Podcasts about European Medicines Agency

HSE MidWest's Patient Advocate says he's shocked and concerned over the continued lack of access to cancer medicines here. A new report from the Irish Pharmaceutical Healthcare Association shows that just 25% of new cancer medicines are available in Ireland, the second-lowest rate in Europe. Of the 56 oncology medicines licensed by the European Medicines Agency since 2020, just 14 are available here. Lahinch-based Healthcare Campaigner John Wall who's living with Prostate Cancer and has been forced to travelled abroad for treatment has been telling Clare FM's Daragh Dolan that patient outcomes are suffering as a result.

A large U.S. study found no evidence that taking Ozempic or Wegovy is tied to an increase in suicidal thoughts, researchers reported recently. 研究人员最近报道说，一项大型美国研究没有发现证据表明服用Ozempic或Wegovy与自杀思想的增加有关。 Both Ozempic for type 2 diabetes and the obesity treatment Wegovy have the same active ingredient, semaglutide. 用于2型糖尿病的Ozempic和肥胖治疗Wegovy具有相同的活性成分，semaglutide。The analysis included electronic medical record data from more than 1.8 million patients. Researchers actually found a lower risk of new and recurring suicidal thoughts in those taking semaglutide compared to those using other medications for weight loss or diabetes. 该分析包括来自180万患者的电子病历数据。 研究人员实际上发现，与使用其他药物减肥或糖尿病的药物相比，在服用半卢替肽的人中，新的和反复出现的自杀思想的风险较低。 Semaglutide belongs to a class of drugs known as GLP-1 agonists, which were designed to treat type 2 diabetes. In addition to helping control blood sugar levels, the drugs produce a feeling of fullness. 半卢宾属于一类称为GLP-1激动剂的药物，这些药物旨在治疗2型糖尿病。 除了帮助控制血糖水平外，这些药物还会产生一种饱满感。 Concerns over reports of suicidal ideation connected with semaglutide led to an investigation by the European Medicines Agency. The U.S. Food and Drug Administration (FDA) has listed suicidal ideation as a possible safety concern for GLP-1 drugs. 人们对与Semaglutide有关的自杀念头的报道的担忧导致了欧洲药品局的调查。 美国食品药品监督管理局（FDA）已将自杀意念列为GLP-1药物的安全问题。 A Reuters examination last year found that the FDA had received 265 reports of suicidal thoughts or behavior in patients taking semaglutide or similar medicines since 2010. Thirty-six of those reports describe a death by suicide or suspected suicide. 路透检查员去年的一项检查发现，自2010年以来，FDA收到了265例服用Semaglutide或类似药物的患者的自杀念头或行为的报告。这些报告中有36例描述了自杀或怀疑自杀的死亡。 Such events do not prove a connection between a drug and a side effect. But they can signal to officials a need to study a specific risk. 此类事件不能证明药物与副作用之间的联系。 但是他们可以向官员发出信号，需要研究特定的风险。The study appeared online in the journal Nature. It was funded by the U.S. National Institutes of Health. The researchers examined data on 240,258 U.S. patients prescribed Wegovy or other medications for weight loss and nearly 1.6 million with type 2 diabetes prescribed Ozempic or other treatments. 该研究在《自然》杂志上在线出现。 它由美国国立卫生研究院资助。 研究人员检查了有关240,258名美国患者的数据，以减肥或其他药物为160万例服用Wegovy或其他药物，并使用了2型糖尿病开处方的Ozempic或其他治疗方法。

In this podcast recorded in early February, David Phizackerley and Julian Treadwell (DTB Associate Editor) provide an overview of the March 2025 issue of DTB. Julian talks about his work as an academic GP based at Bristol University. He explains why and how he developed the GP Evidence website (https://gpevidence.org/) as a resource for health professionals to use as part of a shared decision making process, and talks about the importance of providing patients with information on the absolute benefits and harms of different treatment options for long-term conditions.   The editorial discusses a paper published in The Lancet on the population-health impact of new drugs recommended by NICE and highlights the tension between NICE's role in ensuring that treatments are a cost-effective use of taxpayers' money and its role in championing the for-profit life-sciences - https://dtb.bmj.com/content/63/3/34. A DTB Select item summarises safety alerts issued by the US Food and Drug Administration and the European Medicines Agency on liver problems associated with fezolinetant (▼Veoza), a drug licensed for the treatment of moderate-to-severe vasomotor symptoms associated with the menopause - https://dtb.bmj.com/content/63/3/36. The main article provides an overview of systemic anticancer treatments and conventional cytotoxic drugs - https://dtb.bmj.com/content/63/3/37.   Links GP Evidence (https://gpevidence.org/)   Naci H, Murphy P, Woods B, et al. Population-health impact of new drugs recommended by the National Institute for Health and Care Excellence in England during 2000–20: a retrospective analysis. The Lancet 2025;405:50–60. (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02352-3/fulltext)    Please subscribe to the DTB podcast to get episodes automatically downloaded to your mobile device and computer. Also, please consider leaving us a review or a comment on the DTB Podcast iTunes podcast page. If you want to contact us please email dtb@bmj.com. Thank you for listening.

The Netherlands has emerged as one of Europe's most vibrant and interconnected biotech ecosystems, home to over 1,797 life science companies, world-class pharmaceutical manufacturers, and the European Medicines Agency. With its strategic location, exceptional infrastructure, and collaborative spirit, the country has become known as 'what industry leaders call 'Europe's connected life sciences & health metropolis'. Ahead of CDMO Live 2025, which takes place in Rotterdam's historic World Trade Center this May, we gathered insights from three leaders at the heart of the Netherlands' biotechnology sector. Wieteke Wouters, Program Director at hollandbio, which represents over 260 biotech companies; Esther Peters, Director of Leiden Bio Science Park, the country's largest life sciences hub; and Ellen Smit, Managing Director of Rotterdam Square, the organisation behind the emerging health tech campus in Rotterdam, shared their perspectives on what makes the Dutch biotech ecosystem uniquely successful. Read the full article

