACHL requires its speakers to disclose that a product is not labeled for the use under discussion. Discussion of Off-Label, Investigational, or Experimental Drug Use: None

In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns raised by regulatory agencies such as the FDA, DOJ, FTC, and OIG. The discussion revolves around the risk-based review of outward-facing information shared by medical device companies. The podcast delves into seven hierarchical layers that dictate how organizations should approach compliance. These layers include:1. The Constitution (First Amendment): Highlighting the clash between First Amendment rights like free speech and FDA regulations. Emphasizes the importance of truthful and non-misleading information.2. Laws Made by Congress: Discussing how laws such as the Food, Drugs, and Cosmetics Act set the rules but can be ambiguous, potentially leading to regulatory challenges.3. Regulatory Agency Interpretation: Exploring how FDA, FTC, and OIG interpretations through regulations, guidances, and enforcement actions add another layer of compliance focus for Pharma companies.4. CIA Settlements: Examining Integrity Agreements or CIA settlements as legal precedents that set industry wide regulatory expectations for Pharma companies.5. Industry Codes: Discussing voluntary codes like Pharma or AdvaMed codes, which, while not legally binding, may influence industry standards.6. Internal Policies: Highlighting the importance of company-set policies for day-to-day operations, which are more conservative than the law but serve as prudent forms of engagement.7. Personal Risk Tolerance: Acknowledging that individual risk tolerance varies, and while policies guide the process, they won't eliminate personal risk tolerance. The podcast emphasizes the need for companies to navigate these layers carefully and stay informed and compliant. It concludes with an invitation to seek assistance in creating digital health engagement programs by contacting the speaker via email at darshan@kulkarnilawfirm.com Website: http://www.darshantalks.comLaw Firm: http://www.kulkarnilawfirm.comTwitter: https://twitter.com/darshantalksLinkedIn: https://www.linkedin.com/in/darshanku...----Disclaimers:This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relat

A terminal cancer diagnosis can be paralyzing. However, when Jane McLelland was diagnosed with a Stage IV cancer in 1999, she didn't freeze. Using her medical knowledge and researching heavily, Jane put together a cancer-starving formula using natural therapies, exercise, diet, and a unique cocktail of drugs that acted synergistically to kill even the toughest of cancers. In fact, Jane became one of the pioneers in discovering the use of off-label drugs for cancer, mapping the landscape of cancer metabolism in a new way for patients to understand. In today's episode, Jane shares how off-label & repurposed drugs can effectively starve cancer. Jane is truly incredible, and continues to serve as an inspiration and source of encouragement for anyone facing a terminal cancer diagnosis.What you'll learn from this episode: How off-label drugs are now being recognized as an effective cancer treatmentSpecific drug combinations that Jane used to treat her Stage IV cancer diagnosisHow Jane created her famous "metro-map" of drugs to block different cancer pathwaysCancer fuel sourcesSpecific drug combinations that Jane used to block her own cancer& So much more!Resources:Book: How To Starve CancerWebsite | InstagramWarburg Effect (National Library of Medicine, PubMed)Glossary of terms Jane references and moreLINK:  Metro Map ProtocolInternational Doctors familiar with Jane's Metro Map ProtocolTo learn more about WellnStrong: Subscribe to my newsletter! WellnStrong Blog WellnStrong Instagram WellnStrong Pinterest

Pink Sheet reporters and editors discuss new off-label use communications guidance (:35), how price negotiations could impact prescribing (9:49), and Monica Bertagnolli's nomination for NIH director advancing (17:18). More On These Topics From The Pink Sheet Off-Label Guidance Creates ‘Safe Harbor' For Dissemination of Certain Info To HCPs: https://pink.citeline.com/PS149058/Off-Label-Guidance-Creates-Safe-Harbor-For-Dissemination-of-Certain-Info-To-HCPs Underwater: Medicare Negotiated Prices For Part B Cancer Drugs Could Change Prescribing: https://pink.citeline.com/PS149065/Underwater-Medicare-Negotiated-Prices-For-Part-B-Cancer-Drugs-Could-Change-Prescribing Bertagnolli NIH Nomination Advances, But Sanders Will Remain Thorn In Side Of Biden's Health Agenda: https://pink.citeline.com/PS149072/Bertagnolli-NIH-Nomination-Advances-But-Sanders-Will-Remain-Thorn-In-Side-Of-Bidens-Health-Agenda

