Risky Business: How Novo Nordisk’s Marketing Machine Turned Weight Loss Drugs Into Cardiovascular Life Savers

Louise Adams 0:00 Louise, welcome to all fired up. I’m Louise, your host, and this is the podcast where we talk all things anti diet. Has diet culture got you in a fit of rage? Is the injustice of the beauty ideal getting your knickers in a twist? Does fitspo make you want a fitspo? Are you ready to hurl if you hear one more weight loss tip? Are you ready to be mad loud and proud? Well, you come to the right place. Let’s get all tied up. Hello, diet Coulter dropouts, I’m back. Surprise. I’m so excited to bring you this epic rant about Novo Nordisk ploy to turn their weight loss drugs into heart health saviors. There is so much bullshit to unpack. I can’t believe this, but I have been podcasting since July 2017 which is seven years ago, my friends, I cannot believe how much everything has changed since then, but friends, one thing will never change my utter outrage at diet culture. So if you love us here at all fired up, please help elevate our anti diet rage. 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And there’s all sorts of tasty tidbits, talks and skills training sessions on stuff like regular eating, on how to heal your relationship with your body, binge eating, and, of course, how to make sure you can access really excellent weight inclusive healthcare. And just recently, I’ve added in a whole section on how to build self compassion skills in diet culture, we are constantly pummeled with self esteem, destroying messages, and so many of us feel not good enough in our bodies, in our habits, in our achievements and constant self criticism, it becomes internalized, and Then it gets really, really hard, if not impossible, to feel okay in our own skin. Self Compassion is like an antidote to self criticism and learning this skill creates resilience, safety and peace as we navigate the slings and arrows of life on this planet. I absolutely love self compassion, and I’m really excited to have added it to the academy. So if you’re after something really wonderful in terms of an anti diet resource and something really cheap, join the untrapped Academy now. It’s just 15 Aussie bucks. What a bargain. So again, go to untrapped.com.au and check us out. Okay, so on with the show. Let’s cast our minds back a bit. So it’s october 2023 we are in Dallas, Texas, where delegates at obesity week, the obesity society’s annual love in have been invited to a free dinner and a talk, which is called taking aim at obesity and covid. Covid health risks, take the escape room challenge, paid for with an educational grant from Novo Nordisk, this nifty event promised participants the opportunity to learn from leading experts in obesity management while completing innovative and fun virtual escape room challenges. What the actual fuck I hear you cry. I’ve been to a real life escape room with my kids, where you kind of get locked in a room, and in order to escape or unlock the door, you have to find clues and solve puzzles, and it’s a lot of fun. And Novo Nordisk who are, of course, now the new self appointed experts on weight stigma have decided that a virtual escape room where participants are answering weight loss, drug friendly questions in order to quote, unquote, escape obesity is also fun in the carnival, like atmosphere of obesity week. What’s not to love about gamifying the key talking points you want people to remember? I actually stumbled upon a recording of this because it’s still available online as an educational resource for medical people who are allowed to claim continuing medical education points for this dosh. I’ve put the link in the show notes for those who can bear it. I watched the entire thing, and it was obvious that this 90 minute education session was part of novos Machiavellian PR push for their weight loss drug semaglutide. So remembering, semaglutide at low doses is ozempic for the treatment of diabetes, and at high doses, it’s called wegovy for weight loss. So for some context, just a few months before obesity week. So in August 2023 Novo had issued a press release announcing that semaglutide At the weight loss dose slashed the risk of cardiovascular events by a staggering 20% but weirdly, they didn’t let us see the actual study, which was called the Select trial. All of them have cute names, so we only had novos talking points to chew over. But of course, the media were just having an absolute Field Day, interviewing over excited obesity researchers, many of whom had, of course, been paid directly by Novo or worse, been educated by one of their trainings. The whole media circus was just ballistic, and everyone was just gobbling up novos headlines. So all of this was happening at the time, and so the obesity week, escape room challenge, it was a lot more than just fun and games and a free dinner. It was a golden opportunity for Novo to continue to educate the obesity world about the complex relationship between excess body weight and cardiovascular disease, and of course, push their blockbuster drug and whip everyone up into even more of a frenzy. So the presentation had three people presenting