About two years ago, we released a podcast with Dr. Thomas Wadden of the University of Pennsylvania describing work on a new generation of medications to treat diabetes and obesity. They were really taking the field by storm. Since then, much more is known since many additional studies have been published and so many people have been using the drugs. So many, in fact, the market value of the Danish company, Novo Nordisk, one of the two major companies selling the drugs, has gone up. It is now greater than the entire budget of the country of Denmark. This single company is responsible for about half of Denmark's economic expansion this year. So, a lot of people are now taking the drugs and this is a great time for an update on the drugs. And we're fortunate to have two of the world's leading experts join us: Dr. Wadden, Professor of Psychology and Psychiatry at the University of Pennsylvania School of Medicine and the inaugural Albert J. Stunkard Professor of Psychiatry at Penn. Joining us as well as Dr. Robert Kushner, a physician and professor of medicine at Northwestern University and a pioneer in testing treatments for obesity. Interview Summary Tom, you and I were colleagues at Penn decades ago. And I got frustrated the treatments for obesity didn't work very well. People tended to regain the weight. And I turned my attention to prevention and policy. But you hung in there and I admired you for that patience and persistence. And Bob, the same for you. You worked on this tenacious problem for many years. But for both of you, your patience has been rewarded with what seems to me to be a seismic shift in the way obesity and diabetes can be treated. Tom, I'll begin with you. Is this as big of a deal as it seems to me? Well, I think it is as big of a deal as it seems to you. These medications have had a huge impact on improving the treatment of type 2 diabetes, but particularly the management of obesity. With older medications, patients lost about 7 percent of their starting weight. If you weighed 200 pounds, you'd lose about 15 pounds. That was also true of our best diet and exercise programs. You would lose about 7 percent on those programs with rigorous effort. But with the new medications, patients are now losing about 15 to 20 percent of their starting body weight at approximately one year. And that's a 30-to-40-pound loss for a person who started at 200 pounds. And with these larger weight losses, we get larger improvements in health in terms of complications of obesity. So, to quote a good friend of mine, Bob Kushner, these medications have been a real game changer. Thanks for putting that in perspective. I mean, we're talking about not just little incremental changes in what treatments can produce, which is what we've seen for years. But just orders of magnitude of change, which is really nice to see. So, Bob what are these medications that we're talking about? What are the names of the drugs and how do they work? Well, Kelly, this transformation of obesity really came about by finding the target that is really highly effective for obesity. It's called the gut brain axis. And when it comes to the gut it's starting off with a naturally occurring gut hormone called GLP 1. I think everyone in the country's heard of GLP 1. It's released after we eat, and it helps the pancreas produce insulin, slows the stomach release of food, and reduces appetite. And that's where the obesity story comes in. So pharmaceutical companies have taken this hormone and synthesized it, something similar to GLP 1. It mimics the action of GLP 1. So, you could actually take it and give it back and have it injected so it augments or highlights this hormonal effect. Now, that same process of mimicking a hormone is used for another gut hormone called GIP that also reduces appetite. These two hormones are the backbone of the currently available medication. There's two on the market. One is called Semaglutide. That's a GLP 1 analog. Trade name is Wegovy. Now, it's also marketed for diabetes. Tom talked about how it is used for diabetes and increases insulin. That trade name is Ozempic. That's also familiar with everyone around the country. The other one that combined GLP 1 and GIP, these two gut hormones, so it's a dual agonist, the trade name for obesity is called Zep Bound, and the same compound for diabetes is called Mounjaro. These are terms that are becoming familiar, I think, to everyone in the country. Tom mentioned some about the, how much weight people lose on these drugs, but what sort of medical changes occur? Just to reiterate what Tom said, I'll say it in another way. For Semaglutide one third of individuals are losing 20 percent of their body weight in these trials. For Tirzepatide, it even outpaces that. And I got a third of individuals losing a quarter of their body weight. These are unheard of weight losses. And with these weight losses and these independent effects from weight, what we're seeing in the trials and in the clinic is that blood pressure goes down, blood sugar goes down, blood fats like triglyceride go down, inflammation in the body goes down, because we marked that with CRP, as well as improvement in quality of life, which we'll probably get to. But really interesting stuff is coming out over the past year or two or so, that it is improving the function of people living with congestive heart failure, a particular form called a preserved ejection fraction. We're seeing improvements in sleep apnea. Think of all the people who are on these CPAP machines every night. We're seeing significant improvements in the symptoms of sleep apnea and the apneic events. And lastly, a SELECT trial came out, that's what it was called, came out last year. Which for the very first time, Kelly, found improvements in cardiovascular disease, like having a heart attack, stroke, or dying of cardiovascular disease in people living with obesity and already have cardiovascular disease. That's called secondary prevention. That, Tom, is the game changer. Bob, I'd like to go back to Tom in a minute but let me ask you one clarifying question about what you just said. That's a remarkable array of biological medical benefits from these drugs. Just incredible. And the question is, are they all attributable to the weight loss or is there something else going on? Like if somebody lost equal amounts of weight by some other means, would these same changes be occurring? Those studies are still going on. It's very good. We're thinking it's a dual effect. It's the profound amount of weight loss, as Tom said. Fifteen to 21 to even 25 percent of average body weight. That is driving a lot of the benefits. But there also appear to be additional effects or weight independent effects that are working outside of that weight. We're seeing improvements in kidney function, improvement in heart disease, blood clotting, inflammation. And those are likely due to the gut hormone effect independent of the weight itself. That still needs to be sorted out. That's called a mitigation analysis where we try to separate out the effects of these drugs. And that work is still underway. Tom, one of the most vexing problems, over the decades that people have been working on treatments for obesity, has been long term results. And I'm curious about how long have people been followed on these drugs now? What are the results? And what was the picture before then? How do what we see now compared to what you saw before? The study that Bob just mentioned, the SELECT trial followed people for four years on Semaglutide. And patients achieve their maximal weight loss at about one year and they lost 10 percent of their weight. And when they were followed up at four years still on treatment, they still maintained a 10 percent weight loss. That 10 percent is smaller than in most of the trials, where it was a 15 percent loss. But Dr. Tim Garvey showed that his patients in a smaller trial lost about 15 percent at one year and while still on medication kept off the full 15 percent. I think part of the reason the weight loss in SELECT were smaller is because the study enrolled a lot of men. Men are losing less weight on this medication than women. But to your question about how these results compare to the results of earlier treatment, well with behavioral treatment, diet, and exercise back in the 70s beyond, people lost this 7 or 8 percent of weight. And then most people on average regain their weight over one to three years. And the same was true of medication. People often stopped these earlier medications after 6 to 12 months, in part because they're frustrated the losses weren't larger. Some people were also worried about the side effects. But the long and short is once you stop taking the medication, people would tend to regain their weight. And some of this weight regain may be attributable to people returning to their prior eating and activity habits. But one of the things we've learned over the past 20 years is that part of the weight regain seems to be attributable to changes in the body's metabolism. And you know that when you lose weight, you're resting metabolic rate, which is the number of calories your body burns at rest to maintain basic bodily functions. Your resting metabolic rate decreases by 10 to 15 percent. But also, your energy expenditure, the calories you burn during exercise decreases. And that may decrease by as much as 20 to 30 percent. So, people are left having to really watch their calories very carefully because of their lower calorie requirements in order to keep off their lost body weight. I think one thing these new drugs may do is to attenuate the drop both in resting metabolic rate and energy expenditure during physical activity. But the long and short of it is that if you stay on these new medications long term, you'll keep off your body weight. And you'll probably keep it off primarily because of improvements in your appetite, so you have less hunger. And as a result, you're eating less food. I'd like to come back to that in a minute. But let me ask a question. If a person loses weight, and then their body starts putting biological pressure on them to regain, how come? You know, it's disadvantageous for their survival and their health to have the excess weight. Why would the body do that? Well, our bodies evolved in an environment of food scarcity, and our physiology evolved to protect us against starvation. First, by allowing us to store body fat, a source of energy when food is not available. And second, the body's capacity to lower its metabolism, or the rate at which calories are burned to maintain these basic functions like body temperature and heart rate. That provided protection against food scarcity. But Kelly, you have described better than anybody else that these ancient genes that regulate energy expenditure and metabolism are now a terrible mismatch for an environment in which food is plentiful, high in calories, and available 24 by 7. The body evolved to protect us from starvation, but not from eating past our calorie needs. And so, it's this mismatch between our evolution and our appetite and our body regulation in the current, what you have called toxic food environment, when you can eat just all the time. I guess you could think about humans evolving over thousands of years and biology adapting to circumstances where food was uncertain and unpredictable. But this modern environment has happened really pretty rapidly and maybe evolution just hasn't had a chance to catch up. We're still existing with those ancient genes that are disadvantageous in this kind of environment. Bob back to the drugs. What are the side effects of the drugs? Kelly, they're primarily gastrointestinal. These are symptoms like nausea, diarrhea, constipation, heartburn, and vomiting. Not great, but they're generally considered mild to moderate, and temporary. And they primarily occur early during the first four to five months when the medications are slowly dose escalated. And we've learned, most importantly, how to mitigate or reduce those side effects to help people stay on the drug. Examples would be your prescriber would slow the dose escalation. So. if you're having some nausea at a particular dose, we wait another month or two. The other, very importantly, is we have found that diet significantly impacts these side effects. When we counsel patients on these medications, along with that comes recommendations for dietary changes, such as reducing fatty food and greasy food. Reducing the amount of food you're consuming. Planning your meals in advance. Keeping well hydrated. And very importantly, do not go out for a celebration or go out to meals on the day that you inject or at least the first two days. Because you're not going to tolerate the drug very well. We use that therapeutically. So, if you want to get control on the weekends, you may want to take your injection on a Friday. However, if weekends are your time out with friends and you want to socialize, don't take it on a Friday. Same thing comes with a personal trainer, by the way. If you're going to have a personal trainer on a Monday where he's going to overwork you, don't take the injection the day before. You'll likely be nauseated, you're not eating, you're not hydrating. So actually, there's a lot that goes into not only when to take the dose and how to take the dose, but how to take it to the best ability to tolerate it. Two questions based on what you said. One is you talked about these are possible side effects, but how common are they? I mean, how many people suffer from these? Well, the trials show about 25 to 45 percent or so of individuals actually say they have these symptoms. And again, we ask them mild, moderate, severe. Most of them are mild to moderate. Some of them linger. However, they really do peak during the dose escalation. So, working with your prescriber during that period of time closely, keeping contact with them on how to reduce those side effects and how you're doing out of medication is extremely important. And the second thing I wanted to ask related to that is I've heard that there's a rare but serious potential side effect around the issue of stomach paralysis. Can you tell us something about that? I mentioned earlier, Kelly, that these medications slow gastric emptying. That's pretty much in everybody. In some individuals who may be predisposed to this, they develop something called ileus, and that's the medical term for gastric paralysis. And that can happen in individuals, let's say who have a scleroderma, who have longstanding diabetes or other gastrointestinal problems where the stomach really stopped peristalsis. In other words, it's moving. That's typically presented by vomiting and really unable to move the food along. We really haven't seen much of that. We looked at the safety data in a SELECT trial that Tom mentioned, which was 17,000 individuals, about 8,000 or so in each group. We really did not see a significant increase in the ileus or what you're talking about in that patient population. Okay, thanks. Tom had alluded to this before, Bob, but I wanted to ask you. How do you think about these medicines? If somebody takes them, and then they stop using the medicines and they gain the weight back. Is that a sign that the medicine works or doesn't work? And is this the kind of a chronic use drug like you might take for blood pressure or cholesterol? That's a great way of setting up for that. And I like to frame it thinking of it as a chronic progressive disease, just like diabetes or hypertension. We know that when you have those conditions, asthma could be another one or inflammatory bowel disease, where you really take a medication long term to keep the disease or condition under control. And we are currently thinking of obesity as a chronic disease with dysfunctional appetite and fat that is deposited in other organs, causing medical problems and so on. If you think of it as a chronic disease, you would naturally start thinking of it, like others, that medication is used long term. However, obesity appeared to be different. And working with patients, they still have this sense 'that's my fault, I know I can do it, I don't want to be on medication for the rest of my life for this.' So, we have our work cut out for us. One thing I can say from the trials, and Tom knows this because he was involved in them. If we suddenly stop the medication, that's how these trials were definitely done, either blindly or not blindly, you suddenly stop the medication, most, if not all of the participants in these trials start to regain weight. However, in a clinical practice, that is not how we work. We don't stop medication suddenly with patients. We go slowly. We down dose the medication. We may change to another medication. We may use intermittent therapy. So that is work that's currently under development. We don't know exactly how to counsel patients regarding long term use of the medications. I think we need to double down on lifestyle modification and counseling that I'm sure Tom is going to get into. This is really work ahead of us, how to maintain medication, who needs to be on it long term, and how do we actually manage patients. Tom, you're the leading expert in the world on lifestyle change in the context of obesity management. I mean, thinking about what people do with their diet, their physical activity, what kind of thinking they have related to the weight loss. And you talked about that just a moment ago. Why can't one just count on the drugs to do their magic and not have to worry about these things? Well, first, I think you can count on the drugs to do a large part of the magic. And you may be surprised to hear me say that. But with our former behavioral treatments of diet and exercise, we spent a lot of time trying to help people identify how many calories they were consuming. And they did that by recording their food intake either in paper and pencil or with an app. And the whole focus of treatment was trying to help people achieve a 500 calorie a day deficit. That took a lot of work. These medications, just by virtue of turning down your appetite and turning down your responsiveness to the food environment, take away the need for a lot of that work, which is a real blessing. But the question that comes up is, okay, people are eating less food. But what are they eating? Do these medications help you eat a healthier diet with more fruits and vegetables, with lean protein? Do you migrate from a high fat, high sugar diet to a Mediterranean diet, or to a DASH like diet? And the answer is, we don't know. But obviously you would like people to migrate to a diet that's going to be healthier for you from a cardiovascular standpoint, from a cancer risk reduction standpoint. One of the principal things that people need to do on these medications is to make sure they get plenty of protein. And so, guidance is that you should have about 1 gram of dietary protein for every kilogram of body weight. If you're somebody who weighs 100 kilograms, you should get 100 grams of protein. And what you're doing is giving people a lot of dietary protein to prevent the loss of bodily protein during rapid weight loss. You did a [00:20:00] lot of research with me back in the 80s on very low-calorie diets, and that was the underpinning of treatment. Give people a lot of dietary protein, prevent the loss of bodily protein. The other side of the equation is just physical activity, and it's a very good question about whether these medications and the weight loss they induce will help people be more physically active. I think that they will. Nonetheless for most people, you need to plan an activity schedule where you adopt new activities, whether it's walking more or going to the gym. And one thing that could be particularly helpful is strength training, because strength training could mitigate some of the loss of muscle mass, which is likely to occur with these medications. So, there's still plenty to learn about what is the optimal lifestyle program, but I think people, if they want to be at optimal health will increase their physical activity and eat a diet of fruits and vegetables, leaner protein, and less ultra processed foods. Well, isn't it true that eating a healthy diet and being physically active have benefits beyond their impact on your ability to lose the weight? You're getting kind of this wonderful double benefit, aren't you? I believe that is true. I think you're going to find that there are independent benefits of being physical activity upon your cardiovascular health. There are independent benefits of the food that you're eating in terms of reducing the risk of heart attack and of cancer, which has become such a hot topic. So, yes how you exercise and what you eat makes a difference, even if you're losing weight. Well, plus there's probably the triple one, if you will, from the psychological benefit of doing those things, that you do those things, you feel virtuous, that helps you adhere better as you go forward, and these things all come together in a nice picture when they're working. Tom, let's talk more about the psychology of these things. You being a psychologist, you've spent a lot of time doing research on this topic. And of course, you've got a lot of clinical experience with people. So as people are losing weight and using these drugs, what do they experience? And I'm thinking particularly about a study you published recently, and Bob was a coauthor on that study that addressed mental health outcomes. What do people experience and what did you find in that study? I think the first things people experience is improvements in their physical function. That you do find as you've lost weight that you've got less pain in your knees, you've got more energy, it's easier to get up the stairs, it's easier to play with the children or the grandchildren. That goes a long way toward making people feel better in terms of their self-efficacy, their agency in the life. Big, big improvement there. And then, unquestionably, people when they're losing a lot of weight tend to feel better about their appearance in some cases. They're happy that they can buy what they consider to be more fashionable clothes. They get compliments from friends. So, all of those things are positive. I'm not sure that weight loss is going to change your personality per se, or change your temperament, but it is going to give you these physical benefits and some psychological benefits with it. We were happy to find in the study you mentioned that was conducted with Bob that when people are taking these medications, they don't appear to be at an increased risk of developing symptoms of depression or symptoms of suicidal ideation. There were some initial reports of concern about that, but the analysis of the randomized trials that we conducted on Semaglutide show that there is no greater likelihood of developing depression or sadness or suicidal ideation on the medication versus the placebo. And then the FDA and the European Medicines Agency have done a full review of all post marketing reports. So, reports coming from doctors and the experience with their patients. And in looking at those data the FDA and the European Medicines Agency have said, we don't find a causal link between these medications and suicidal ideation. With that said, it's still important that if you're somebody who's taking these medications and you start them, and all of a sudden you do feel depressed, or all of a sudden you do have thoughts like, maybe I'd be better off if I weren't alive any longer, you need to talk to your primary care doctor immediately. Because it is always possible somebody's having an idiosyncratic reaction to these medications. It's just as possible the person would have that reaction without being on a medication. You know, that, that can happen. People with overweight and obesity are at higher risk of depression and anxiety disorders. So, it's always going to be hard to tease apart what are the effects of a new medication versus what are just the effects of weight, excess weight, on your mood and wellbeing. You know, you made me think of something as you were just speaking. Some people may experience negative effects during weight loss, but overall, the effects are highly positive and people are feeling good about themselves. They're able to do more things. They fit in better clothes. They're getting good feedback from their environment and people they know. And then, of course, there's all the medical benefit that makes people feel better, both psychologically and physically. Yet there's still such a strong tendency for people to regain weight after they've lost. And it just reinforces the fact that, the point that you made earlier, that there are biological processes at work that govern weight and tendency to regain. And there really is no shame in taking the drug. I mean, if you have high blood pressure, there's no shame in taking the drug. Or high cholesterol or anything else, because there's a biological process going on that puts you at risk. The same thing occurs here, so I hope the de-shaming, obesity in the first place, and diabetes, of course, and then the use of these medications in particular might help more people get the benefits that is available for them. I recommend that people think about their weight as a biologically regulated event. Very much like your body temperature is a biologically regulated event, as is your blood pressure and your heart rate. And I will ask people to realize that there are genetic contributors to your body weight. just as there are to your height. If somebody says, I just feel so bad about being overweight I'll just talk with them about their family history of weight and see that it runs in the family. Then I'll talk to them about their height. Do you feel bad about being six feet tall, to a male? No, that's fine. Well, that that's not based upon your willpower. That's based upon your genes, which you received. And so, your weight, it's similarly based. And if we can use medications to help control weight, cholesterol, blood pressure, blood sugar, let's do that. It's just we live in a time where we're fortunate to have the ability to add medications to help people control health complications including weight. Bob, there are several of the drugs available. How does one think about picking between them? Well, you know, in an ideal medical encounter, the prescriber is going to take into consideration all the factors of prescribing a medication, like any other medication, diabetes, hypertension, you name the condition. Those are things like contraindication to use. What other medical problems does the patient have that may benefit the patient. Patient preferences, of course and side effects, safety, allergies, and then we have cost. And I'll tell you, Kelly, because of our current environment, it's this last factor, cost, that's the most dominant factor when it comes to prescribing medication. I'll have a patient walk in my room, I'll look at the electronic medical record, body mass index, medical problems. I already know in my head what is going to be the most effective medication. That's what we're talking about today. Unfortunately, I then look at the patient insurance, which is also on the electronic medical record, and I see something like Medicaid or Medicare. I already know that it's not going to be covered. It is really quite unfortunate but ideally all these factors go into consideration. Patients often come in and say, I've heard about Ozempic am I a candidate for it, when can I get it? And unfortunately, it's not that simple, of course. And those are types of decisions the prescriber goes through in order to come to a decision, called shared decision making with the patient. Bob, when I asked you the initial question about these drugs, you were mentioning the trade name drugs like Mounjaro and Ozempic and those are made by basically two big pharmaceutical companies, Novo Nordisk and Eli Lilly. But there are compounded versions of these that have hit the scene. Can you explain what that means and what are your thoughts about the use of those medications? So compounding is actually pretty commonly done. It's been approved by the FDA for quite some time. I think most people are familiar with the idea of compounding pharmacies when you have a child that must take a tablet in a liquid form. The pharmacy may compound it to adapt to the child. Or you have an allergy to an ingredient so the pharmacy will compound that same active ingredient so you can take it safely. It's been approved for long periods of time. Anytime a drug is deemed in shortage by the FDA, but in high need by the public, compounding of that trade drug is allowed. And that's exactly what happened with both Semaglutide and Tirzepatide. And of course, that led to this compounding frenzy across the country with telehealth partnering up with different compounding pharmacies. It's basically making this active ingredient. They get a recipe elsewhere, they don't get it from the company, they get this recipe and then they make the drug or compound it themselves, and then they can sell it at a lower cost. I think it's been helpful for people to get the drug at a lower cost. However, buyer beware, because not all compounded pharmacies are the same. The FDA does not closely regulate these compounded pharmacies regarding quality assurance, best practice, and so forth. You have to know where that drug is coming from. Kelly, it's worth noting that just last week, ZepBound and Mounjaro came off the shortage list. You no longer can compound that and I just read in the New York Times today or yesterday that the industry that supports compounding pharmacies is suing the FDA to allow them to continue to compound it. I'm not sure where that's going to go. I mean, Eli Lilly has made this drug. However, Wegovy still is in shortage and that one is still allowed to be compounded. Let's talk a little bit more about costs because this is such a big determinant of whether people use the drugs or not. Bob, you mentioned the high cost, but Tom, how much do the drugs cost and is there any way of predicting what Bob just mentioned with the FDA? If the compounded versions can't be used because there's no longer a shortage, will that decrease pressure on the companies to keep the main drug less expensive. I mean, how do you think that'll all work out? But I guess my main question is how much these things cost and what's covered by insurance? Well first how much do the drugs cost? They cost too much. Semaglutide, known in retail as Wegovy, is $1,300 a month if you do not have insurance that covers it. I believe that Tirzepatide, known as ZepBound, is about $1,000 a month if you don't have insurance that covers that. Both these drugs sometimes have coupons that bring the price down. But still, if you're going to be looking at out of pocket costs of $600 or $700 or $800 a month. Very few people can afford that. The people who most need these medications are people often who are coming from lower incomes. So, in terms of just the future of having these medications be affordable to people, I would hope we're going to see that insurance companies are going to cover them more frequently. I'm really waiting to see if Medicare is going to set the example and say, yes, we will cover these medications for anybody with a BMI of 40 or a BMI of 35 with comorbidities. At this point, Medicare says, we will only pay for this drug if you have a history of heart attack and stroke, because we know the drug is going to improve your life expectancy. But if you don't have that history, you don't qualify. I hope we'll see that. Medicaid actually does cover these medications in some states. It's a state-by-state variation. Short of that, I think we're going to have to have studies showing that people are on these medications for a long time, I mean, three to five years probably will be the window, that they do have a reduction in the expenses for other health expenditures. And as a result, insurers will see, yes, it makes sense to treat excess weight because I can save on the cost of type 2 diabetes or sleep apnea and the like. Some early studies I think that you brought to my attention say the drugs are not cost neutral in the short-term basis of one to two years. I think you're going to have to look longer term. Then I think that there should be competition in the marketplace. As more drugs come online, the drug prices should come down because more will be available. There'll be greater production. Semaglutide, the first drug was $1,300. Zepbound, the second drug Tirzepatide, $1,000. Maybe the third drug will be $800. Maybe the fourth will be $500. And they'll put pressure on each other. But I don't know that to be a fact. That's just my hope. Neither of you as an economist or, nor do you work with the companies that we're talking about. But you mentioned that the high cost puts them out of reach for almost everybody. Why does it make sense for the companies to charge so much then? I mean, wouldn't it make sense to cut the price in half or by two thirds? And then so many more people would use them that the company would up ahead in the long run. Explain that to me. That's what you would think, for sure. And I think that what's happened right now is that is a shortage of these drugs. They cannot produce enough of them. Part of that is the manufacturing of the injector pens that are used to dispense the drug to yourself. I know that Novo Nordisk is building more factories to address this. I assume that Lilly will do the same thing. I hope that over time we will have a larger supply that will allow more people to get on the medication and I hope that the price would come down. Of course, in the U. S. we pay the highest drug prices in the world. Fortunately, given some of the legislation passed, Medicare will be able to negotiate the prices of some of these drugs now. And I think they will negotiate on these drugs, and that would bring prices down across the board. Boy, you know, the companies have to make some pretty interesting decisions, don't they? Because you've alluded to the fact that there are new drugs coming down the road. I'm assuming some of those might be developed and made by companies other than the two that we're talking about. So, so investing in a whole new plant to make more of these things when you've got these competitor drugs coming down the road are some interesting business issues. And that's not really the topic of what we're going to talk about, but it leads to my final question that I wanted to ask both of you. What do you think the future will bring? And what do you see in terms of the pipeline? What will people be doing a year from now or 2 or 5? And, you know, it's hard to have a crystal ball with this, but you two have been, you know, really pioneers and experts on this for many years. You better than anybody probably can answer this question. Bob, let me start with you. What do you think the future will bring? Well, Kelly, I previously mentioned that we finally have this new therapeutic target called the gut brain axis that we didn't know about. And that has really ushered in a whole new range of potential medications. And we're really only at the beginning of this transformation. So not only do we have this GLP 1 and GIP, we have other gut hormones that are also effective not only for weight loss, but other beneficial effects in the body, which will become household names, probably called amylin and glucagon that joins GLP 1. And we not only have these monotherapies like GLP 1 alone, we are now getting triagonists. So, we've got GIP, GLP 1, and glucagon together, which is even amplifying the effect even further. We are also developing oral forms of GLP 1 that in the future you could presumably take a tablet once a day, which will also help bring the cost down significantly and make it more available for individuals. We also have a new generation of medications being developed which is muscle sparing. Tom talked about the importance of being strong and physical function. And with the loss of lean body mass, which occurs with any time you lose weight, you can also lose muscle mass. There's drugs that are also going in that direction. But lastly, let me mention, Kelly, I spend a lot of my time in education. I think the exciting breakthroughs will not be meaningful to the patient unless the professional, the provider and the patient are able to have a nonjudgmental informative discussion during the encounter without stigma, without bias. Talk about the continuum of care available for you, someone living with obesity, and get the medications to the patient. Without that, medications over really sit on the shelf. And we have a lot of more work to do in that area. You know, among the many reasons I admire the both of you is that you've, you've paid a lot of attention to that issue that you just mentioned. You know, what it's like to live with obesity and what people are experiencing and how the stigma and the discrimination can just have devastating consequences. The fact that you're sensitive to those issues and that you're pushing to de-stigmatize these conditions among the general public, but also health care professionals, is really going to be a valuable advance. Thank you for that sensitivity. Tom, what do you think? If you appear into the crystal ball? What does it look like? I would have to agree with Bob that we're going to have so many different medications that we will be able to combine together that we're going to see that it's more than possible to achieve weight losses of 25 to 30 percent of initial body weight. Which is just astonishing to think that pharmaceuticals will be able to achieve what you achieve now with bariatric surgery. I think that it's just, just an extraordinary development. Just so pleased to be able to participate in the development of these drugs at this stage of career. I still see a concern, though, about the stigmatization of weight loss medications. I think we're going to need an enormous dose of medical education to help doctors realize that obesity is a disease. It's a different disease than some of the illnesses that you treat because, yes, it is so influenced by the environment. And if we could change the environment, as you've argued so eloquently, we could control a lot of the cases of overweight and obesity. But we've been unable to control the environment. Now we're taking a course that we have medications to control it. And so, let's use those medications just as we use medications to treat diabetes. We could control diabetes if the food environment was better. A lot of medical education to get doctors on board to say, yes, this is a disease that deserves to be treated with medication they will share that with their patients. They will reassure their patients that the drugs are safe. And that they're going to be safe long term for you to take. And then I hope that society as a whole will pick up that message that, yes, obesity and overweight are diseases that deserve to be treated the same way we treat other chronic illnesses. That's a tall order, but I think we're moving in that direction. BIOS Robert Kushner is Professor of Medicine and Medical Education at Northwestern University Feinberg School of Medicine, and Director of the Center for Lifestyle Medicine in Chicago, IL, USA. After finishing a residency in Internal Medicine at Northwestern University, he went on to complete a post-graduate fellowship in Clinical Nutrition and earned a Master's degree in Clinical Nutrition and Nutritional Biology from the University of Chicago. Dr. Kushner is past-President of The Obesity Society (TOS), the American Society for Parenteral and Enteral Nutrition (ASPEN), the American Board of Physician Nutrition Specialists (ABPNS), past-Chair of the American Board of Obesity Medicine (ABOM), and Co-Editor of Current Obesity Reports. He was awarded the ‘2016 Clinician-of-the-Year Award' by The Obesity Society and John X. Thomas Best Teachers of Feinberg Award at Northwestern University Feinberg School of Medicine in 2017. Dr. Kushner has authored over 250 original articles, reviews, books and book chapters covering medical nutrition, medical nutrition education, and obesity, and is an internationally recognized expert on the care of patients who are overweight or obese. He is author/editor of multiple books including Dr. Kushner's Personality Type Diet (St. Martin's Griffin Press, 2003; iuniverse, 2008), Fitness Unleashed (Three Rivers Press, 2006), Counseling Overweight Adults: The Lifestyle Patterns Approach and Tool Kit (Academy of Nutrition and Dietetics, 2009) and editor of the American Medical Association's (AMA) Assessment and Management of Adult Obesity: A Primer for Physicians (2003). Current books include Practical Manual of Clinical Obesity (Wiley-Blackwell, 2013), Treatment of the Obese Patient, 2nd Edition (Springer, 2014), Nutrition and Bariatric Surgery (CRC Press, 2015), Lifestyle Medicine: A Manual for Clinical Practice (Springer, 2016), and Obesity Medicine, Medical Clinics of North America (Elsevier, 2018). He is author of the upcoming book, Six Factors to Fit: Weight Loss that Works for You! (Academy of Nutrition and Dietetics, December, 2019). Thomas A. Wadden is a clinical psychologist and educator who is known for his research on the treatment of obesity by methods that include lifestyle modification, pharmacotherapy, and bariatric surgery. He is the Albert J. Stunkard Professor of Psychology in Psychiatry at the Perelman School of Medicine at the University of Pennsylvania and former director of the university's Center for Weight and Eating Disorders. He also is visiting professor of psychology at Haverford College. Wadden has published more than 550 peer-reviewed scientific papers and abstracts, as well as 7 edited books. Over the course of his career, he has served on expert panels for the National Institutes of Health, the Federal Trade Commission, the Department of Veterans Affairs, and the U.S. House of Representatives. His research has been recognized by awards from several organizations including the Association for the Advancement of Behavior Therapy and The Obesity Society. Wadden is a fellow of the Academy of Behavioral Medicine Research, the College of Physicians of Philadelphia, the Obesity Society, and Society of Behavioral Medicine. In 2015, the Obesity Society created the Thomas A. Wadden Award for Distinguished Mentorship, recognizing his education of scientists and practitioners in the field of obesity.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The European Medicines Agency approved a kidney disease-related label expansion for Novo Nordisk's Ozempic, a GLP-1 drug, after a study showed a reduced risk of death by 20%. Keros suspended two arms of a hypertension study due to safety concerns, causing their stock to plummet. Pfizer's Ibrance showed improved survival in a new breast cancer indication, positioning it as a competitor to Novartis.Executives from Pfizer and Eli Lilly expressed optimism about collaborating with the incoming administration after dining with Trump. In other news, former Cytodyn officials were found guilty of securities fraud, Candel stock soared on promising phase III prostate cancer data, and several companies announced staff layoffs. Pharma M&A spending has been low this year, with only one deal exceeding $5 billion. These developments in the pharmaceutical industry highlight the importance of safety concerns and regulatory approvals in drug development. Stay tuned for more updates on the latest news in Pharma and Biotech.