Is there such a thing as a quick fix? Neil deGrasse Tyson, Chuck Nice, and Gary O'Reilly learn about the science behind a wave of new weight loss drugs, the ethics of Ozempic use, and off-label prescriptions with exercise scientist, Dr. Nick Tiller.For more information on the new book: https://startalkmedia.com/books/NOTE: StarTalk+ Patrons can listen to this entire episode commercial-free here: https://startalkmedia.com/show/miracle-drugs-quick-fixes-with-dr-nick-tiller/Thanks to our Patrons Christian Attwood, Tyler Loveland, Ruhan Periyacheri, Jeff Parker, Ed Thorton, and Dakota Ponder for supporting us this week.Photo Credit: HualinXMN, CC BY-SA 4.0, via Wikimedia Commons

First up, Jillian explores the practice of prescribing drugs for off label use -- a different purpose than what the drug is FDA approved for. Why is it done? What are the risks and benefits? And some things you need to know before you engage in off label drug use. Then, Jillian resumes her role as a world renowned fitness expert and certified nutritionist to dig in to what it means to be over trained. What are the consequences and how can you fix them? Plus, listener questions on everything from the safety of Stevia and how to use a BMR calculator accurately, to top tips to heal sore muscles.For 25% off The Fitness App by Jillian Michaels, go to www.thefitnessapp.com/podcastdealFollow us on Instagram @JillianMichaels and @MartiniCindyJillian Michaels Community: https://www.facebook.com/groups/1880466198675549Email your questions to JillianPodcast@gmail.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Tune in for today's industry updates.

On this Episode 354 of Health Solutions, Shawn & Janet Needham RPh talk to Dr. Robert Seik about using drugs off label. Dr. Seik is a pharmacist in Las Vegas, Nevada. Shawn, Janet and Dr. Seik are discussing FDA approved drugs and off-label drugs, including Ivermectin. 00:00 ~ Introduction 00:22 ~ Shawn & Janet Introduction 01:48 ~ Using drugs off-label 06:07 ~ Usage for viral infections 09:50 ~ Encouraging doctors 14:35 ~ Telemedicine 16:40 ~ pre-FDA drugs 23:58 ~ Paxlovid 26:44 ~ Rebates & PBM's 29:03 ~ FDA approval 32:40 ~ Practitioner mindsets 40:30 ~ Robert's drug-rep experience 43:45 ~ Diet, Veganism & Pesticides 49:20 ~ Red meat & Niacin 54:18 ~ Closing comments 55:22 ~ Contact Dr. Robert Seik EP 354: Dr. Robert Seik Using Drugs Off Label with Shawn & Janet Needham R. Ph. ~ #pharmaceutical #FDA #diet #podcastshow #optimalhealth #healthfreedom #podcast #podcasts #podcastclips #podcasting #medicalcare #HealthCare #PriceTransparency #freemarket #Liberty #Boise #IdahoFalls #Tricities #SiouxFalls #Wenatchee #EducateAndEmpower #NeedhamHealthSolutions #TeamNeedham #ShawnNeedham #HealthSolutions #MosesLakeProfessionalPharmacy #MLRX #SickenedTheBook #ShawnNeedhamRPh #ThinkOutsideTheSystem #OptimalHealthMatters #ItsTime ~ *** #BenShapiro & #DaveRamsey Fans. Learn how to be in the driver's seat for your healthcare choices {not the system or doctors!}

Welcome to the podcast with Dr. Brendan McCarthy! In this episode we address another Q&A, asking if she can use Off-Label Testosterone & Progesterone. Her doctor says no and she's curious if insurance will cover it. Lets dive in! Dr. Brendan McCarthy founded Protea Medical Center in 2002. While he's been the chief medical officer, Protea has grown and evolved into a dynamic medical center serving the Valley and Central Arizona. A nationally recognized as an expert in hormone replacement therapy, Dr McCarthy s the only instructor in the nation who teaches BioHRT on live patients. Physicians travel to Arizona to take his course and integrate it into their own practices. Besides hormone replacement therapy, Dr. McCarthy has spoken nationally and locally before physicians on topics such as weight loss, infertility, nutritional therapy and more. Thank you for tuning in and don't forget to hit that SUBSCRIBE button! Let us know in the COMMENTS if you have any questions or what you may want Dr. McCarthy to talk about next! Check out Dr. Brendan McCarthy's Book! https://www.amazon.com/Jump-Off-Mood-Swing-Hormones/dp/0999649604 --More Links-- Instagram: www.instagram.com/drbrendanmccarthy TikTok: www.tiktok.com/drbrendanmccarthy Clinic Website: www.protealife.com   #hormonereplacementtherapy #hrt #testosterone #hormones #hormonetherapy #hormonebalance #womenshealth #menshealth