it, Dr Donna Ryan, Dr Ian nearland and Dr Carolyn oppovian. All three had accepted bucket loads of cash from Novo Nordisk, the host. Dr Donna Ryan is an obesity researcher and former president of the Obesity Society, which is, of course, itself, funded by Novo Nordisk. She’s been bankrolled by them, by Novo to the tune of more than a million dollars over the last decade. So I’m going to call her million dollar Donna. Dr neeland, cardiologist, has taken $692,000 from Novo Nordisk Since 2017 and in third place. Dr Carolyn apovian has raked in $80,000 since then. This is a lot of money, and in my opinion, something the audience needs to be aware of. But at this fun dinner, there was no time for boring stuff like financial disclosures. Each presented a 20 minute slideshow, and in between, you get taken to this virtual escape room, where we see pictures of a cute cartoon doctor’s room with a larger bodied cartoon patient sitting there, and there’s glowing dots in various parts of the room, which when you click on them, up pops a really tough question for you to answer. And believe me, these questions really go to show who’s paying for dinner? Here’s an example quote which landmark clinical trial was the first to demonstrate protective cardiovascular benefits of GLP ones in patients with overweight obesity who do not have diabetes. Lo and behold, it’s Novo select trial, and when you get it right up pops a little explainer box with a massive 20% with a big down once arrow next to it, just in case you hadn’t already had that number like imprinted onto your brain. It’s cringe worthy to think that this is what passes for medical education in the 21st century. So. Million dollar Donna, in my opinion, she’s not a smooth talker for someone who’s been paid as much as she has, but what she lacks in speaker finesse, she makes up for in pure doggedness, in driving home novo’s key messages. I’m going to play you a bit of audio of her talking with her co presenters, Speaker 1 10:19 so highly enthusiastic about the results of select and the potential that it has to help our patients before we do the escape room, I want to, I want to ask you, Caroline and Ian, what you make of this. So, Caroline, I mean, what are the potential implications for selecting clinical practice? Speaker 2 10:38 Well, we finally have data that shows unequivocally now that weight loss and the use of a GLP one compared to placebo, will reduce the risk of cardiovascular events so and it’s because of the degree of weight loss. Since we didn’t see that kind of data come out of look ahead, it’s probably because of the degree of weight loss. So finally, we have agents that can give us that kind of weight loss greater than 10% now we need to see what the weight loss really is at the American Heart when they unfold the data, and Speaker 1 11:23 we’ll need to do the mediation analysis to see how much of this is being driven by weight loss and how much is being driven by the drug itself. Louise Adams 11:32 I mean, this, it’s just, I mean, it’s laugh out loud, unbelievable. Carolyn is literally claiming in the same sentence that the Select trial is unequivocal proof that weight loss reduces cardiovascular risk and that the reduction in risk is definitely because of the amount of weight loss. But she’s also admitting that she actually has no idea what the weight loss in select was or whether it was actually related to the risk outcome to her credit, million dollar Donna is at least saying that they should do an analysis to tease this out. But if this is the case, what are any of them actually even doing up there? This is just a disgusting example of how dangerous these paid off researchers, pre existing bias is. If they weren’t responsible scientists, they would be waiting to read the actual study before making any claims. I don’t know what kind of world we’re living in when a press release can become an entire educational workshop. It just made me so mad I needed to rent and I knew just the person to do this with. So my guest today is the great Reagan Chastain, dear friend of the show and weight inclusive warrior, as you all know, she’s a living legend and a tireless whistleblower. She’s a writer, a speaker, medical researcher, board certified patient advocate, a multi certified health and fitness professional and a thought leader in weight science, weight stigma and healthcare. She’s the genius behind the sub stack weighted healthcare.com and co author of the Health at Every Size health sheets. She is a powerhouse, and she shares my obsession with exposing Novo Nordisk. So I had a great chat with her about this massive marketing machine which is turning their weight loss drugs into cardiovascular life savers. A bit of a heads up in this chat, we’re diving deep into the world of obesity, so there are a lot of O words. Please know listeners that I just don’t agree with the concept of obesity, and I think the term is derogatory, it’s terrible science, and it just needlessly pathologizes glorious body diversity. We’re also talking in depth about things like weight loss, and there’s just a lot of information in the following conversation that might make listeners throw