Die Themen in den Wissensnachrichten: +++ Uno fordert Staaten zum Stopfen von Methanlecks in Industrie auf +++ Masern breiten sich stark aus +++ KI-Omi nervt Telefonbetrüger +++**********Weiterführende Quellen zu dieser Folge:Update ErdeMethane emissions tracking system proves its worth, but action to plug leaks must accelerate/ UN environment programm, 15.11.2024Measles/ WHO, 14.11.2024Phone network employs AI "grandmother" to waste scammers' time with meandering conversations/ Techspot, 14.11.2024Leqembi recommended for treatment of early Alzheimer's disease/ European Medicines Agency, 14.11.2024Alle Quellen findet ihr hier.**********Ihr könnt uns auch auf diesen Kanälen folgen: TikTok auf&ab , TikTok wie_geht und Instagram .

The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval of sales of lecanemab to treat Alzheimer's disease.

アルツハイマー病治療薬「レカネマブ」【ロンドン時事】欧州連合の欧州医薬品庁は１４日、日本の製薬大手エーザイと米医薬品大手バイオジェンが開発したアルツハイマー病治療薬「レカネマブ」について、医薬品を評価する委員会が条件付きでの販売を承認するよう勧告したと発表した。 The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval of sales of lecanemab to treat Alzheimer's disease.

Regina Demlová leads the CREATIC Center of Excellence, established in 2023 at the Faculty of Medicine, focused on rare undiagnosed diseases, high-risk pediatric tumors, and ATMP treatments for adult cancer patients. Jaroslav Štěrba heads the Department of Pediatric Oncology at the Faculty of Medicine and University Hospital Brno, serves as vice-dean, and is a member of the European Medicines Agency's Paediatric Committee. CZECRIN, the Czech Republic's key infrastructure for academic clinical research, connects national institutions to international clinical research through the European network ECRIN-ERIC.

Tumor infiltrating lymphocyte (TIL) therapy uses a person's own immune cells to fight advanced melanoma, offering new hope for patients who have limited treatment options. This week, we have a conversation with Brian Gastman, EVP of medical affairs at Iovance Biotherapeutics, about TILs and the company's pipeline.Iovance recently submitted a marketing authorization application to the European Medicines Agency for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. If approved, lifileucel will be the first and only approved therapy in this treatment setting in all European Union member states.The submission is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma.Iovance's Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication. 00:47-04:44: About Iovance Biotherapeutics04:44-07:57: What is polyclonal tumor infiltrating lymphocyte treatment?07:57-14:55: What is the production process for TILs?14:55-18:32: Are there any limiting factors for TIL treatment?18:32-20:59: Is early intervention important?20:59-21:22: Does better psychology help?21:22-22:06: Are other companies working on TILs?22:06-27:25: Clinical trials 27:25-29:25: How do you address cost?29:25-34:21: Iovance's pipeline34:21-35:30: Can TILs be improved?35:30-37:21: Where does the TIL space go from here?Interested in being a sponsor of an episode of our podcast? Discover how you can get involved here! Stay updated by subscribing to our newsletter

GET FREEZE DRIED BEEF HERE: https://wambeef.com/ Use Code WAMBEEF to save 25%! 10+ Year Shelf life & All Natural! GET HEIRLOOM SEEDS & NON GMO SURVIVAL FOOD HERE: https://heavensharvest.com/ USE Code WAM to save 5%! BUY GOLD HERE: https://firstnationalbullion.com/schedule-consult/ GET YOUR APRICOT SEEDS at the life-saving Richardson Nutritional Center HERE: https://rncstore.com/r?id=bg8qc1 Josh Sigurdson reports on the shocking details of European government statistics showing an incredible increase in excess deaths between week 21 of 2021 (the introduction of the Emergency Use Authorization of the Pfizer "covid" vaccine) and the fourth week of 2024. According to statistics, there was a negative rate of death for the first 21 weeks of 2021. Immediately after the EMA, deaths spiked to historic levels. The correlation is blatantly obvious. Children appear to have been most affected. The rate of excess death in children aged 0 to 14 years following week 21 of 2021 to the fourth week of 2024 was 335% or 42x according to the European Medicines Agency, looking at 26 European countries, NOT including Ukraine. We've already read hundreds of reports and studies on the effects of the so-called "covid vaccine" and the damage mRNA has done to tens of millions of people since the release of the deadly injections. From self assembling nano-particles to gene editing technology. From blood clots and myocarditis to turbo cancer and of course deadly auto-immune disorders. While people sit on their hands and fall for the latest plandemic hoax (bird flu, Monkeypox, Sloth Fever, Dengue, EEEV or whatever else they want you terrified of) we still have not seen justice for the mass murder of millions of people worldwide, especially children. The death rate actually sees an increase year over year despite people no longer getting covid injections on the regular due to a weakening body thanks to the mRNA injections. We will continue to see these numbers climb in the future unfortunately. We tried to warn people. The tragedy is also that this will likely be inter-generational. The children of those who've been injected are likely carrying severe future immune issues with them. Recently in Canada, 82 unvaccinated healthcare workers won an arbitration case against a hospital that fired them. The justice in minimal however and the fight to destroy the soul and consciousness of humanity continues in many different forms including new disease hoaxes in the path to the "Great Reset" and the tyrannical technocratic power shift we're entering into. Stay tuned for more from WAM! ORDER QUALITY MEAT TO YOUR DOOR HERE: https://wildpastures.com/promos/save-20-for-life/bonus15?oid=6&affid=321 Save 20% and get $15 off your FIRST order! Support your local farms and stay healthy! HELP SUPPORT US AS WE DOCUMENT HISTORY HERE: https://gogetfunding.com/help-wam-cover-history/ PayPal: ancientwonderstelevision@gmail.com FIND OUR CoinTree page here: https://cointr.ee/joshsigurdson JOIN US on SubscribeStar here: https://www.subscribestar.com/world-alternative-media For subscriber only content! Follow us on Twitter here: https://twitter.com/WorldAltMedia Pledge here! Just a dollar a month can help us alive! https://www.patreon.com/user?u=2652072&ty=h&u=2652072 BITCOIN ADDRESS: 18d1WEnYYhBRgZVbeyLr6UfiJhrQygcgNU World Alternative Media 2024

For decades, academic clinical trials consortia have collaborated to optimize outcomes for childhood cancers through evaluating incremental improvements in conventional multi modality treatment regimes. There are now increasing opportunities to partner with industry to test new medicines in academic-sponsored trials, but these collaborative studies rarely contribute to marketing authorizations. Under the auspices of the multistakeholder platform ACCELERATE, a working group of representatives was convened from clinical academia, the pharmaceutical industry, the European Medicines Agency, US Food and Drug Administration, and patient advocacy to explore why this is the case and to seek solutions to enable academic-sponsored trials to directly contribute to the licensing of new medicines. This presentation summarizes the group's findings and provides an industry perspective on how to move forward.Dr. Barry is a board-certified pediatrician and pediatric hematologist/oncologist with over 15 years of experience in drug development. Prior to joining Day One in 2021, she was the Global Clinical Lead for Pediatric Oncology at Pfizer, as well as Head of Pfizer's Pediatric Oncology Leadership Team where she oversaw more than 10 pediatric oncology clinical programs. She has also held previous roles at Genzyme and Millenium/Takeda focused on the development of oncology therapeutics in adults. Dr. Barry serves on the Industry Advisory Council for CureSearch and is a member of the ACCELERATE Platform Steering Committee. She is also a co-chair of the Children's Oncology Group Industry Relations Council. Dr. Barry is a graduate of the pediatric hematology/oncology fellowship program at the Dana Farber Cancer Institute and Children's Hospital Boston, and the pediatric residency program at Tufts. She received her M.D. at Yale University School of Medicine and also obtained a Masters in Medical Science degree from Harvard Medical School.

The world's first deaths from the mosquito-borne Oropouche virus have been recorded in Brazil. Two women have died from the illness in the state of Bahia in the northeast of the country.Claudia Hammond is joined by Dr Ayan Panja to discuss the implications of outbreaks of Oropouche across South and Central America.We also hear about the latest developments with Alzheimer's drug lecanemab as it's rejected for use by the EU's health regulator. The European Medicines Agency says the benefits of the drug don't counterbalance the risk of serious side effects, despite it being approved in the US earlier this year.Claudia and Ayan also look at both the psychology of languishing and whether loneliness leads to a higher risk of having a stroke.And we look at the research suggesting cycling to work can lead to an almost 50% lower risk of dying.Presenter: Claudia Hammond Producer: Dan Welsh

In today's episode, we cover some major stories in medical news:First up, the UK High Court has upheld a ban on puberty blockers for youth with gender dysphoria, citing a lack of evidence for their safety and effectiveness. While trans advocacy groups plan to appeal, the ruling limits use to clinical trials for now.Next, the European Medicines Agency has rejected a license for a promising new Alzheimer's drug called lacanumab over safety concerns, despite the drug showing ability to slow cognitive decline by 25% in trials. The setback is disappointing for many hoping for a treatment.Finally, an exciting development on the diagnostic front - a new blood test called AP's-2 has demonstrated over 90% accuracy in diagnosing early-stage Alzheimer's, outperforming primary care doctors. The test could revolutionize early detection if approved.

The European Medicines Agency has said that its committee for assessing medicines recommended "not granting a marketing authorization" to Alzheimer's drug lecanemab.

【ブリュッセル時事】欧州連合の欧州医薬品庁は２６日、日本の製薬大手エーザイと米医薬品大手バイオジェンが共同開発したアルツハイマー病治療薬「レカネマブ」について、医薬品を評価する委員会が販売を承認しないよう勧告したと発表した。 The European Medicines Agency has said that its committee for assessing medicines recommended "not granting a marketing authorization" to Alzheimer's drug lecanemab.

Dr. McCullough has made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), European Medicines Agency, and the U.S. Congressional Oversight Panel. Dr. McCullough begins the conversation with how Fauci lied to the people. The science they used was political science not peer reviewed science. The CDC,FDA and other lied about the vaccines, they do not work they actually make you sick. There are now more deaths from the vaccine then the covid. Disease X is already here, the [DS] already has vaccines standing by, but there are other cures that will protect you. 

BioSpace's Lori Ellis and Chantal Dresner are bringing live updates from #DIA2024 in San Diego this week where the first day kicked off with an inspiring story from Tom and Emily Whitehead of the Emily Whitehead Foundation, setting the tone for patient-centric discussions. The following panel featuring Emer Cooke, Chair, ICMRA an Executive Director, European Medicines Agency; Peter Marks, Director, CBER, FDA; Carsten Linnerman, CEO, Neogene Therapeutics, AstraZeneca Group; Dean Kamen, Founder, DEKA; and Stacy Hurt, Chief Patient Officer, Parexel emphasized the imperative of collaboration to improve outcomes, between regulatory bodies as well as with patients. Tune in this week to hear more from the event!

