FDA Appointee Is a Notorious Drug Critic With a Lot to Prove
The controversial appointment of oncologist Vinay Prasad — an outspoken critic of the pharmaceutical industry and US health agencies — to a key role within the Food and Drug Administration was a shock for drug companies. Biotech stocks immediately fell over fears that the bar for drug approvals suddenly got a lot higher.
Tightening regulatory standards is a reasonable goal. But achieving it requires delicately balancing evidence and compassion, weighing certainty against speed. Prasad has had a lot to say over the years about how companies and the FDA have gotten that balance wrong. Now, as the director of the Center for Biologics Evaluation and Research, which oversees vaccines, gene therapies and the blood supply, he has to prove that he can get it right.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
30 minutes ago
- Yahoo
Fresenius Medical starts US commercialisation of haemodiafiltration system
Fresenius Medical Care (FME) has commenced the US commercialisation of its high-volume haemodiafiltration (HVHDF) kidney replacement therapy, 5008X CAREsystem. The full-scale commercial launch is anticipated by the company in 2026. FME secured the Food and Drug Administration's (FDA) 510(k) clearance last week for the updated HDF-capable system. In February 2024, FME first obtained the clearance for the 5008X CAREsystem, enabling focused testing and clinical assessments. The latest clearance approves additional features, including the Fresenius Clinical Data Exchange (CDX), which facilitates ONE-TOUCH access to medical information systems, eliminating the need for extra computer stations. The CDX claims to optimise clinic workflows, mitigate cross-contamination risks, and reduce citations under the CMS V-tag by streamlining data access and freeing up the clinic area by minimising the cabling clutter. Over the coming months, FMS' Care Delivery patient care business segment will start providing HDF dialysis therapy in chosen first wave clinics within its US Fresenius Kidney Care dialysis clinics network. This gradual rollout will continue throughout the year. The 5008X CAREsystem, paired with the FDA-approved FX CorAL dialyser, represents a leap in medical device innovation by Fresenius. It not only enables HVHDF but also introduces enhancements in workflow and therapy. The CONVINCE study, funded by the EU and conducted across eight European countries, found that subjects undergoing HVHDF had a significant 23% reduction in death rates against those receiving high-flux haemodialysis. FME CEO Helen Giza said: 'Last week's FDA clearance of our updated 5008X CAREsystem with additional features was a critical milestone in our work to improve the lives of people living with kidney disease by bringing industry-leading, HVHDF dialysis therapy to the US. 'Haemodiafiltration is already the treatment standard across much of Europe, Latin America, and Asia, and we are very well experienced with it. Our great familiarity with this treatment, combined with the outcome and promising results of the external CONVINCE research study, reiterated the significant patient health and well-being benefits available with HVHDF.' "Fresenius Medical starts US commercialisation of haemodiafiltration system" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Medscape
31 minutes ago
- Medscape
Novel Survey Effectively Screens Binge Eating in Diabetes
A new diabetes-specific 10-item screening tool demonstrated excellent performance in detecting binge eating disorder in both patients with type 1 diabetes (T1D) and those with type 2 diabetes (T2D), showing strong associations with glycaemic control and mental health outcomes. METHODOLOGY: Although diabetes-specific screening for disordered eating behaviours is advised, the only available tool — the Diabetes Eating Problem Survey–Revised (DEPS-R) — is tailored for patients with T1D on rapid-acting insulin therapy, limiting its applicability across other diabetes types and treatment regimens. Researchers developed a 10-item non–insulin-specific version of the DEPS-R (DEPS-10) and evaluated its screening performance for binge eating disorder in 679 patients with T1D or T2D (mean age, 53.8 years) who had the disease for at least 1 year. The new survey assessed loss of control over eating, dietary and purging behaviours, and challenges in diabetes management. Researchers conducted a receiver operating characteristic curve analysis to test the screening performance of the DEPS-10 and compared it with those of the original DEPS-R and the Problem Areas In Diabetes (PAID) scale. TAKEAWAY: The point prevalence of binge eating disorder was 3.5% in the whole cohort, 2.9% in patients with T1D, and 4.3% in those with T2D. The DEPS-10 showed excellent screening performance for binge eating disorder (area under the curve [AUC], 0.92; P < .001), matching that of the DEPS-R (AUC, 0.92; P < .001) and surpassing that of the PAID scale (AUC, 0.82; P < .001). < .001), matching that of the DEPS-R (AUC, 0.92; < .001) and surpassing that of the PAID scale (AUC, 0.82; < .001). The DEPS-10 showed optimal sensitivity (87.5%) and specificity (86.9%) for detecting binge eating disorder at a cutoff score of greater than or equal to 15; participants with this cutoff score had higher body mass index and A1c level along with a greater psychological burden than those with scores below it. The stepwise approach of first screening with the PAID scale and then applying the DEPS-10 boosted specificity to 94%, compared with 87% when using the DEPS-10 alone and 67% when using the PAID scale alone. IN PRACTICE: "A two-step approach using the PAID followed by the DEPS-10 can be a feasible and time-efficient procedure in routine care," the authors wrote. SOURCE: This study was led by Laura Yvonne Klinker, Diabetes Center Mergentheim in Bad Mergentheim, Germany. It was published online on May 29, 2025, in Diabetic Medicine . LIMITATIONS: Higher DEPS-10 scores in one fifth of the participants may have been affected by glucagon-like peptide 1 therapy. Additionally, the relatively low positive predictive value of the DEPS-10 could have been attributed to its broader scope in detecting various disordered eating behaviours beyond binge eating disorder. DISCLOSURES: This study was funded by a grant from the German Center for Diabetes Research. The authors reported having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. References Credit Lead image: Anastasiia Torianyk/Dreamstime Medscape News UK © 2025 WebMD, LLC Cite this: Novel Survey Effectively Screens Binge Eating in Diabetes - Medscape - June 05, 2025.