things. So be warned. So here’s me and wonderful Reagan. Reagan, tell me what’s firing you up today. What Ragen Chastain 13:55 is firing me up is that either Novo Nordisk is purposefully misleading people, or their researchers don’t have high school statistics skills, so either or not, a good situation. Louise Adams 14:07 I have been dying to unpack this with you for such a long time, and I’m so happy that we actually get to do this now. Who would have guessed that Novo Nordisk might be up to some stuff that needs to be unpacked. But here we are shocking, shocking. So we’re going to start in August 2023 when there was a press release from Novo Nordisk that claimed that their amazing weight loss drug wegovy semaglutide, which is, of course, the ozempic drug that it reduced major adverse cardiovascular events by amazing 20% Ragen Chastain 14:48 yes, in adults with, quote overweight and quote obesity. And I think that’s important, because every single one of those is either misleading or a straight up lie, Louise Adams 14:57 basically that just the head. Line of the press release is why we need to do an entire podcast, just because there is like a lasagna of bullshit that needs to be dissected layer by layer. So this press release was touted as proof that weight loss leads to health improvement, and they also announced in the same press release, completely coincidentally, that they were going to use this breakthrough to pressure the regulators to include an indication to list their weight loss drugs as cardiovascular helpers. The first thing that struck me about this book was that there’s no actual study being released on the site. Yeah, there’s a company announcement. Yes, I press release. And in spite of the fact that there was no actual research to back, this is a claim like and I, when I read that, I’m like, oh, imagine, like, non diet, people just decide to release a press release claiming something without a study how that would be received by the planet, yeah, but it seems like in the post ozempic world, that evidence isn’t actually necessary, because the I don’t know about you, but over here, the press and the media, it was just gushing. It was disgustingly positive. Yeah. Oh, Ragen Chastain 16:20 it was. It spread like wildfire. The claims went completely unquestioned. And I’m just like, show us the research. You cowards like, at the very least, you should publish this at the same time you put out this company announcement. But it seems to be, I’m seeing them do it over and over again, and their partners do it as well. Where you get the press release out, you get all the press you want. And like, their stock went up in the United States 70 17% on the day that this company announcement was made. And so then by the time the study comes out, the story is already done, and people are like, Oh, we’re not going to redo this study, or we talk about Louise Adams 16:55 it. The talking I totally great strategic. The talking points like Novo influenced the whole narrative by doing these like talking points and getting people to repeat them over and over. If we hear anything repeated over and over, we’re going to it’s going to start sticking. And so one thing we kept hearing is that 20% reduction slashes the risk of heart attacks and things like that by 20% in their select trial, which, of course, they didn’t bother releasing at the same time, and then they used so all the media was like quoting obesity researchers who were gushing shamelessly, and so often the researchers who are quoted in the media have relationships with Novo Nordisk which of course, are not disclosed in that news article. It’s just such a like media frenzy and beat up, and it’s just Novo Nordisk being this Machiavellian kind of figure, just playing us like a violin. Yeah, yeah. Ragen Chastain 17:58 It’s just they’ve taken what the weight loss industry has been amazing at, which is taking a product that doesn’t work and making billions with it, and they’ve turned it into an absolute art. They’ve become the best of the best at it. It’s really horrifying. Louise Adams 18:12 Yeah, it’s, yeah, it’s, it’s like the maestros, it’s terrifying. So they made everyone wait around until November 2023 when they actually released the results of what’s called the Select trial. And this was like a packed press release at a standing room only event at what’s supposed to be a Scientific Session of the American cardiology people. It’s just it’s turned into theater. Yeah, yeah. And you’ve done some really fantastic digging into the authors of the Select trial, and you’ve found some interesting facts about these people. So Ragen Chastain 18:49 in terms of the conflicts of interest, it’s a conflict of interest Palooza, wherein the trial was designed by Novo Nordisk and what they call the quote, unquote, academic steering committee. And that academic steering committee took a collective of at minimum, 7.5 million plus. And again, that’s just here, the healthcare providers who are listed on openpayments.gov, that doesn’t include many of the authors and the money that they’ve taken. So the at minimum here we’re talking about $7.5 million Louise Adams 19:22 so Novo Nordisk