The World Health Organization recently authorized a second dengue vaccine. The move could provide protection for millions of people worldwide against the mosquito-borne disease. 世界卫生组织最近批准了第二种登革热疫苗。此举可以为全世界数百万人提供保护，使其免受蚊媒疾病的侵害。 This year, several dengue outbreaks have happened in places across the Americas. 今年，美洲各地爆发了多起登革热疫情。 In a statement on May 15, the U.N. health agency said it approved the dengue vaccine made by the Japanese drugmaker Takeda. 联合国卫生机构在5月15日的一份声明中表示，批准了日本制药商武田公司生产的登革热疫苗。 Takeda's dengue vaccine is known as Qdenga. It was previously approved by the European Medicines Agency in 2022. The two-dose vaccine is given three months apart. It protects against the four kinds of dengue. The WHO recommends its use in children between the ages of 6 and 16 who live in areas with high rates of dengue. 武田的登革热疫苗被称为 Qdenga。此前该疫苗已于 2022 年获得欧洲药品管理局批准。两剂疫苗间隔三个月接种。它可以预防四种登革热。世界卫生组织建议居住在登革热高发地区的 6 至 16 岁儿童使用该药物。 Approval by the WHO now means that donors and other U.N. agencies can purchase the vaccine for poorer countries. 世界卫生组织的批准现在意味着捐助者和其他联合国机构可以为较贫穷的国家购买疫苗。 Studies have shown Takeda's vaccine is about 84 percent effective in preventing people from being hospitalized and about 61 percent effective in stopping symptoms. 研究表明，武田的疫苗在预防人们住院方面的有效性约为 84%，在阻止症状方面的有效性约为 61%。 WHO's Rogerio Gaspar is director for the agency's approvals of medicines and vaccines. He said it was “an important step in the expansion of global access to dengue vaccines.” 世卫组织的罗杰里奥·加斯帕 (Rogerio Gaspar) 是该机构药品和疫苗审批主管。他表示，这是“扩大全球登革热疫苗获取范围的重要一步”。The first dengue vaccine that the WHO approved was made by the drugmaker Sanofi Pasteur. The vaccine was later found to increase the risk of severe dengue in people who had not been infected with the disease before. 世界卫生组织批准的第一种登革热疫苗是由制药商赛诺菲巴斯德生产的。后来发现该疫苗会增加以前未感染过这种疾病的人患严重登革热的风险。 There is no exact treatment for dengue. It is a leading cause of serious illness and death in about 120 Latin American and Asian countries. About 80 percent of infections are mild. But severe cases of dengue can lead to internal bleeding, organ failure, and death. 登革热没有确切的治疗方法。它是大约 120 个拉丁美洲和亚洲国家严重疾病和死亡的主要原因。大约 80% 的感染是轻微的。但严重的登革热病例会导致内出血、器官衰竭和死亡。 Last week, the WHO reported there were 6.7 million suspected cases of dengue in the Americas. That is an increase of 206 percent compared with the same period last year. In March of this year, officials in Rio de Janeiro declared a public health emergency over its dengue epidemic. Brazilian health officials began giving out the Takeda vaccine with the goal of protecting at least 3 million people. 上周，世界卫生组织报告美洲有 670 万疑似登革热病例。与去年同期相比增长了 206%。今年3月，里约热内卢官员宣布登革热疫情进入公共卫生紧急状态。巴西卫生官员开始分发武田疫苗，目标是保护至少 300 万人。 Infectious disease experts say climate change and the increased range of mosquitoes that carry dengue are partly to blame for the spread of the disease. 传染病专家表示，气候变化和携带登革热的蚊子数量的增加是造成这种疾病传播的部分原因。

We begin discussing the Indiana primary results and how GOP primary voters clearly are not inspired to act on their beliefs and change the party one iota. Perhaps, this is why we have not had a reckoning on the COVID genocide. I'm joined today by British investigative journalist Sonia Elijah, who gives a spellbinding presentation on how European countries continue to cover up vaccine injuries just like in the U.S. Some countries are criminalizing dissent and others are erasing excess death data points in order to cover the crimes. However, as Sonia observes, new data curated from the European Medicines Agency's own pharmacovigilance program shows a shocking number of heart attacks and cancers spiking in recent years. It also shows that COVID itself was the number-one side effect of the COVID vaccines! Despite this happening out in the open, and AstraZeneca even taking its shot off the market, there is no mainstream political party in any country that is not bought out by the industry. Therefore, not only have the perpetrators not been punished, they are taking the road show on to cancer treatment where they plan to do the same thing they did with COVID ... of course, after having caused a sickening amount of cancer from their deadly shots. Learn more about your ad choices. Visit megaphone.fm/adchoices

Joining us on the latest episode of The Law of Tech Podcast is doctoral researcher at KU Leuven CiTiP – imec and an External Collaborating Expert on Data Protection of Big Data and Real-World Data at the European Medicines Agency. As the concept of accuracy is gaining momentum in the context of data and AI regulation, Elisabetta takes us on a journey to better understand its practical meaning and identify existing gaps in its implementation in her domain of expertise: healthcare innovation.  Want to know more? Take a listen to the podcast episode on your podcast platform of preference!

Neurology Today Editor-in-Chief Joseph E. Safdieh, MD, FAAN, highlights new stories reporting on the impact of SARS-CoV2 on dopamine neurons, a European Medicines Agency warning about valproate risks for men, and neurologists on the pros and cons of working locum tenens.

In this eye-opening episode, Coach Vinny and Dr. Eryn takes you on a journey through the social media jungle, exposing the 5 RED FLAGS you need to make sure you look out for!Sponsored by LEGION Athletics, with a special offer for listeners (use code RUSSO for 20% off and double points on every order), this episode is packed with insights to keep you informed and empowered. Supplements without Supporting Research: Discover why blindly investing in supplements without proper research is a risky game. We share the loopholes in FDA regulations and the potential health risks associated with unverified ingredients. Learn the truth behind the quick fixes promised by many supplement enthusiasts. Fake Weight Loss Drugs and Compounded Medications: Unveil the dangers of fake GLP-1 medications and compounded drugs. We shed light on the deceptive practices of some pharmacies, emphasizing the importance of FDA-approved medications. Stay informed about the European Medicines Agency's warning and the risks associated with fake medications. Influencers Out of Their Lane: Get fired up as We tackle influencers spreading misinformation. From life insurance salesmen turned genetic testing promoters to nutrition coaches with limited expertise, learn to identify red flags and navigate through the sea of scientific jargon. Promotion of Peptides: Delve into the world of peptides like tesamorelin and BPC-157. We break down the challenges in ensuring quality and equivalence in peptide drug products. Uncover the potential risks associated with these compounds and why caution is crucial when considering their use. Weight Loss Challenges by Fitness Coaches: Rethink your approach to weight loss challenges. We expose the flaws in generic, one-size-fits-all protocols, urging you to prioritize sustainable, long-term habits over quick fixes. Learn why extreme dieting and excessive exercise can lead to metabolic suppression and rebounds. Equip yourself with the knowledge to navigate the fitness landscape and make informed choices. Tune in now and share this episode with your friends to spread awareness about the pitfalls of social media misinformation. Coach VinnyEmail: vinny@balancedbodies.ioInstagram: vinnyrusso_balancedbodiesFacebook: Vinny Russo Dr. ErynEmail: dr.eryn@balancedbodies.ioInstagram: dr.eryn_balancedbodiesFacebook: Eryn Stansfield LEGION 20% OFF CODEGo to https://legionathletics.com/ and use the code RUSSO for 20% off your order!

2024-01-05 Our hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Aditi Hazra with Harvard Medical School for a compelling discussion around implementing resilience framework in clinical trials.Several references were discussed during the episode from the FDA and EMA.1) FDA-2023-D-3550: “Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies”https://www.federalregister.gov/documents/2023/09/21/2023-20474/considerations-for-the-conduct-of-clinical-trials-of-medical-products-during-major-disruptions-due2) European Medicines Agency: https://www.ema.europa.eu/en/impact-war-ukraine-methodological-aspects-ongoing-clinical-trials-scientific-guidelineFollow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

In response to an EU investigation, The European Medicines Agency has admitted that COVID-19 vaccines were never authorized to stop transmission. Meanwhile, new studies show a link between masking and getting COVID-19 infections and adherence to lockdowns and an increase in mental health issues.

The weight loss market sees more ups and downs - Altimmune joins the fray and sees a stock jump while Pfizer experiences setbacks; and European Medicines Agency seeks additional information as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class. Meanwhile, AbbVie buys ImmunoGen for a cool $10B and scores a win with Teliso-V as ADC momentum continues to build. Plus, the FDA investigates malignacies linked to CAR-T. BioSpace's Lori Ellis, Greg Slabodkin and Tyler Patchen discuss.

Dr. Peter A. McCullough is board certified in internal medicine, cardiovascular diseases, and clinical lipidology. He cares for advanced patients with common medical problems including heart and kidney disease, lipid disorders, and diabetes. He has become an expert on COVID-19 and vaccine illnesses.After receiving a bachelor's degree from Baylor University, Dr. McCullough completed his medical degree as an Alpha Omega Alpha graduate from the University of Texas Southwestern Medical School. He went on to complete his internal medicine residency at the University of Washington, cardiology fellowship including service as Chief Fellow at William Beaumont Hospital, and master's degree in public health at the University of Michigan.Dr. McCullough has broadly published on a range of topics in medicine with > 1000 publications and > 660 citations in the National Library of Medicine. His works include the “Interface between Renal Disease and Cardiovascular Illness” in Braunwald's Heart Disease Textbook. Dr. McCullough has made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), and the European Medicines Agency. He has served as member or chair of data safety monitoring boards of dozens of randomized clinical trials.Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. He has >60 peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in The Hill. Dr. McCullough has testified multiple times in the US Senate and in several State Senate Committees concerning early ambulatory treatment of high-risk patients with COVID-19 and the safety and theoretic efficacy of COVID-19 vaccination. Dr. McCullough welcomes post-COVID-19 patients into his practice and will help them through the range of post-infection complications and injuries resulting from COVID-19 vaccination.BOARD CERTIFICATIONS:Cardiovascular DiseaseAdvanced LipidologyInternal Medicine

Christian Schneider is the Chief Medical Officer of Biopharma Excellence, and was formerly the Chief Scientific Officer at the UK's MHRA. He was the Medical Head for Licensing at the Danish Medicines Agency, and a member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. In this podcast, we discuss the continuing challenges to Europe's Biopharma competitiveness, and how an improved regulatory environment could be a benefit. Christian also highlights both the risks and opportunities of the EU's proposed revision of the general pharmaceutical legislation. This podcast was supported by The European Federation of Pharmaceutical Industries and Associations (EFPIA) and has been recorded in collaboration with PharmaLex GmbH.  It is not meant to serve as legal advice and may contain certain marketing statements. PharmaLex and its parent, Cencora, Inc. strongly encourage listeners to review all available information and to rely on their own experience and expertise in making decisions with regard to the information discussed today.   00:00:01 Introduction  00:01:05 What's your day like as a regulator?  00:09:48 Patient access to novel and effective treatments and patient engagement with the EMA.  00:11:40 Availability of data and clinical trials.  00:14:12 Clinical Trials Regulation.  00:15:19 Europe's loss of competitiveness and its role as an innovator.  00:16:36 The importance of Scientific Advice.  00:17:28 Revision of the EU Pharmaceutical legislation: Fostering innovation and streamlining the regulatory process.  00:20:32 Europe losing ground vis-à-vis the USA: Regulatory assessment.  00:27:37 The use of drug-device combinations.  00:32:30 Reimbursement and pricing decisions and criteria for (High) Unmet Medical Needs.  00:41:02 Revising EU Pharmaceutical legislation and creating a future-proof framework for clinical trials and R&D investments.  00:44:15 Ability of Member States to access all medicines.  00:46:27 Recommendations to the European Commission and the EMA on the EU Pharmaceutical package. See omnystudio.com/listener for privacy information.