Forbes
35 minutes ago
- Forbes
5 ChatGPT Prompts To Be Generally Happier More Often
Most people spend hours chasing empty dopamine hits from social media, streaming, and shallow conversations. Anxiety ensues, and they wonder why they aren't happy. Days slip away on distractions instead of building the life that brings actual joy. Sound like you? What if a few simple prompts could completely transform your daily experience? Happiness requires intention. It's a simple choice. Stop reacting and start choosing happy. Copy, paste and edit the square brackets in ChatGPT, and keep the same chat window open so the context carries through. You carry subtle stressors that drain your energy every single day. The notifications that interrupt your focus. The commitments you never really wanted. The people who leave you feeling worse after every interaction. Remove these drains and watch your baseline happiness rise. Small stressors compound into major unhappiness over time. Get intentional about identifying them and cutting them out. "Based on what you know about me through our conversations, what are the subtle habits or behaviors that might be causing me low-level stress every day? Look for patterns in my routines, digital habits, work style, and social interactions that could be quietly draining my energy. For each habit you identify, suggest a small, practical change I could make starting tomorrow. Ask for more detail if required." The five people you spend the most time with shape your mood, beliefs, and actions more than anything else. Some lift you up. Others keep you stuck. Your friendship group determines your ceiling in almost every area of life. The wrong influences keep you playing small and feeling bad about yourself. The right ones push you forward and celebrate your wins. "Based on our previous conversations, help me analyze the five people who influence my mood and mindset the most. For each person, assess: 1) Whether they generally elevate or drain my energy, 2) Specific ways they impact my thinking and behavior, and 3) What boundaries or changes might improve our relationship. Then suggest a practical action plan for either strengthening positive influences or managing challenging ones. Encourage me to use voice mode." Your calendar reveals the truth about what you actually value. Not what you say you value. Look at where your time really goes. The meetings you attend. The blocks you schedule. The people you make time for. We often claim to value family, health, or creativity but our calendars tell a different story. Make your time align with your true values. "Analyze what my calendar reveals about my actual values and priorities. Based on our previous conversations, review how I spend my time and identify any misalignments between my stated values and my daily schedule. Then, suggest 3 specific calendar changes that would better reflect what matters most to me. What would a better version of me change? Include both additions (new blocks to create) and subtractions (things to eliminate or reduce): [Upload a screenshot of your calendar] Speed kills happiness. Racing through your days means missing the moments that matter. Always thinking about what's next instead of what's now. But you can choose to operate differently. Joy comes from focus and attention, not from checking more boxes. Take back control of your brain with a proper assessment and plan. "Create a powerful daily planning question that helps me choose joy over speed. The question should prompt me to reconsider how I approach my day, helping me prioritize meaningful experiences and satisfaction over just getting things done quickly. After providing the question, explain why it works psychologically and how it challenges my current patterns. Then, suggest 3 specific moments in my day when I should pause and ask myself this question for maximum impact." Your phone steals your happiness every morning. The moment you reach for it, your brain fills with other people's priorities, and a huge hit of dopamine. Notifications. News. Social media. You start reacting instead of creating. Morning sets the tone for everything that follows. Protect this time and your entire day transforms. Give yourself space to think and feel before consuming. "Based on what you know about me, if I stayed off my phone until 11am each day, what specific improvements might I experience in my mood, productivity, and overall happiness? Create a detailed picture of how my mornings could be different. Then provide 4 practical strategies to help me build and maintain this habit, including how to handle potential challenges like work expectations and the urge to check notifications.' Small changes to your inputs create massive shifts in your happiness. Find the stressors hiding in plain sight and examine the five people influencing you most. Let your calendar show what you really value and make the changes. Choose joy instead of speed and break your phone addiction cycle. Happiness comes from intentional choices every single day. The prompts will point the way. The rest is up to you. Choose your inputs. Remove any reason not to be happy. Watch your life transform. Access my most life-changing ChatGPT prompts.