This show was recorded 25 May 2023 and can be viewed on our website ⁠⁠here⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠Knowledge Center⁠⁠⁠. Thank you for listening! This panel discussion is all about navigating off-label use and implementing strategies to improve medical device safety. As we all know, ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers. However, one of the key challenges manufacturers face is how to identify and handle off-label use, especially with the transition to MDR 2017/745. During the discussion, our experts in device development, regulatory compliance and clinical evaluation shared insights on how to manage off-label use, reduce indications, define indications and contra-indications, as well expand indications using real-world data from post-market surveillance. We dove into the complexities of post-market surveillance and the importance of PMCF data in identifying off-label use. We also explored strategies for optimizing regulatory efforts while maintaining patient safety. Key questions for our audience include: Have you had to restrict or reduce the indications for your device as part of the transition to MDR 2017/745? Are you struggling to define your indications and contra-indications for your device? Have you started to see examples of off-label use cropping up as your PMCF data comes back in? Are you trying to expand your indications using real-world data from post-market surveillance? Are you struggling to handle instances of off-label use within your risk management process? Our panelists provided valuable insights into these questions and more from the audience! We hope you'll give this show a listen. Panelists: Dr. Tom Melvin, Associate Professor of Medical Device Regulatory Affairs - Trinity College Dublin (former HPRA) Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation - RQM+ Dr. Sally Sennitt, Medical Director, Intelligence and Innovation - RQM+ Ed Ball, Manager, Intelligence and Strategic Execution - RQM+ --- Send in a voice message: https://podcasters.spotify.com/pod/show/deviceadvice/message

Dr. Holly Lofton, a medical weight management specialist joins me to discuss on-label and off-label uses of GLP-1 agonists including Ozempic in this edition of the PV Roundup specialist spotlight.

Go online to PeerView.com/CDT860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. Prurigo nodularis (PN) is a chronic inflammatory skin condition marked by intensely pruritic, hyperkeratotic nodules distributed on the trunk and extremities. Severe itching contributes to scratching, bleeding, thickening of nodules, and scarring. PN can significantly reduce quality of life, affect sleep and mental health, and hamper participation in activities of daily living and social interaction. Until recently, there were no approved treatments for PN, but one agent has been granted a PN indication, and others are in late-stage development. In this activity, based on a recent live symposium, a panel of experts offers personal guidance on the pathophysiology, burden, and new and promising treatment options for PN. The discussion is enhanced by 3D animation depicting PN pathophysiology plus patient videos that provide compelling perspectives on the burdens of the disease and the experience of treatment. Upon completion of this activity, participants should be better able to: Discuss the burden of disease and unmet needs experienced by patients with prurigo nodularis (PN); Explain how a growing understanding of PN pathophysiology has contributed to the development of novel therapeutic strategies; and Develop individualized treatment plans for PN in accordance with current evidence and expert recommendations using current and emerging treatment options as they become available.

A cancer diagnosis is frightening.  A terminal diagnosis can be absolutely paralyzing.  But when  Jane McLelland was diagnosed with a second aggressive cancer in 1999, classified as terminal, she did not freeze.  Instead she dove headfirst into medical research because she knew she had nothing to lose.Fast forward to 2021 and find out how Jane is trying to turn the world of oncology on its ear.  She's not only overcome her diagnoses, but she is thriving and sharing her knowledge that she knows first hand has had a strong, positive impact on her health.This episode will educate, inspire and encourage anyone who may be on a cancer journey today.  Join me as Jane shares about repurposed/off-label drugs, her Metro Map protocol, the effects of "starving cancer" and so much more!Connect with Jane on her website:https://www.howtostarvecancer.com/contact/Suggested Resource Links:BOOK:  How To Starve CancerLINK:  PubMedWarburg Effect (National Library of Medicine, PubMed)Glossary of terms Jane references and moreLINK:  Metro Map Protocol (podcast)International Doctors familiar with Jane's Metro Map Protocol

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 into law. This omnibus law is over 4,100 pages, and, like many omnibus bills, affects a broad range of issues.According to Dr. Joel M. Zinberg, physician and health care expert, one such issue is the practice of medicine, as a nineteen-line section relating to the authority of the Food & Drug Administration (FDA) may fundamentally change the future viability of off-label prescriptions. Dr. Zinberg joins us in this podcast to explain the Act's provisions concerning the FDA, the possible implications on the practice of medicine, and possible solutions to the potential pitfalls posed by these new health care provisions.Featuring: Joel Zinberg, Senior Fellow, Competitive Enterprise InstituteVisit our website – www.RegProject.org – to learn more, view all of our content, and connect with us on social media.*******As always, the Federalist Society takes no position on particular legal or public policy issues; all expressions of opinion are those of the speaker.