Show Notes and Transcript Robert Malone's Substack has become essential reading for many of us.  Every day nuggets of wisdom and insight, information and humour drop into inboxes all over the world.  One of the recent emails caught our eye. What is Woke?  It's a word that we have come familiar with but many of us would struggle to define it.  It is an intolerant ideology that is sowing seeds of confusion and division.  Robert returns once again to Hearts of Oak to discuss what sparked the article and we have a close look at 15 examples of wokeness that he has referenced before we touch on another of his Substacks about 'Adulteration', which is a topic that we hope to come back to in more detail soon.  Robert W Malone MD, MS  Inventor of mRNA & DNA vaccines, RNA as a drug. Scientist, physician, writer, podcaster, commentator and advocate. Believer in our fundamental freedom of free speech. Connect with Dr Malone..... GETTR:          https://gettr.com/user/rwmalonemd X:                   https://twitter.com/RWMaloneMD?s=20 WEBSITE:      https://www.rwmalonemd.com/                        https://maloneinstitute.org/ SUBSTACK:   https://rwmalonemd.substack.com/ Interview recorded 26.10.23 *Special thanks to Bosch Fawstin for recording our intro/outro on this podcast. Check out his art https://theboschfawstinstore.blogspot.com/ and follow him on GETTR https://gettr.com/user/BoschFawstin and Twitter https://twitter.com/TheBoschFawstin?s=20  To sign up for our weekly email, find our social media, podcasts, video, livestreaming platforms and more... https://heartsofoak.org/connect/ Support Hearts of Oak by purchasing one of our fancy T-Shirts.... https://heartsofoak.org/shop/ Transcript (Hearts of Oak) Robert W. Malone, MD. It is wonderful to have you back. Thanks so much for joining us today, Robert. (Robert Malone MD) Peter, thanks for your friendship. It's been a pleasure to host you on the farm a couple of times and all of our many podcasts. I don't know how many we're up to right now, but I always enjoy talking to you and through your to your audience. So thanks for having me on again. No, thank you. And if what you're doing doesn't work out, if everyone deserts you on Substack, then I think you do have another future, which is steaks. I think that was the best steak I've had outside Texas. So I say, open up a steak restaurant, Robert. Yeah, that might be my future if the powers that be have their way with me. If you say too much, because that's just safer. But just for the viewers, @rwmallonemd on Twitter, on GETTR, anywhere else, And of course, Substack, rwmalonemd.substack.com. You just type in Substack, Robert Malone will come up. All the links are in the description. And that is also a way to support what Robert does in the many places he travels, speaks, interviews, and all of that. That is a one way of supporting him. or getting his book, which I had beside me, Lies My Government Told Me. There it is, Lies My Government Told Me. Make sure if you haven't got a copy of that, get a copy, it's a great Christmas present.  About to come out in Norwegian for all of your Norwegian listeners and in Dutch. I think we're gonna have the book launch in Norway in early December and the book launch in the Netherlands sometime in February. So stay tuned for that. And then we have another book that is just nearing completion on Cy-War and Sovereignty, which is the big propaganda, you know, there in the UK, you're certainly familiar with nudge technology and the 77th Brigade and MI6 and all of their various nefarious activities through the COVID crisis. Oh, yeah. I look forward to that coming out. The Norwegian languages, maybe I'll give it a miss. So I'll wait for the new book.  We've got a great cover. I look forward to it. Robert, I love your Substack. There may be four different sub-stacks that I follow because you can have an avalanche of information and yours is one of those. And my favorite thing is you don't know what you're going to get. Each day is different. It could be on the farm, it could be travel, it could be latest scientific research coming out, it could be government agencies and how they work. And I love that huge mix and that wide array. And one of the recent ones just days ago was, what is woke and intolerant and moralizing ideology? And you had a little cartoon at the beginning and at the end, the definition was stuff I don't like, which I actually thought was a good definition. But it's a term that I think we now use frequently and we kind of know how to describe things as woke, but we're not very sure what exactly that is. If we see something, oh, that's woke, why? The definition of pornography, I can't define it but I know it when I see it. Same with woke. And yeah, so thanks. This was almost kind of a throwaway Substack, that Jill put together on the fly. Basically, we tend to wake up in the morning or as we're going to sleep the night before. This is our lives. Hey, welcome to our lives. We lay in bed and talk between the two of us. Well, when are we gonna write tomorrow? I don't know. Good heavens. And so, in this case, what transpired was we, when we like to turn off our brains, we turn to the, you know, streaming. We never watch television per se, but we stream. And they tend to fall into two categories, basically, science fiction and documentaries about history or travel. That's kind of our lives. I know it's pretty exciting. And so we were watching this new Netflix series called Bodies. And it proceeds because it's a kind of a multi-timeline thing that is all wrapped around the UK and London is the setting for the series. And I don't want to go into the plot line, but basically, in episode three, suddenly we have the insertion of this gratuitous, let's say, gently man love, with a fairly explicit scenery associated with it. And it was absolutely gratuitous, not necessary for the plot line. It was clearly another woke agenda insertion, as we have come to expect from Netflix routinely. And this one was so in your face that we just, both of us, looked at each other and flipped off the TV. Okay, enough of that. Time to go to bed. And then Jill, in the morning, woke up and she said, I've got to find some way to be able to pre-screen, these various streaming broadcasts for their woke content. I wonder if there's anything out there on the internet. And so she started searching, and she found this delicious site that is mentioned in the article. Notwokeshows.com, which I've delved into.  Yeah, so she finds notwokeshows.com, and she's like, hallelujah, this is a goldmine, because they have listed all these criteria that they apply to define whether or not a show is woke, and whether or not they're going to include it in their recommended broadcast that one who is, let's say, not enjoying the woke agenda can safely view. I guess this is akin to the censorship board there that the BBC sponsors for you lucky members of the United Kingdom. And so you're all so fortunate that the government looks out for you so carefully and maintains your mental health in alignment with their interests. So in any case, she finds this website and it's such a rich repository of, you know, a little bit tongue in cheek, but on point. Commentary about what constitutes woke from the perspective of some group that is seeking to delineate woke from non-woke, broadcasting and being able to to list, non-woke content, that she writes to the authors and they write back and because we've become quite sensitized to issues concerning copyright. And so they write back and they say, yes, absolutely. You're free to use this. We're so grateful and all happy, happy. And so she takes basically their content and disambiguates or redacts it or restructures it so that it's not specifically about programming, but speaking more directly about what is WOKE and from the framework of these individuals that put together this website that previously has been relatively unknown and blasted out together with the crosslink to the source material, et cetera. And that's what gives rise to this fun little throwaway essay, which was her basically, uh-oh, we've got to get something out this morning. How about if we do this? while I happen to be writing an in-depth technical piece about adulteration and the RNA vaccines, which was going to take much longer. So we wanted to get something out to our Substack subscribers so they have it with their morning coffee. And that's the genesis of this particular essay.  And I will finish on adulteration, another word that we've come across only in the last few days. But I love this article simply because it's what people are facing, the people are, and what you described is exactly what millions and millions of people across any country face. You look at something and you're not sure where to watch it and you're not sure what the plot line will be and often it... I've watched different shows and they start off one way, being macho with a hero, like all 24 type. And then by the end, it's something completely different. They slipped it in.  They've really gotten quite clever about it in advancing this agenda of a particular way of looking at the world. And of course, the UK has been one of the world leaders in advancing nudge technology, which is what this really is, that we're encountering in broadcast media, is applied nudge. And, you know, this is another case of a slippery slope. Who's against reducing public tobacco consumption? Oh, you know, we're all for that. We don't want passive smoke. And well then, so then it's okay to use nudge to reduce that. And then, well, who's not in favour of more tolerance against ethnic minorities? Well, of course we all want that. Well, how are we gonna do it? Well, we'll take this same nudge technology and apply it like a great big hammer to that one. And so then we, I'm gonna, this is a sacred cow. So then we have the infamous Dr. Who has suddenly become a femme, et cetera. And that kind of went over like a lead balloon, as I recall. But it doesn't matter. In pursuit of the social engineering agenda, profitability and audience uptake and acceptance are totally secondary to the broader mission of advancing social equity as defined by whomever they are that established all these agendas and try to propagate it globally. Another one that I ran into recently was a CNN broadcast looking at travel and food in Italy. Who isn't interested in Italian food and travel? I mean, that's a great topic. And this is coming off of Anthony Bourdain's suicide and how successful his series was, because I think CNN is trying to pick up the ball. And so they get another actor, a well-known Italian, I'm not gonna beat him up, that tours Italy. And we're in about three episodes and suddenly we're getting propagandized about, in favour of basically Italian socialism, and the importance of accepting immigrants from North Africa and integrating them into Italian society and that these far right people, or go Giorgio Moloney, et cetera. Because anybody who is against immigration is obviously far right by definition. And Mussolini is just right there. Don't like immigration, you're one step away from full-on Mussolini fascism. And so that's how that particular series has gone. As another example is that it's become a platform for advancing these same social theories, ostensibly under the guise of a travel show focused on Italian cuisine. I mean, it pervades everything. It does, and I know that you give 15 examples. You go through, of course, The one that stands out, which you've also known for the last three years is called COVID-19 virtue signalling. Virtue signalling is a term that links with woke. But that maybe took it to a new level of advisories, COVID advisories under videos, giving you the different side. And Andrew Bridgen speaking in the House of Commons, whenever he was talking about vaccine injuries, at the bottom, it kept bringing up all these piece of information of why, what he was saying was rubbish. But even on the COVID stuff, the mask, the double, the triple masking, or people getting a sticker to say they've had a jab, it was in your face, in public, I guess, in a way that we hadn't seen before. And the social distancing, I mean, all these things had no, even though they were cloaked in scientism. Which is, you know, we've got to be careful about using that term, Jill constantly reminds me, because it is actually formally defined as, the belief system around everything that is true and real can be directly perceived and detected. So that's the essence of scientism. And in definition, it's in opposition to, let's say mysticism at one parameter and belief in theology and religion in another parameter, or we could talk about the ancient Celtic religions of paganism, for instance, all of that being in opposition to this belief that only things that we can measure and detect are true. But the term scientism has been kind of transformed a little bit with Dr. Fauci being the poster child of scientific truth is that which is asserted by largely the government and government agents that their interpretation of scientific truth is the one and only truth and there shall be no debate. And the BBC and the Trusted News Initiative have become the guarantors and the enforcers, of that logic that the only scientific truth, quote-unquote, in this post-truth, post-modern world is that which is advanced in the approved narrative endorsed by the government. And you start off, right at the beginning, it is alphabetical, but the 15th, you talk about anti-religious bias, and I'm shocked at how we see that so prevalent, that those with a belief system, and often a belief system in Christianity, are hateful or certainly hypocritical or, I mean, the level of vitriol that is attached to someone who believes something and I guess the whole issue of belief of absolutes is completely alien to a woke agenda where anything goes and truth is subjective and that level of mocking and ridiculing is dangerous certainly in a country as in yours based on biblical foundations and Christian truths and yet now we are encouraged to attack the very foundations on which our societies were based on. Right, and this is all rife with paradox. So you point out that Christianity, and in particular, traditional Christianity, and in most particular, this new insurgent movement within the Catholic Church in opposition to the Pope called Trad-Cath, those folks are in particular demonized for the sin of wanting to receive the liturgy in Latin. You can't make this up. It's so intrinsically absurd. And the bizarre paradox is that, in parallel, the prior religious orientation that was so heavily weaponized, that being radical Islam and Islam, you know, generalized Islam suddenly is aligned, in a paradoxical way with the woke slash progressive or approved agenda, in this enormous rift that has occurred in the context of, let's say gently, the IDF Gaza conflict. And I absolutely don't want to go there because I find that information landscape to be so heavily contaminated with very advanced Psy-War capabilities on both sides that once again this is absolutely a post-truth, post-modern battleground of two highly developed Psy-War capabilities going head-to-head on the world stage in which we could debate who are the victims and who are the perpetrators here, but I think truth is absolutely on the victim list. It's become completely subjective, and that's what's happened throughout all of this, is, as I keep saying, this is postmodernism, in which truth is a subjective quality that is, not intrinsic, but rather is subjective and is the product of exertion of force and capabilities in the information landscape, and is defined by those who are able to dominate that information landscape. Truth is entirely subjective and is a function of whoever is the dominant party in what I call this post-modern golden rule, those with the gold make the rules. And it's now those with the gold define truth. It's so true. We've just had today, there was Rishi Sunak, sadly, our Prime Minister here in the UK, little in substance, little in size, little in vision, but Rishi Sunak-  Well, now don't be staturist. But Rishi Sunak, he was talking about a new AI Institute, which the UK is setting up, and it's going to be the world's first AI Safety Institute. And he talked about, we want to have a AI consensus on what's good and bad, just like we have a climate change census. Right, so AI has been sold to the public as a neutral arbiter of truth, but we know from the various AI applications and algorithms that are available now. That AI and machine learning and deep learning are very much a consequence, a derivative, of the source information that is used to build those algorithms, that train them. And so by selecting the information, so for instance, it's just like Wikipedia. Wikipedia defines truth as basically the work product of corporate media, which is to say the Trusted News Initiative. So if it's endorsed by TNI, then it must be true. And that is what comes out in those. So it's not even, it's beyond scientific papers. It's whatever large corporate media puts out with their spin becomes the only allowed input vector for Wikipedia. And this is done, you know, when we now know that Wikipedia is being edited in real time algorithmically by our intelligence community, including your lovely MI6. And so it, you know, people still perceive wiki as a source of basically akin to the Encyclopaedia Britannica, but it's absolutely not. Now, I haven't dove into how badly Encyclopaedia Britannica is being manipulated. I don't know the answer to that now. But the AI-based engines have absolutely been shown to have political biases that are, you know, apparently derived from their training source material. And so, for instance, the other day, Steve Kirsch gave an inquiry to one of them, that I was not familiar with previously and asked if anybody, that had been a anti-vaxxer had turned to being in favour of the vaccines. And he was very comforted by the fact that he was not so identified. But myself and Jessica Rose, and there was another person, were identified as having previously been anti-vaxxers. I'm the vaccine developer anti-vaxxer who invented RNA vaccine technology. That, you know, you have to, this is for, you know, park your cognitive dissonance is irrelevant. But then had now strongly endorsed the COVID vaccines, and indicated that everybody should get them. Absolute lie, absolute propaganda, none of that true that was listed, but that's what spat out in response to that question. And with Jessica Rose, it asserted that she was a former beauty queen. I've never heard her talk about that before. I got to ask her about whether or not she was once a beauty queen. And also went into the same kind of a flip-flop, which I know has not happened. So it's, those of us, and this is another part of my background that most people are unaware. For the first two years of my undergraduate, I was a computer science student and actually took top honours for that time. I just didn't wanna spend the rest of my life in a basement looking at a CRT tube. I was taught early on, garbage in, garbage out. With any program-based algorithm that abstracts from data, your source data will determine the product. You can have the most sophisticated deep learning algorithm, but if it is employing a biased data set, it will give you a biased answer. And that's absolutely what's happening, but it's being pitched to the public as if this is a godlike, neutral arbiter of truth, and it is so easily manipulated. The question is, is Rishi in the cohort of... I don't really understand the technology, but it seems awfully cool. And this tension always exists between nefarious intent and incompetence. And is he merely an incompetent or is he aware of how readily artificial intelligence algorithms can be manipulated? I don't know the answer to that. The dangerous thing is, I think he is aware, because I think his wife's family made the money off tech industry, partially through tech, so he should be aware of it. Exactly. He should be a sophisticated user, and then the derivative of that would be, this is not a guy that can be trusted because he's misrepresenting truth to the British public. I know that you would probably be shocked and we will probably be de-platformed and severely, maybe I better be careful because I want to fly back into London to help out Andrew on December 4th, so I don't want to get arrested when I land at Heathrow. Well, we'll see how that happens. You may just stay in the UK for a while and that will keep you. Government hospitality. You started by talking about that Netflix series, the slipping in of man love, as you said, and I've been watching another BBC programme and three series in, oh, suddenly now there's the other side, woman love and that slipped in, doesn't fit with the story, doesn't add to it at all. But in your article, you talk about bad masculinity and where male behaviour is inherently toxic and negative. But then again, the fun side, because you have to sit back and with a smile and begin to mock the chaos and confusion and people trying to jump through hoops and put these together. You've got the whole infinite genders and how that works. And I was sitting watching GB News yesterday and they had someone on who I think was, I'm not sure whether male or female, a strange hybrid. They were talking about-  What's wrong with you? It's irrelevant. I no longer know what it means a trans woman. A trans woman, I think, okay, just go back to basics. How did the person start? That's where I need to start with. But this confusion, if male psychic or identification is toxic, then what happens if a woman then decides she's a man, is that then still toxic or is that now acceptable? And this chaos and confusion. Yes. Oh, like I said, the cognitive dissonance associated with this, which has no well-structured underlying logic, is profound. And so you have, like with any cognitive dissonance, you have to just park that, don't confront it, because it will drive you mad. It's, cognitive dissonance is one of the major sources of psychological pain, and, but only if you confront it. And so for your mental health, you should, Peter, you should really need to stop thinking about things like that. And, go back and and reread 1984, but consider it to be a guidance document rather than a warning document, and it will all be fine. Along those lines, I strongly, in terms of content to consider in streaming, often overlooked is this lovely little sci-fi piece with Uma Thurman, as I recall, called Gattaca. And I strongly recommend, GATTAGA is actually intended to be a DNA sequence in this particular sci-fi piece, which is very well-produced, way ahead of its time, and absolutely predicts the almost as prescient as 1984 was, absolutely predicts this new reality, postmodern reality, that we're walking into, where your genetics define, who you are and what you're allowed to be on behalf of government industry and everything else. So that absolutely should be on everybody's watch list if you haven't already seen Gattaca. But this logic that you're talking about, toxic masculinity of course, is what Jordan Peterson, has been so reviled for speaking against. And of course we all know that Jordan Peterson is now, subject to re-education by edict of his local health authority, I think in Toronto, as I recall. And they are also subjecting other physicians to what re-education processes that have had, you know, sinned by prescribing ivermectin or hydroxychloroquine for early treatment and written statements recommending that individuals should not, they should not necessarily be required to take the mRNA vaccine products or other genetic vaccine products, which the government so heavily advocates. And in those re-education processes, which the individuals are required to pay for, by the way, the state doesn't pay for that re-education. it's like three to 5,000 bucks. And at the end of which you have to write a letter demonstrating that you have successfully incorporated the teaching of the re-education process and that you are sufficiently contrite for your past sins. And if you do not show sufficient contrition in this letter, I mean, this is full on Soviet, right? If you don't show sufficient contrition, Then you will have to pay for another round of re-education ad nauseum until the overseers believe, they become convinced, that you have provided the necessary written, signed documentation that demonstrates that you are requesting humbly forgiveness for your sins, and that you have indicated clearly in this public document that you will not sin again. And so anybody that asserts that this is not actually a false religion isn't paying attention, because that's what we have, this, whatever you want to call it, wokeism or whatever, this new censorship, industrial complex, propaganda infrastructure that so much of it traces back to UK social science, I'm sorry to say, is now enforcing itself on the population using the classic totalitarian methodology. And I'm reminded, someone pointed out to me the other day when I was at Shannon Joy's event in Rochester, that Mattias Desmet, when he speaks of totalitarianism, he's not, a key differentiator between authoritarianism and totalitarianism is that authoritarianism under a dictatorship or other structure is a minority imposing its will on the population. Totalitarianism, it is the totality of society that is acting in this way. It is a social consensus, in this case a manufactured one, but it is a social consensus that this is the way we shall be. And one of the key factors in when totalitarianism emerges in a society and basically integrates itself into the entire system is that you can turn over the leadership, ergo Rishi and the prior prime minister that you guys, that brief stint that you all experienced. Forty-five days. You can replace the leadership, and it will not change the process until the entire population wakes up from what's happening. Because there will be new leaders emerge organically from the society to fill that role of dear leader. Because this is absolutely a function of a deep psychological process that is consumed the society. So we can all in our little bubble of resistance cell, Is it 20% of people? Is it 5%? We can go back and forth. We can all laugh at the sheep and what's going on and point out their logical inconsistencies. It's irrelevant until such point as people literally wake up and recognize that this is, at a minimum, not meeting their needs. You know, this is the classic question, are you better off than you were earlier on under this, I guess it's conservative government that you have that is not acting very conservative?  Yeah. are you better off now than you were then? And at some point the culture says, no, we need a change. And they collectively wake up, but when that's gonna be, is it gonna be next year? Is it gonna be next decade? Or is it gonna be 100 years from now? There's no way to predict. Yeah, I'm just imagining, sorry, I'm just imagining Jordan Peterson writing a letter of apology to the Canadian government saying how wrong he was. I think this actually could be a series, you could have different, I'm sure you would love to do one program, you know, many people, a whole 45-minute fly on the wall, high-profile individuals writing I'm so sorry letters, sounds perfect.  Yeah, I think Babylon Bee needs to take this up immediately. Hey, there's one more.  Russell Brand ought to do this. This is absolutely made for Russell Brand. I think you need to patent this idea immediately.  Russell Brand's an intriguing character. I'm not going to go there. One other thing I'd pull out, distorted racism, and this pitting people against others. Living in London, being in a very mixed culture, coming from Northern Ireland, being in a mono culture, and enjoying that mix and all that brings, and then this push to, no, you must see racism behind everything. That on top of everything else, it is, the tension that is developing in society is frightening. The people are encouraged to pit themselves against someone else instead of agreeing to disagree, not allowed to agree to disagree. And if you don't agree, you're wrong, you must be hated, you must be mocked, you must be attacked. You see as well in the States that that tension is bubbling under the surface. And it's just, I mean, we're laughing at our Canadian colleagues, but we know that they have been at the tip of the spear in advancing a lot of these agendas, most notably the de-banking, is the most egregious example. And Nigel can, there in the UK, can speak eloquently at length about the debanking agenda and its intended linkage with social credit system. Yeah, so the question is, I think for all of us, again, this grappling with the tension between incompetence and nefarious intent, which is so hard to disambiguate unless we're mind readers or we are able to get through Freedom of Information Act, the smoking gun documents that establish nefarious intent. But this division of society, again and again and again, repeated division into subgroups on top of subgroups on top of subgroups, absolutely has the appearance of serving the interests of large financial and power interests, which may be transnational, multinational, or globalist. We have these euphemisms that are all used. Just as the hypothetical, not saying necessarily this is what's happening, but if you had, let's say, traditional monarchists or large banking conglomerates. Or we can go down the list of potential actors that were interested in further enhancing their power and financial base at the expense of what ostensibly is a self-governing populace, then I hesitate to use the term democracy. And I would get attacked if I used the term democracy in the United States, because we don't technically have a democracy, just like technically you don't have a constitution. But it certainly has appeared to be in the interests of these very large concentrated power blocks that are led by a very small number of individuals who happen to be, have accumulated, you know, calling it wealth is kind of almost a misnomer, assets in power that they have, they and their families or progenitors or associates have historically exploited to further concentrate and exert their influence over world affairs. That's my attempt to be politically correct and wrap things with words that the average person would just say, well, they're all corrupt and they want to run the world. And as I get, again, I cite back the postmodern golden rule, those of us of a certain age recall when the golden rule was due unto others as you would have them do unto you. And in the postmodern world, the golden rule is those with the gold make the rules. Maybe it's always been that way. I don't know. Maybe I was just naïve back then when I was listening to my pastor speak on the lectern in the Episcopalian church that my parents used to go to. And that's another thing that I find fascinating When you think about it, we all, many people used to... I'll say, make fun of the Church of England in its leadership in advancing what we now recognize as a woke agenda. But it is increasingly normalized across much of the Christian theologic space, notably including the Catholic Church, the current pope. So maybe we got it all wrong. Maybe the Episcopalians were actually the tip of the spear in advancing the new world order. I don't know. But it kind of increasingly looks that way. One would never imagine the Episcopalian clergy as, I don't think any stereotype would label them as the avant garde cutting edge of social change. And yet, so it would seem.  Yeah, that fight for truth in the church, whenever it's there in black and white in the Bible. Can we finish on, word of the week, adulteration, this, I guess,  Great memes circulating, with, I guess the Sermon on the Mount with the stone tablets, with the 10 commandments and the statement, thou shalt not commit adulteration. And no, it's not adultery. Yeah, so this is a scientific technical term and a regulatory term. It's actually entrenched in American federal law and throughout the world in regulatory statutes, and policies that have largely been enforced and structured, through the International Committee on Harmonization, throwing out some buzzwords there for all of you wokes, which is kind of the international body that has harmonized it. You know, that's another good woke term, very important in European politics. We all want to be harmonized and aligned. But harmonized regulatory policies globally, so that Mr. Pharma doesn't have the inconvenience of having to restructure their regulatory documents for each nation state that they submitted to. So harmonization is important, and a key term throughout all of this is adulteration, which is in its simplest form. It is the incorporation of adulterants or impure material into, in the original American statute, food, devices, or drugs. Remember, we have the Food and Drug Administration that's responsible for this. And it goes back to the time of the scandals that Upton Sinclair revealed in his classic works, literary works, concerning the Chicago slaughterhouse environment and contamination of food with rat faeces and other materials. So rat faeces or other awful, you know, excrement from animal species contaminating foodstuffs is absolutely considered to be an adulterant. But technically in the drug space, adulteration consists of inclusion of materials in a final drug product, that are not specifically disclosed in the label. Remember the label also includes that little package insert that goes in the box that says all those things that nobody ever reads in the very fine print. But basically, as one is allowed to market a drug product, typically that requires the final drug product, I'll say this way, is defined as the sum total of everything that goes into making it. So the manufacturing process, the testing and release, the regulatory documentation, the documentation about the clinical trials, all of that, it's not just the stuff that's in the pill or in the syringe, but it's all that stuff, that documentation and information that surrounds it, that cloud of information. And so technically, if a regulatory authority together with a manufacturer disclose that, well, In fact, in our product, there is a certain fraction of rat feces, but we have a test for rat feces, and those rat feces cannot exceed 0.001% or whatever the thing is. That type of thing makes that not an adulterant. If it is disclosed and you have some parameters around it, then that's acceptable. What's happened here with these RNA genetic products is that two things have not been disclosed. And basically, they have been detected, by two different laboratory groups, one in the United States and one in the University of Guelph. You'll remember University of Guelph being the home of Byron Bridle. And so now we have another Guelph dissenter, solid, rock-solid scientist in his group that does DNA sequencing that these two groups have acquired at great difficulty because, of course, this is forbidden in most nation states to be able to analyze the vials that Pfizer or Moderna give us. We're told to just accept them that they are as they are asserted to be, which has never been the case with other drugs. Always a national authority like Paul Ehrlich or the European Union will independently verify that what is in the vial by random sampling is in fact what pharma says is in the vial. And it's within those limitation parameters that are predefined in the regulatory package. But it turns out that they were asleep at the switch or wilfully ignorant or we can extend that out, and hopefully someday we'll have the documentation to allow us to discern how the heck this happened. But we are hearing now more and more a cascade of mea culpa statements, from European Medicines Agency, Health Canada, Australian regulatory authorities, yet to hear this from the FDA for some reason, that in fact, we're guilty. We weren't aware. Mr. Pharma misled us.  Pfizer, Moderna, whomever, misled us. And in fact, there is quite a bit of these small linear DNA fragments contaminating the final drug product. And by the way, the DNA source, a circular piece of DNA that was used to manufacture the RNA, it was grown in bacteria. And that leads to another whole can of worms is the endotoxin contamination. And whether it's been adequately monitored. Endotoxin being something that's known to cause shock in humans when injected, humans turn out to be exquisitely sensitive to injected endotoxin compared to many other species. And that may have something to do with some of the anaphylactic reactions that patients develop within the first 24 to 48 hours. Certainly that is consistent with endotoxin contamination. but also that we have this DNA contamination. And so, because it wasn't disclosed. And furthermore, the composition sequence of the plasmid from which these short DNA fragments are derived was not disclosed. And in particular, the existence of some sequences derived from simian virus 40 were not disclosed. And a lot of then this constitutes an indulgent. And the EMA and some of these other health agencies are now basically saying, not our fault, Pfizer didn't tell us about it. And Pfizer is coming out with statements saying, well, we didn't tell you about it because we didn't think it was important. I'm paraphrasing, but that's the essence of the argument. And it turns out this is not okay, because short linear DNA fragments that are produced by degrading these plasmids are among the most highly active DNA molecules if you want to mutate a genome, let's say, of a cell line or an experimental animal. And normally, that level of DNA contamination would be below the threshold that has historically been imposed for vaccines. So it's a chronic problem, DNA contamination in vaccines. Basically, it was a major reason why the Solvay program that I was on got killed, because they couldn't get rid of all the DNA they needed to from the cell lines that were growing the flu. That's a tangent. But it's a known problem in biologics manufacturing. And so technically, the threshold level of DNA fragments that are there are below the historic allowed DNA contamination. But it's kind of apples and oranges because with an injectable, let's say, a flu vaccine, it's not designed to be a polynucleotide delivery system. Okay, but what we have here with these RNA products, thanks to the enabling technology created at the University of British Columbia by Peter Cullis and his colleagues after decades of work, by the way, they were the ones, if anybody's going to get the Nobel Prize for the enabling technology advance, it was those guys, not the pseudouridine people, but that's another tangent. So shout out to Peter Cullis, I guess, for enabling this technology in vivo. But that tech is agnostic about whether it's DNA or RNA. And so you have the most potent non-viral delivery system ever devised by man being formulated with not only RNA, in RNA that isn't really natural RNA, it has a very, very long half-life and it's immunosuppressive if that was by design, but also with these short DNA fragments, which are known to be highly mutagenic. It hasn't been proven in these formulations, but the literature is explicit on that and abundant, that short linear DNA fragments will drive mutations in your cells in your body, if it's injected through your body. And then perhaps most worrisome, we know that these formulations, based on the Pfizer common technical document that was submitted, that's the non-clinical package to get authorization to proceed. That was kind of the last shot at doing the real toxicology, revealed that these particles have a surprisingly high affinity for ovarian tissue. Which is where germ cells reside in the form of eggs, ova, and not tested was whether or not these ova take up these particles, but certainly the ovarian tissue in general does. And then of course, we also have the recommendation that pregnant women should be receiving these products. And we know from the literature that these products cross the placenta. So they are getting into baby, and baby is in first trimester in a highly, rapidly developing embryonic environment. And so my determination is this is a true risk. It is one that will manifest in the form of somatic cell cancers, particularly lymphomas and leukaemia's, which by the way, we do happen to be seeing a surgeon inexplicably. But if you wanted to, in an experimental model, drive the development of leukaemia's and lymphomas, you could use retroviral gene therapy vectors. That's why it basically killed retroviral gene therapy was because of these side effects of leukaemia's and lymphomas because of insertional immunogenesis. And you could do it experimentally if you wanted to discover oncogenes or tumour suppressor genes, because that's how this technology was used. You could deliver, using these cool new formulations from Cullis et al, short DNA fragments, and they would absolutely disrupt the genome. And so there's the cancer risk, and there's obviously a germline foetal development mutagenesis risk. And I'm confident enough, because this was the area of molecular biology that I literally cut my teeth on originally. Mouse memory tumour virus, intentional mutagenesis, and searchable mutagenesis in order to search for oncogenes and tumour suppressor genes, under the mentorship of MD, PhD pathologist, one of the first molecular pathologists who had just finished a sabbatical with Bishop Envarmus, who got the Nobel prize for discovering oncogenes. Okay, so I know this area, the literature is clear and explicit, and I'm so confident about these observations that I'm willing to put my reputation on the line and say, this is happening at some frequency. We just don't know what the frequency is right now. Well, it's a huge topic and it's a perfect end. And I know another reason to get your Substack is you've just put an article up on this, republished a trial site news piece on this and people can delve into that. But Robert, I always appreciate your time for coming on and congratulations on having a speaker in the house. Now the Republicans can continue to use their majority for to do nothing. So well done. Oh what a bizarre world we live in. So yes, all true. I'm from Louisiana and we now have a Republican governor in Louisiana who I've known and worked with. It's been my pleasure. And the new speaker talks the talk, so let's see if he'll be able to walk the walk about all these various issues. And time will tell on that, but they are under a pretty short deadline to fund the government. And are we going to continue to see basically kick the can down the road, continuing resolution, or are we going to see the Republican marginal Republican majority in the House that ostensibly is the ones that are supposed to create the budget actually do what they have been saying they're going to do and take up all these independent budgets for funding the various public agencies, including Department of Defense Homeland Security with CISA, the intelligence community and their black budget, and all of these other weird and wonderful agencies that we have developed here in the United States that are bleeding us all dry and driving... The other day, I was reading Doug Casey's International Man, and he used the metaphor that the American government is like Wile E. Coyote in the Roadrunner series. It's already run off the edge of the cliff and it just isn't aware that it's about to plummet down to the bottom and get crushed. We are way past the danger zone in terms of our indebtedness. I don't know what's gonna happen.  100%. For the viewers and for listeners, make sure and follow Robert if you don't already on his Twitter or on GETTR, on the Substack, and lies my government told me, is a perfect Christmas present gift. So do look out for that. Do get a... Oh yeah, please.  A copy. And pass out, but-  I've heard it referred to as an important historic document. Oh, it is. Oh, it is.  Because it was written in real time. And that could never be written today because many of the references have been getting scrubbed from the internet. Yeah. Yeah, we've seen that. Absolutely. Robert, thanks so much for coming on, sharing your latest Substack and a number of other thoughts. So thank you. Thanks, Peter. Anytime.