had like hoarding the data and refu because I think that you had a look at their supplementary index that there, because clinical trials nowadays, because there’s so much pressure on the release of data and sharing of data, because without Scientists being able to interrogate data. We’re just becoming victims of marketing. Yeah. So clinical trials are being asked to produce, like, what they call, like a data sharing statement, like basically saying, Are you guys gonna share the data so we can actually see if you’ve mucked around with it? Ragen Chastain 19:54 Yeah. So it’s a statement and asks, I don’t know, maybe 10 or 15 questions, but. Their entire answer was no, which is like replicatability. Replication of studies is one of the foundations of good science, right? We can do statistical tests, we can look at p values, but actually replicating a study is the foundation of good science and showing that what your results are consistent, and so by not sharing data, they rob us of the opportunity to try to replicate their study, let alone just the ability to properly analyze it Louise Adams 20:31 fully. So dodgy. I had a look through the what they did do they’re trying to convince us is totally above board. So it says that they gave so they own the database. They did all of their statistician who they paid, did all the stats, and then they provided what they call study tabulation, data modeling, so stdm files to a consulting company called statogen, which is a firm that works for the pharmaceutical industry doing what they call, ironically independent reviews of the Novo Nordisk statistical analogy. And I looked at what an SDM, stdm is, and it’s essentially a standardized format of data that these companies need to give to regulators like the FDA from the sponsors, but it’s an interpretation of raw data. So it’s just a slice of the raw data collected from Novo given to a consulting company. The consulting company verifies what the Novo Nordisk statistician has done. But again, statuden doesn’t even have the raw data. They’ve got this slice then started in gives a certificate of authenticity back to Novo Nordisk. Novo Nordisk then hand this beautifully laundered set of data to the academic authors of this scientific research article. The actual authors, like, these are academics. Like, I think, like, when I read an academic article, I’m like, these are academics. So they’re nerds. They’re doing the research, they’re doing the stats. They’re across everything, because that’s what you have to do. But these people only see whitewashed data sets and a certificate from a Novo Nordisk paid consulting company. They never see the raw data, and that’s what they’re writing this paper based on. So I don’t know about you, but I’m totally confident right now. Ragen Chastain 22:30 Yeah, sounds great. I’m trying to imagine, I’m trying to think back to being like a freshman in college and taking my first research methods class, and if I had said, yeah, actually, I’m not going to provide you with the data. I’m going to provide you with a slice of the data that I hand picked and then gave to an organization that I paid to certify it, and then you just write the study based on that, and that’s going to be fine. I’m trying to think about if they would have just failed me, or if they would have actually told me to leave the program. I’m not sure, definitely one of those things, possibly both. But, yeah, Louise Adams 23:03 it’s a feeling, right? And you might have been hired by Novo Nordisk. Ragen Chastain 23:08 Why did I work so hard in all these classes? If this is what we were going to do, Louise Adams 23:13 holy crap. We haven’t even started talking about this yet. It’s a big picture, Novo Nordisk have done this the lecture because they need an actual health reason that their weight loss drugs that are very expensive are a seriously good idea for our global public purses to subsidize their drugs. And I think that they’ve chosen a very safe bet here, because wegovy as a GLP one medication, the active ingredient is semaglutide. And in diabetes, patients in lower doses, semaglutide, which is known as ozempic, really does have an impact on reducing cardiovascular outcomes. So they already knew that in people with diabetes, there was a slight reduction in cardiovascular risk. So doing this same kind of experiment in non diabetic people with their weight loss version isn’t a high risk clinical trial. It’s a really safe bet and quite clever from that perspective. Yeah, Ragen Chastain 24:17 and that because they need that weight loss dose like That’s exactly it, it’s got to be that 2.4 milligram dose, and because otherwise it’s no use to them to sell the weight loss medication. And so they didn’t test it. Maybe these effects can be found at point five milligrams. We don’t know, because they didn’t test anything. They really focused on that 2.4 milligram dose. And so it that was a bit of a disingenuous choice Louise Adams 24:40 as well. Slightly indeed, it’s almost, it’s almost something that’s a very plausible, different explanation is being overlooked because they just want to push the weight loss stuff. But as we’ll see later on, I