“1 in 5 prescriptions are written for an off-label use” writes Dr. Joel Zinberg. But a section of the new spending bill could take away a physician's ability to use their clinical judgement when writing prescriptions – and CA's AB2098 could muzzle doctors' speech even more. Dr. Joel Zinberg – an expert on the crossroads between medicine and law – discusses LIVE on Ask Dr. Drew. Dr. Joel M. Zinberg, M.D., J.D. is a senior fellow with the Competitive Enterprise Institute. He is a native New Yorker who recently completed two years as General Counsel and Senior Economist at the Council of Economic Advisers in the Executive Office of the President. He practiced general and oncologic surgery in New York for nearly 30 years at the Mount Sinai Hospital and Icahn School of Medicine where he is an Associate Clinical Professor of Surgery. Dr. Zinberg taught for 10 years at the Columbia University Law School as a Lecturer in Law where he created a course on the legal, policy and ethical issues surrounding organ transplantation. He received his J.D. degree from the Yale Law School, his M.D. from the Columbia University College of Physicians and Surgeons and his B.A. in economics with High Honors, Phi Beta Kappa, from Swarthmore College. Learn more about Dr. Zinberg at https://cei.org/experts/joel-zinberg/ 「 SPONSORED BY 」 • BIRCH GOLD - Don't let your savings lose value. You can own physical gold and silver in a tax-sheltered retirement account, and Birch Gold will help you do it. Claim your free, no obligation info kit from Birch Gold at https://birchgold.com/drew • GENUCEL - Using a proprietary base formulated by a pharmacist, Genucel has created skincare that can dramatically improve the appearance of facial redness and under-eye puffiness. Genucel uses clinical levels of botanical extracts in their cruelty-free, natural, made-in-the-USA line of products. Get 10% off with promo code DREW at https://genucel.com/drew 「 MEDICAL NOTE 」 The CDC states that COVID-19 vaccines are safe, effective, and reduce your risk of severe illness. Hundreds of millions of people have received a COVID-19 vaccine, and serious adverse reactions are uncommon. Dr. Drew is a board-certified physician and Dr. Kelly Victory is a board-certified emergency specialist. Portions of this program will examine countervailing views on important medical issues. You should always consult your personal physician before making any decisions about your health.  「 ABOUT the SHOW 」 Ask Dr. Drew is produced by Kaleb Nation (https://kalebnation.com) and Susan Pinsky (https://twitter.com/firstladyoflove). This show is for entertainment and/or informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment. 「 GEAR PROVIDED BY 」 • BLUE MICS - Find your best sound at https://drdrew.com/blue • ELGATO - See how Elgato's lights transformed Dr. Drew's set: https://drdrew.com/sponsors/elgato/ 「 ABOUT DR. DREW 」 For over 30 years, Dr. Drew has answered questions and offered guidance to millions through popular shows like Celebrity Rehab (VH1), Dr. Drew On Call (HLN), Teen Mom OG (MTV), and the iconic radio show Loveline. Now, Dr. Drew is opening his phone lines to the world by streaming LIVE from his home studio. Watch all of Dr. Drew's latest shows at https://drdrew.tv Learn more about your ad choices. Visit megaphone.fm/adchoices

Diabetes drug Ozempic has appealed to celebrities and influencers seeking weight loss, and the pharmaceutical “diet” is riding a TikTok, Twitter, and Instagram wave. Former FDA Commissioner Dr. Scott Gottlieb says, while it may be effective for some, the risks and side effects could be more likely in patients taking it off-label. The ‘Twitter Files' saga continues, as more internal documents from the social media platform emerge publicly. Representative Ro Khanna (D-CA) addresses the next steps for regulating tech and Sam Bankman-Fried's decision to testify at FTX's upcoming hearing. Plus, Amazon has launched a TikTok-style feed of content, Arizona Senator Kyrsten Sinema is leaving the Democratic Party to become Independent, and pet-owners are pushing Chewy's stock higher.  In this episode:Scott Gottlieb @ScottGottliebMDRo Khanna @RoKhannaBecky Quick @BeckyQuickJoe Kernen, @JoeSquawkAndrew Ross Sorkin, @andrewrsorkinKatie Kramer, @Kramer_Katie