In this Best-Of edition of the Vital Health Podcast, we're looking back on the outbreak of the COVID-19 pandemic and discussions we had with statistician Miriam Sturkenboom and Ivor Cummings, both of whom, in very different ways, were at the center of COVID-19 as to the appropriate response to the pandemic. Miriam Sturkenboom, who's vaccine safety monitoring platform VAC4EU, found herself at the center of a tsunami of vaccine rollouts and safety studies in Europe, providing evidence to the European Medicines Agency and other public health bodies. This podcast was first broadcast in October of 2021. Now an internet and social media legend, it's likely you've stumbled onto Ivor Cummins dissecting the impact of the response to the pandemic with detailed graphs and analysis on YouTube or X (f/k/a Twitter). Before the COVID-19 era, Ivor was a biochemical engineer and had a large following as a presenter on cardiovascular disease, diabetes, and obesity on his popular website, ‘The Fat Emperor.' The interview with Ivor was first broadcast in February of 2021.See omnystudio.com/listener for privacy information.

Up to 80% of people with schizophrenia aren't aware they're experiencing early schizophrenia symptoms. Most people with schizophrenia go through a prodromal stage, where there's subtle changes in mood, thinking, and behavior. It's an evolution of the symptoms to come. Early indicators vary based on the age they start. An adult who develops schizophrenia will experience different signs than a child who develops the condition. Host Rachel Star Withers and cohost Gabe Howard explore the early signs of schizophrenia in children, teens, and adults. Joining to discuss the future of identifying biomarkers for schizophrenia is Carlos Larrauri, a psychiatric mental health nurse practitioner who also lives with schizophrenia. Mr. Larrauri co-chairs the steering committee for the Accelerating Medicines Partnership Program Schizophrenia AMP, which is working to identify early indicators of schizophrenia. To learn more -- or read the transcript -- please visit the official episode page. Our guest, Carlos A. Larrauri, MSN, is co-chair of the Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) and has formerly served on the National Alliance on Mental Illness (NAMI) and NAMI Miami-Dade County Board of Directors. Diagnosed with schizophrenia at 23 years old, access to quality mental health care, community-based treatment, and early intervention afforded him the best opportunity for recovery. Mr. Larrauri is pursuing a law degree at the University of Michigan Law School and a concurrent master in public administration at the Harvard Kennedy School, where he was Zuckerman Fellow at Harvard's Center for Public Leadership. He's board certified as a family nurse practitioner and psychiatric mental health nurse practitioner and formerly lectured at the University of Miami and Miami Dade College. Mr. Larrauri aspires to interface advocacy and research to reduce health inequities for people living with mental illness. To learn more about Carlos and his work, visit his website or his LinkedIn. The Accelerating Medicines Partnership® (AMP®) program—Schizophrenia (SCZ) is a public-private partnership between the National Institute of Mental Health (NIMH), the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and multiple public and private organizations. Launched in 2020 and managed by the Foundation for the National Institutes of Health, the AMP SCZ program addresses the critical need for more effective treatments for people with schizophrenia and related mental health conditions. The overarching aim is to improve our understanding of disease pathways and identify new and better targets for treatment. Our host, Rachel Star Withers, creates videos documenting her schizophrenia, ways to manage and let others like her know they are not alone and can still live an amazing life. She has written Lil Broken Star: Understanding Schizophrenia for Kids and a tool for schizophrenics, To See in the Dark: Hallucination and Delusion Journal. Fun Fact: She has wrestled alligators. To learn more about Rachel, please visit her website, RachelStarLive.com. Our cohost, Gabe Howard, is an award-winning writer and speaker who lives with bipolar disorder. He is the author of the popular book, "Mental Illness is an Asshole and other Observations," available from Amazon; signed copies are also available directly from the author. Gabe makes his home in the suburbs of Columbus, Ohio. He lives with his supportive wife, Kendall, and a Miniature Schnauzer dog that he never wanted, but now can't imagine life without. To learn more about Gabe, please visit his website, gabehoward.com. Learn more about your ad choices. Visit megaphone.fm/adchoices

Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Drew. In this episode, I discuss bioequivalence studies and generic drug development. I will refer to guidance documents from both the European Medicines Agency or EMA and the US Food and Drug Administration or FDA. First, I will start with a discussion of the definition of bioequivalence or BE. Then I will discuss the statistical basis for bioequivalence and how you can leverage that for study design. And I will end with some unique challenges related to bioequivalence. Throughout, I will give practical suggestions based on my experiences in the past with BE studies. Links discussed in the show: • EMA guidance on bioequivalence • FDA guidance on statistical approaches to bioequivalence (December 2022) • FDA statistical approaches to BE (January 2001) • FDA guidance on BE studies (2022) • FDA product-specific guidances on BE • Lecture from Helmut Schütz on finding intra-subject variability (or CV%) for power calculations • PowerTOST R Package • You can connect with me on LinkedIn and send me a message • Send me a message • Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

Sonia Elijah is an independent investigative journalist and former BBC researcher. She has written numerous forensic-style investigative reports, which have uncovered major conflicts of interest and malfeasance. In particular, her analytical reports on the Pfizer-BioNTech COVID-19 vaccine: the clinical and non clinical trial documents, as well as the vaccine safety reports compiled for the US Food and Drug Administration and European Medicines Agency, have received world-wide attention. Sonia's passion is to deep-dive into public interest stories, which the mainstream media avoids. In this conversation we learn some shocking truths about the truth behind the mRNA jabs, the betrayal of our regulatory bodies and the incredible harm being done to pregnant women and children as a result of these so called vaccines. Please see Sonia's Subtacks for links and references. Links - Please follow Sonia on twitter: ⁠Sonia Elijah Her substack can be found here ⁠Sonia Elijah Substack About Doc Malik: Orthopaedic surgeon Ahmad Malik is on a journey of discovery when it comes to health and wellness. Through honest conversations with captivating individuals, Ahmad explores an array of topics that profoundly impact our well-being and health. ⁠Subscribe to the show⁠ and join our mailing list. ⁠Support the show⁠ and have access to exclusive contents and perks.  To sponsor the Doc Malik Podcast contact us at ⁠hello@docmalik.com⁠  You can follow us on social media, we are on the following platforms: ⁠Twitter Ahmad⁠ | ⁠Twitter Podcast⁠ | ⁠Instagram Ahmad⁠ | ⁠Instagram Podcast

Medicines safety monitoring is a continuous process that begins with pre-marketing clinical trials and continues with post-marketing studies to fill any gaps in knowledge. With Marianne Lunzer from AGES and Sanja Prpić from HALMED, we review the pros and cons of various study types and the importance of testing medicines on diverse populations.Tune in to find out:How pre- and post-approval safety studies are connectedWhy safety assessors can request studies in underrepresented populationsHow new regulations are impacting safety assessments in the EUWant to know more?This review in Trials summarises the methodological challenges of assessing drug safety in clinical trials, while this study in Clinical and Translational Science reviews how sex, racial, and ethnic diversity in clinical trials have changed in recent years. Post-authorisation safety studies can be imposed or voluntary and can be carried out as clinical trials or as non-interventional studies. Read about the differences on the European Medicines Agency's website.Large simple trials can control for biases in observational research while still providing results that are generalisable to real-world use. This review in Drug Safety explains why.The new Clinical Trials Regulation harmonises how EU trials are assessed and supervised for increased safety and transparency. As part of these efforts, the SAFE CT project aims to facilitate clinical trial coordination and safety assessments in the EU.For more on clinical trials, revisit this conversation with Peter Doshi on restoring invisible and abandoned trials.This episode is the last of a three-part series on sources of evidence in pharmacovigilance. Listen to the first two episodes here:The evidence for signalsUnlocking the power of real-world dataJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Sponsor special: Up to $2,500 of FREE silver AND a FREE safe on qualifying orders - Call 855-862-3377 or text “AMERICAN” to 6-5-5-3-2“Here we are three years into this, with a virus that has evolved into something that for most people is a common cold, shots that are expired because the variants they cover are all extinct—I mean, it's an absurdity that the shots are even on the market at all—and yet, we're still seeing brilliant physicians and educators and scientists being attacked for simply calling out the truth.”At the Front Line COVID-19 Critical Care (FLCCC) conference last month, I sat down with pathologist Dr. Ryan Cole to discuss autopsies and excess deaths rates allegedly related to the mRNA shot, and to dig into what has actually been found in the vials of these shots, as well as what studies are being done to differentiate between spike damage caused by the virus, versus the vaccine.“There are two dangerous things in these vials—that's a lipid nanoparticle, and a gene sequence that's making your body make foreign proteins,” says Cole. “When a FOIA request was done of the European Medicines Agency, they found out that these vials were only about 50 percent pure mRNA, meaning they can potentially code for these other proteins for which we don't even know what they're going to do. And instead of saying, ‘Yeah, you need to purify your product and make it better,' they said, ‘Okay, we'll lower the standard to 50 percent.'”We also discuss the curious emergence of what doctors are calling “turbo cancers,” and how they potentially relate to the COVID genetic vaccine.“What's happening is these cancers we are used to seeing, their growth patterns and their behavior are completely out of character … So ‘turbo cancer' is something that wasn't there and, all of a sudden, it's everywhere,” says Cole.He believes one of the biggest tragedies during the pandemic has been the loss of curiosity, and considers it tragic that so many people are afraid of having to pay a consequence for telling the truth.“All doctors and scientists agree when you censor the ones who don't. And so this construct in dialogue and free speech of not allowing a contrary voice to come into the conversation means science isn't being done. If you can question it, it's science. If you can't question it, it's propaganda,” says Cole.

Today on The Richard Syrett Show: Tracey Wilson, V.P. of Public Relations for the Canadian Coalition of Firearm Rights talks about the Trudeau Govt announcing an annual day against gun violence. Jay Goldberg, Ontario Director for the Canadian Taxpayers Federation discusses the mission cultural fund being cancelled. Heather Mason, founding member of caWsbar brings up the "Keep Prisons Single Protest". Cardiologist Dr. Peter McCullogh shares how the European Medicines Agency admitted that the COVID-19 jabs can have adverse effects on female fertility. Reporter for True North Andrew Lawton elaborates on David Johnston's refusal to resign despite a vote in the house. Matt Duffy, host of "Who Does Improv Anyway?" on Sauga 960, previews his new show.

The COVID mandates might have ended, but the human experimentation continues. I warn how companies and governments are about to unleash RSV vaccines that are just as deadly. The policies have still not changed. Next, we are joined by U.K. investigative journalist Sonia Elijah, who has discovered documents from Pfizer's partner BioNTech and the European Medicines Agency that show how they knew from day one that the shots are dangerous to all people, cause injuries in every organ system, are particularly concerning for pregnant women, spread through the mother's milk, and cause ubiquitous menstrual irregularities. To this day, they refuse to recognize the problems and have now created a permanent regulatory scheme in which any vaccine is innocent until proven 100% guilty, the opposite of the precautionary principle in the Nuremberg Code.   Learn more about your ad choices. Visit megaphone.fm/adchoices

This week we do our best to explain how next week's elections work (shout out to the water boards!), why the TV debates are between politicians who aren't standing in them and why Mark Rutte is shadow boxing with a 'leftist cloud'. Justice minister Dilan Yesilgöz is under pressure over failures in the crown witness protection system. The European Medicines Agency is displeased about the personal treatments Amsterdam city council plans to offer in its neighbourhood. In sport, there's good news in athletics, football, skating, cycling and baseball. And we report on the exotic invaders who are accused of tearing up the neighbourhood, holding raucous parties and driving up your energy bill.

Did you know that a new dengue vaccine has been approved by the European Medicines Agency? Credit available for this activity expires: 01/09/24 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/986481?ecd=bdc_podcast_libsyn_mscpedu

The European Commission has authorized the world's first one-dose drug against a respiratory virus that sickens millions of babies and children globally every year. In a statement, drugmakers Sanofi and AstraZeneca said the European Commission had given the green light to nirsevimab, a laboratory-developed antibody designed to protect infants during their first exposure to RSV, or respiratory syncytial virus, a highly contagious common infection that infects nearly all babies by age 2. At the moment, babies at high risk of the disease can be given monthly shots to protect them during RSV season. In September, the European Medicines Agency recommended that nirsevimab, sold as Beyfortus, be authorized based on advanced research that showed the drug reduced the chances that babies with RSV needed medical attention and appeared to be safe, compared to infants who got a dummy treatment. The drug is given in a single injection. “We are excited about the opportunity to expand prevention efforts to all infants,” said Silke Mader, co-founder of the European Foundation for the Care of Newborn Infants. In the U.S., RSV is causing an early surge of infections in children's hospitals this year. European health officials are warning there could be a similar spike across the continent. For most healthy people, RSV is a cold-like nuisance. But the virus can be life-threatening for the very young and the elderly. The virus can infect deep in the lungs and in small babies, it can impede breathing by inflaming their tiny airways. RSV kills about 100,000 babies annually, mostly in developing countries. Nirsevimab was developed to give newborns and infants immediate protection against RSV through an antibody to prevent infections in their respiratory systems. In November, Pfizer announced preliminary research showing that a new vaccine given to pregnant women could help protect their babies against RSV, after decades of failure to develop an effective shot. This article was provided by The Associated Press.

  Vidcast:  https://youtu.be/874VfupQy_I   Pfizer has developed two Omicron-targeting boosters: one is their Omicron BA.1 adapted vaccine and the other is their Omicron BA.4/BA.5 adapted vaccine.  The former has been tested in humans while the latter has only been tested in mice and human studies are expected to begin soon.   Pfizer has applied to the FDA and the European Medicines Agency for EUAs for both versions.  The BA.1 version contains mRNAs that encode for the antigens associated with both the original CoVid version and the Omicron BA.1 subvariant. The BA.4/BA.5 version contains the same mRNAs that encode for the antigens associated with both the original CoVid version but also mRNAs the encode for  Omicron BA.4 and BA.5 subvariant antigens.   Pfizer has human data only for the BA.1 version and that shows a 9.1 fold rise in protective antibodies against BA.1.  There is no human data regarding this booster's protective antibodies against BA.4/BA.5.  The mouse data shows shows a good protective antibody boost.   The FDA has today approved the BA.4/BA.5 adapted version without human test data.  Scientists there have accepted Pfizer's argument that this booster is fundamentally similar to their original vaccine and BA.1 booster in efficacy and safety.  We'll see tomorrow what the CDC decides before release to the general public.   https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-omicron-adapted-covid-19   #pfizer #CoVid #vaccine #booster #omicron #ba1 #ba5  

In this podcast, Latesha Elopre, MD, MSPH discusses options for pre-exposure prophylaxis (PrEP). Listen as she explains best practices for the nonpharmacologic prevention of HIV, as well as oral and injectable pharmacologic PrEP options.Presenters:Latesha Elopre, MD, MSPHAssociate ProfessorDivision of Infectious DiseasesUniversity of Alabama at BirminghamBirmingham, AlabamaModeratorJason Farley, PhD, MPH, ANP-BC, FAAN, AACRNEndowed Professor of Nursing Leadership and InnovationJohns Hopkins University School of NursingDirector, Center for Infectious Disease and Nursing InnovationAdult Nurse Practitioner, Infectious DiseasesJohns Hopkins MedicineBaltimore, Maryland

https://www.metaculus.com/notebooks/10685/malaria-and-the-historic-rtss-vaccine/ The following essay was contributed by public health researcher Jon Servello.   This essay makes extensive use of abbreviations. The list can be found here. Malaria caused 627,000 deaths in 2020, largely among children under five years of age in sub-Saharan Africa. Interventions aimed at preventative treatment could save a considerable number of lives, bring about long-term economic benefits to countries with endemic malaria, and yield substantial benefits to humanity as a whole.  After decades of varied success in vaccine development, a four-dose regimen of RTS,S/AS01 (brand name Mosquirix) showed promising initial results in preventing clinical disease from Plasmodium falciparum at 11 trial sites across west and central Africa, though this quickly declined to an average of 25.9% efficacy in the 6 to 12 week old age range, and 36.3% in the 5 to 17 month range. The European Medicines Agency licensed the vaccine in 2015, and RTS,S/AS01 is being rolled out via the Malaria Vaccine Implementation Program (MVIP) by the World Health Organization in Ghana, Malawi, and Kenya.

In part two this ASCO Education Podcast episode, hosts Dr. David Johnson and Dr. Patrick Loehrer continue their conversation with Dr. Richard Pazdur, director of the U.S. Food and Drug Administration's Oncology Center of Excellence, focusing on his leadership and vision for improving cancer care worldwide. The conversation includes reflection on drug toxicities, approval processes, and complexity of clinical trials. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at education@asco.org.   TRANSCRIPT Dr. Pat Loehrer: Hi. I'm Pat Loehrer, the Director of Global Oncology and Health Equity at Indiana University. Dr. Dave Johnson: And hi. I'm Dave Johnson at UT Southwestern in Dallas, Texas. Dr. Pat Loehrer: This is the second half of our Oncology, Etc. conversation with Dr. Rick Pazdur, who's the director of the FDA's Oncology Center of Excellence. In Part 1, we chatted with Dr. Pazdur about his upbringing and his early career. Today, we're going to focus on his leadership and vision for improving cancer care worldwide. But first, we'll discuss how cancer has impacted his life personally.   I want to flash-forward. I had the pleasure of knowing Mary. And there was no question, if you had a problem in oncology, you would go to Mary and not Rick Pazdur when you were a house staff member. But moving forward a bit, I'm not sure if all the listeners know that Mary came down with ovarian cancer. Dave himself had cancer. My wife had breast cancer. It is incredibly hard to be an oncologist I think when your spouse or someone who's close to you has cancer, and particularly, being married to a medical oncology nurse. Maybe just share a little bit about that journey of being a husband of a- Dr. Richard Pazdur: Yeah. It is interesting because going back to the Rush story, the first patient that my wife and I had in common, and this is so ironic, was a patient with ovarian cancer. The last patient that we had in common was her, which is some ironic fate, so to speak. And the story began of her illness was right around Labor Day. We had gone to Chicago in February driving back from Chicago. I noticed that she kept on taking a whole bunch of Tums and then saying - Oh, I just got a lot of GI symptoms, and she went to see her gastroenterologist or GP and he said, ‘Oh, this is just, you know, indigestion.' And two weeks after that or not even that, she was in the hospital with a massive amount of ascites, needed an intensive care unit. It was readily apparent just on getting her CA 125 what she had and she wound up one day in debulking surgery and then IP chemotherapy, etc. I think something that I learned, and I think we knew from the very beginning that this was not going to be a curable illness, and how to deal with that on an emotional level. And I have to give my wife credit. She spared me a lot of the emotion because she was such a strong person. She made all of her own calls as far as what she wanted. She would ask me what I thought, but she would do her own research, she would go to her own doctors' appointments. She said, ‘You don't really need to come with me. I'm self-sufficient.' She was very much interested in helping other cancer patients, and after she died, I think one of the most cherished conversations I had was a group of women that came to me and said how much she helped them during their support group because she was a nurse. She knew she was dying. She had emotional maturity not to fall apart but to accept the inevitable in a very strong way. My wife was a very religious person, had gone to Catholic schools, really embraced religion during those terminal years basically. And I think that was a great sense of comfort to her. But it did teach me a lot of lessons when you take care of somebody that has cancer, and that is, what a bad job we do with drug toxicities. Drug toxicities to medical oncologists and especially the people at the FDA are numbered, Grade 3, Grade 4, Grade 1. These toxicities are tolerable, tolerable to who, so to speak. And how to manage these toxicities and how they interrupt your life is one of the lasting experience I have, which I always will remember. And that has been one of my roles recently is forming several programs that we have in the OCE to look at dosing, to look at what is this definition if the drug is tolerable or well-tolerated or if the toxicities could be managed. I always say, yeah, every toxicity could be managed, even death. You call the undertaker to manage it. So what do you really mean by that statement. But I think the issue of toxicity is an important one. And then also going on clinical trials and having people considering what you want to go on, what risk you want to take, and what is actually in the informed consent and how meaningful that is. Dr. Dave Johnson: Really glad you brought that up, Rick. That matches my own experience with lymphoma and going through chemotherapy. And as an oncologist, one would think I would know what the side effects are. I'd recounted them dozens and dozens of times to people over the years, but until you've actually experienced them either personally or up close as you did with Mary, it's impossible to fully understand. I'll give you one example. Fatigue. Everybody thinks they know what fatigue is, but until you've had chemotherapy-induced fatigue, the fatigue that never abates, you just don't understand what it is. It's debilitating in ways that are unimaginable to most people. So I'm sure that experience certainly shaped your view and your role at the FDA. Dr. Richard Pazdur: Correct. Dr. Dave Johnson: I wonder, if you might share, you initiated a number of programs recently, including programs to try to improve coordination and co-operation amongst the pharmaceutical companies. Could you speak to some of those programs for us? Dr. Richard Pazdur: I think one of my favorite programs is Project Orbis. Project Orbis is an idea I had when I was walking down the street. It just hit me. When I came to the FDA, one of the things I rapidly noticed is how isolated the FDA was, even from the rest from the regulatory agencies throughout the world. There was very little cross-fertilization there. So one of the very first things that I did was set up a monthly tele-conference first with the EMA, the European Medicines Agency, and then we ended on Health Canada, Australia, Japan, Singapore, you name it. And one of the things that became really apparent to me, we at the FDA got applications always first—always. That's obvious. You know why they had given it to us first? The money. That's where the finances are going to be. So we got the application first, and it could be 2 years, 18 months, 12 months, that these other countries, Canada, Australia, Switzerland, and Brazil, Israel, would get these applications. And I said, well, this isn't right, really, because these people, they have cancer. They have every right to get these medications as soon as possible, and also we have such a large agency. We have 80 to 100 oncologists that work there, and most of these agencies have one or two oncologists. So our expertise in oncology at the FDA is so much greater than these other regulatory agencies. How can we leverage that to help these other countries? So we started Project Orbis, and what it was is that companies come in and they submit an application and they simultaneously submit the same application to the countries that want to participate in the program. They are all preselected and have confidentiality agreements with each other. And we worked together on the applications, basically reviewing the applications. So we had many meetings, tele-conversations, telephone conversations with countries. So that expedites these drugs. This has really had a lasting impact because from a worldwide perspective, it's really promoted more rapid development of drugs and rapid approval of drugs, and that's important because that establishes sooner new standards of care that will impact future trials. So in addition to the humanitarian issue of improving healthcare for patients in these countries, it has an impact on the global clinical trial system by having new standards approved much faster and accepted by world authorities. Dr. Pat Loehrer: Let me just jump on that for a second, just to make a comment. Back when we were growing up, there would be like three to five drugs approved- Dr. Richard Pazdur: Yeah. Dr. Pat Loehrer: And today, it's like once a week, there's a new indication for oncologists. Dr. Dave Johnson: Our listeners have another question that might be appropriate to ask at this time. What is the most common mistake that drug companies make in their applications to the FDA or in the process of trying to get their drug approved? Is there a frequent mistake that you can advise them? Dr. Richard Pazdur: Well, they don't come and talk to us. That's number one. They want, not necessarily what the best registration pathway is, but what the quickest registration pathway is. And sometimes the quickest registration pathway, especially single arm trials, are not the best registrations pathway. So my advice is rather than playing games with the FDA, to put it in the vernacular, just do the right thing and say, what is the optimal information that patients need when I develop this drug. We're seeing a lot of problems now with various drugs where people are developing in a refractory disease setting a drug, and they plan on getting accelerated approval on a response rate. So they push and push the dose. And with a single arm study, you can't really evaluate safety that well. Everything is attributed to the drug, and they want to get the highest response rate. And they get it, and there's a confirmatory study, and the arm of the confirmatory study, the control arm may not be as toxic as theirs, and we're seeing a wave of drugs that now have inferior survival compared to controls, which probably is predicated upon, they got the wrong dose. And I think that is one of the major programs that we have, that we need to address is dosing in oncology, this ‘More is better, more is better,' and ‘Let's push the dose as high as possible.' More isn't even probably good in cytotoxic days, but certainly, not a good idea in targeted therapies and certainly not a good idea in biological therapy. So we've really got to think about dosing more, penetration of targets, what's the optimal dose rather than what's the highest dose. You know as well as I do, pharmaceutical companies want to go with the highest dose because the major hurdle is the demonstration of efficacy, even in a randomized study. So nobody wants to be blamed by saying, well, you spent $100 million on a Phase 3 study and it's negative because you used too low of a dose. But then at the end of the day, we don't have a really good tolerable dose, and it's really hard to go backwards and look at dosing after a drug was already approved because the efficacy study has already been done. Dr. Pat Loehrer: The other aspect of drug companies is not only getting the dosage there, but also the duration. There is motivation for money, and so patients are going to and- Dr. Richard Pazdur: Oh, count on that. Dr. Pat Loehrer: So it begs a question, and I know the FDA can't do this, but in other countries, there is a monetary review together with the toxicity review. Can you reflect a little bit about that to the best of your ability? Dr. Richard Pazdur: Well, even within our simpler agencies, they may communicate more than we do with CMS, but all oncology drugs that when they're approved are then paid for by CMS, okay? In these other countries, that is not so. They may get approval and then they have to go to these health assessment agencies that will decide and argue with the companies what the pricing of the drug is. I think it's a mistake, honestly, for the FDA to get into pricing. We have a hard enough time with efficacy and safety, and pricing is a very ephemeral concept because it could change on a dialing. Somebody could promise you, you should approve their drug because it's much cheaper on Monday, and on Friday, they could say, 'Oops, we made a mistake. We really think that this dose has to be X number of dollars.' And you could see competition hasn't worked well in oncology with seven PD-1 drugs approved, pricing has not really been of any movement here. Dr. Pat Loehrer: I'm sorry. Dave may have another question, but let me ask you this. Going back to the clinical trials and what industry asked you- the complexity of clinical trials is going up logarithmically compared to the way they were in the ‘70s and ‘80s. In many of the trials where we have to get all this data in order to soothe the FDA, what are your thoughts about simplifying clinical trials? Dr. Richard Pazdur: Oh yeah. I'm for it. I am for it. If you really look at it, these are not FDA requirements for the most part. The companies want them, all of this data because it's controlled. They don't want to be blamed at the end of the day for not capturing this data or that data. They have developed complicated bureaucracies, going back in my sociology days there, complicated bureaucracies to gather all of this data, the whole CRO industry to go out and pester you guys in practice by doing site visits. It's a complicated situation and it's really predicated a lot on the history and bureaucracies that have been built up and not money to strip away those bureaucracies for fear of failure, so to speak, of not catching something. Dr. Dave Johnson: So Rick, we're coming to the end of our time that we've scheduled. I actually have two questions for you. We've asked all of our previous guests, the first of which would be if you could talk to your 21-year-old self today, what advice would you give yourself? After you've done that, we'd like to know what books have you been reading lately or is there some documentary that you've seen that you would recommend to us and our listeners? Dr. Richard Pazdur: I would tell myself, when I was 21 years old, relax and be less anxious. All things pass. I think we get so anxious when we're young about relatively small things. I remember my first ASCO presentation, I was petrified. My heart was beating out of my chest. I was sweating. And like relax. It's one of a thousand presentations at ASCO. We tend to magnify things, and I think age puts things in perspective. This in the reality of the world is a small thing, and people probably won't even remember it. Dr. Dave Johnson: Excellent advice. Dr. Richard Pazdur: My favorite author that I'm reading now for the last couple of months is a presidential historical author, Doris Kearns Goodwin. I think many of you know, she's written many books. I love her writing style. And I like non-fiction. I like biographies and I like history books, history stories rather than mysteries or things like that, fantasy books. The two books that I really enjoyed, the first one was No Ordinary Time: Franklin and Eleanor Roosevelt: The Home Front in World War II. I don't know if anybody's read that. It's an excellent book. Most of our attention in World War II is directed toward Europe and what was going on in Europe, the battlefields, etc., which I'm not a big fan of reading about battles and stuff, but this was what was going on in The White House and the relationships of all of the people that came there. It was like a hotel almost with the personalities that were flowing through including Churchill and various princes and queens, etc. But also the interesting relation, the fascinating relationship that Eleanor and Franklin Roosevelt had, I don't know how to describe the relationship. It truly was an unconventional relationship based on some past history that they had of affairs etc., but it was just a fascinating one. The best book, though, again I'm reading now, is written also by Doris Kearns Goodwin, and it is Lyndon Johnson and the American Dream. Doris Kearns Johnson was his biographer and spent a great deal of time with him in The White House as well as when he left The White House. But it's an excellent book on management and reading people, success. One of the things that is most interesting about Lyndon Johnson, and especially when he was running the senate before he became president, was his ability to know what motivated people and how to use that to form a consensus. Does this person want to go on this trip. I'll give it to him and then he could help me with this. Does this person want to go to this party or get on this position in congress? So it was really a skillset that he had, which I think most leaders need to know. You have to motivate people. You can't lead by an autocratic masthead, but you've got to lead from what do people want and to make sure that they feel you have a personal relationship with them. As I say to my staff, everything in life is personal—everything. Dr. Dave Johnson: Well, it's been a great session, Rick. We so much appreciate your willingness to spend time with us. We wish we had twice as much time. I'm sure we could go on for hours. Thanks again, and we appreciate all you do at the FDA. You've been a fabulous leader, and we hope you continue on for many years to come. Dr. Richard Pazdur: Thank you so much, Dave, and thank you so much, Pat. Dr. Pat Loehrer: Great to see you. Dr. Dave Johnson: Pat, before we leave, any idea why our patients seem to get sick on Saturday and Sunday? Dr. Pat Loehrer: I have no clue. Do you know the answer, Dave? Dr. Dave Johnson: Yes. They have a weekend immunity. Thank you for listening to the ASCO Education Podcast. To stay up to date with the latest episodes, please click subscribe. Let us know what you think by leaving a review. For more information, visit the Comprehensive Education Center at education.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.    

Cattle have been used in medical research for centuries, from Edward Jenner to the USDA. Whenever they turn up dead we look for diseases that could spread to humans. Sometimes when they are mutilated with surgical precision, we wonder if the cause was human, otherworldly, or perhaps both in the case of the MILAB theory. In 2022 National Geographic reported revived research into 'contagious' injections that could be spread between hosts without consent or knowledge. The goal of such research was to end bovine tuberculosis, and it dates back to the 1980s, initially being tested on rabbits in Spain in 1999. However, it was not approved by the European Medicines Agency. We know SAb Biotherapeutics in South Dakota conducted trials on cow-generated antibodies against MERS by giving them injections of genomes and proteins. In 2021 the Agricultural Research Service began experimenting with bacterium proteins to develop a 'cocktail' for protecting cattle from diseases like paratuberculosis. In 2008, the Bill and Melinda Gates Foundation gave money to Jichi Medical University in Japan to produce a 'transgenic mosquito, as a flying syringe, to deliver' malaria injections 'via saliva'. Such invisible technology is akin to neuro-grains, flying microchips, and smart dust. The goal is to hijack natural organic systems, surveil them, and influence the host. In other words, an invisible plague or pestilence.

About This Episode: Dr. McCullough is board certified in internal medicine, cardiovascular diseases, and clinical lipidology. After receiving a bachelor's degree from Baylor University, Dr. McCullough completed his medical degree as an Alpha Omega Alpha graduate from the University of Texas Southwestern Medical School. He went on to complete his internal medicine residency at the University of Washington, cardiology fellowship including service as Chief Fellow at William Beaumont Hospital, and master's degree in public health at the University of Michigan. Dr. McCullough has broadly published on a range of topics in medicine with more than 1000 publications and more than 600 citations in the National Library of Medicine. His works include the “Interface between Renal Disease and Cardiovascular Illness” in Braunwald's Heart Disease Textbook. His works have appeared in the New England Journal of Medicine, Journal of the American Medical Association, Lancet, British Medical Journal and other top-tier journals worldwide. He is the editor-in-chief of Reviews in Cardiovascular Medicine and senior associate editor of the American Journal of Cardiology. He serves on the editorial boards of multiple specialty journals. Dr. McCullough has made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), and the European Medicines Agency. He has served as member or chair of data safety monitoring boards of 24 randomized clinical trials. Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. He has 35 peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in TheHill. On November 19, 2020, Dr. McCullough testified in the US Senate Committee on Homeland Security and Governmental Affairs concerning early ambulatory treatment of high-risk patients with COVID-19. Find out more about Dr. McCullough at: Help Dr Peter McCullough with legal IT travel cost - https://givesendgo.com/G2DR5 The McCullough report - https://www.americaoutloud.com/the-mccullough-report/ Twitter - https://twitter.com/P_McCulloughMD Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection  - https://pubmed.ncbi.nlm.nih.gov/32771461/ Treatment algorithm for COVID-19-like and confirmed COVID-19 illness in ambulatory patients at home in self-quarantine. - https://pubmed.ncbi.nlm.nih.gov/32771461/#&gid=article-figures&pid=figure-1-uid-0 Check out our YouTube Channel: Jeremyryanslatebiz See the Show Notes: www.jeremyryanslate.com/960 Sponsors: Gusto: This episode is sponsored by Gusto. Run your payroll the easy way, the same way we do at Command Your Brand. You'll get a. $100 Amazon Gift Card just for running your first payroll! http://www.jeremyryanslate.com/gusto MyPillow: Use the promo code: CYOL to get up to 60% off https://www.mypillow.com/ Audible: Get a free 30 day free trial and 1 free audiobook from thousands of available books. Right now I'm reading " Rigged: How the Media, Big Tech, and the Democrats Seized Our Elections" by Mollie Hemingway www.jeremyryanslate.com/book  

Pfizer and BioNTech are requesting emergency use authorization for their two-dose Covid-19 vaccine for children age 6 months up to 5 years, the companies said Tuesday. Pfizer and BioNTech said they have initiated a rolling submission of data to the US Food and Drug Administration after a request from the agency. They expect to complete the EUA submission in the coming days and say they will also submit clinical trial data to the European Medicines Agency and other agencies around the world. The Pfizer/BioNTech vaccine is already authorized for use in people as young as 5 and would be the first Covid-19 vaccine available for the youngest children. The companies are continuing to test a three-dose version of the vaccine in this younger age group.To learn more about how CNN protects listener privacy, visit cnn.com/privacy

Welcome to The Nonlinear Library, where we use Text-to-Speech software to convert the best writing from the Rationalist and EA communities into audio. This is: Covid 1/20/22: Peak Omicron, published by Zvi on January 20, 2022 on LessWrong. The Omicron and Weekly posts are now combined, so this includes the last day's Omicron developments, which will be how it works going forward. Next week's will include the probability updates section as well. When there is urgent news, I'll supplement as appropriate. This week was the peak. From here, it would be highly surprising if Omicron cases didn't start declining. The other news is mostly more of the same, with several developments worth analyzing: The Supreme Court throws out one of Biden's mandates but upholds the other, Djokovic gets deported a second time, a great proposal to expand Manhattan (which got its own post), and other neat stuff like that. Executive Summary If you live in USA and haven't done so yet, order your free Covid-19 tests. We are at or past the peak in Omicron infections in the United States and UK, but that doesn't mean it's over yet, next few weeks still rough. UK lifts all Covid-19 restrictions, midnight is perhaps temporary after all. Let's run the numbers. The Numbers Predictions Prediction from last week: 5.6mm cases (+13%) and 15,000 deaths (+30%). Results: 4.9mm cases (+0%) and 12,606 deaths (+7%). Prediction for next week: 4.4mm cases (-10%) and 14,500 deaths (+15%). The deaths number is confusingly low this week. Cases increased by a huge amount with the three week lag, yet the deaths number isn't increasing much. There's about to be a much bigger three-week-lagged increase in cases, but the pattern is clear so my estimated size increase needs to adjust. I am fully prepared to miss low reasonably often here, if I wasn't the estimate would be wrong. For cases, it seems clear that we are peaking, so we should expect things to begin to decline. The question is how fast, with some areas not yet peaked, and the Northeast already having a much smaller share of total cases. The decline could easily be much faster than this, but things could also stay mostly steady for one more week. Deaths Even with Omicron being milder, the lack of more deaths is very good news here. The next week is the time when deaths should by all rights go much higher, so if they stay under control this week, we're fully in the clear. Cases The Northeast already peaked, as probably did a number of other large states like Illinois, Florida and California. The South might have one more week left in aggregate, it also might not. Cases at Yale in similar freefall to rest of east coast. Thread pointing out that cases are declining in many places. Trevor Bedford thread on us having peaked nationally but often not locally, including good state-by-state graphs. Expects about a symmetrical march down to the path up. Ashish Jha thinks we have peaked. Vaccinations US announces (MR secondary source, StatNews article) that. .if the Food and Drug Administration decides to update Covid-19 vaccines to take better aim at Omicron or other variants, it is unlikely to go it alone. Instead, a senior FDA official told STAT, the agency expects to take part in an internationally coordinated program aimed at deciding if, when, and how to update Covid-19 vaccines. The approach would ensure decisions are not left solely to individual vaccine manufacturers. “We can't have our manufacturers going willy-nilly [saying], ‘Oh well, the EMA decided they wanted this composition, but FDA wanted that composition,'” the official said, referring to the European Medicines Agency. “So we are very much of the mind that we would like to be part of a more global process in helping to come to what vaccine composition there should be now.” Tyler is kind: Designed for flexbility and speedy response? I guess we'll see. Here is the full StatNews article. And obviously, the entire public health community is up in arms about this. Th...

The European Medicines Agency has reported that it's aware of 25 cases of rare blood clots from people who have had the Pfizer mRNA vaccine, and 5 cases from people who have had the Moderna vaccine. The numbers were revealed during a press briefing into blood clotting issues related to the Johnson and Johnson vaccine. It's the first time such a number has been reported by a medical regulator, and may suggest very rare clotting events may not be confined only to AstraZeneca and Johnson and Johnson. The co-chair of Australia's vaccination advisory group Professor Allen Cheng has told Coronacast that there is still a lot of uncertainty, especially if reported cases have been fully investigated. So on today's Coronacast, what has the EMA said and is it real? References: EMA press conference