think you’re spot on with that observation. There’s no way, for example, no. NOTICE would have picked like a gastrointestinal outcome improvement, Ragen Chastain 25:05 reduction of ileus. I don’t think so. Probably Louise Adams 25:08 not gonna. And the cardiovascular thing is big in weight loss drug world, because famously, the last drug to get taken off the market in 2010 which was the subbucha, mean, the reductile, or Meridia, that actually was given to large people to reduce heart attack risk, and then when they did the long term outcome studies, they found that it increased risks they had to take off the market. So there’s a real kind of like perception, I think, in the obesity researcher community, wow, weight loss really can help cardiovascular risk, but they’re just recovering from a shame spiral of accidentally killing so many people in the past Ragen Chastain 25:45 and Fen Phen Redux. Like I really feel like nobody’s thinking they’re lucky stars that this drug hurts people in a different system. It’s Oh, it’s not the cardiovascular system. We’re golden. This is fine. Look Louise Adams 25:58 over there. Ragen Chastain 26:02 Hey. No, attention to the gastroparesis in the corner like it’s ridiculous. Louise Adams 26:08 Yeah, yeah. So we probably should talk about what the Select trial was. Now we can get there. So it’s a five year study. There was 17,600 people from 41 countries who are involved in this. There were 841 different sites that people were taken from. And I think I’ve talked in the past on other podcasts about how, like in the wegovy trial and the saxenda trial, like we didn’t know anything about these trial sites. So like, who these people were, there is actual info for this, which I’ve seen stuck down quite a statistical rabbit hole with for too long. But I did some data crunching. There was three big groups. There was like 3600 people from the USA. The next big group was from Russia, with 14 191 people. And then the third biggest group was South Africa, with 800 people. So those are the three biggest groups. The rest of them are like all over the place. There’s Thailand, Japan, there’s India, there’s Ukraine, awkwardly, there’s Australia. Australia only had 327 people. So lots and lots and lots of people from lots and lots of different places, and you can see that they’re taken from all like there’s tiny amounts of people from all over the place, like universities, hospitals, endocrinologists, medical centers. So there’s like tiny groups of people being siphoned up into Novo Nordisk giant database. So it’s interesting, isn’t it, because no one can really see the big picture, except Novo in their crown of Denmark, and the quote Ragen Chastain 27:50 that I thought was most ridiculous and most telling about this from the study, they said the study was executed on six continents and in 41 countries, but they still ended up with 72.3% cis men and 83.9% white people. Louise Adams 28:08 And they say Ragen Chastain 28:09 the study wasn’t designed to reflect the diversity of the countries that it was conducted in. Why not? You have all this money, all this time, all these people. Why didn’t you do better than this? So Louise Adams 28:22 many white people, 30% of the countries, were predominantly non white, yep. And so many men Reagan like what they Ragen Chastain 28:32 seem, but the weight loss studies were almost all women. So that’s really odd to me, that they can find they’re still almost all weight but almost all women for the weight loss studies, and then almost all men for the cardiovascular like Louise Adams 28:45 73% of this sample ended up being male, yeah, which is totally, I think, a 70 something percent with mostly female in the weight loss studies. I don’t know what that tells us, but it’s an Ragen Chastain 28:59 interesting thing to ask, Do women tend to have more effect than the weight loss, and men tend to have more effects in the and I don’t mean to give away the ending, but the answer in the cardiovascular study is yes, men did tend to have a greater effect. Yeah. It’s just Yeah. Really interesting. There’s Louise Adams 29:18 also the kind of gendered aspect of perhaps men, sick men get health care. Yeah, I don’t know very strange, but to be involved in the study, they were they they really stacked the deck here, because they obviously want an outcome. They want to see a reduction in cardiovascular outcomes, because a lot of money is riding on it. So they picked people who you had to be over 45 you had to be not diabetic, you had to have a BMI above 27 which, again, weird, cut off. And you had to have established cardiovascular disease, so a history of a heart attack or a stroke or peripheral coronary artery disease. So these, they look. For people who are already sick in terms of cardiovascular and I want to point out that group of characteristics you’ve just mentioned, Novo Nordisk defines as adults Ragen Chastain 30:11 in their headline, that’s Louise Adams 30:15 the press release, the Ragen Chastain 30:16 reduction of 20% in adults with quote, unquote, overweight or obesity. And in fact, it’s over 45 with existing cardiovascular disease, without type two diabetes and a BMI. Over 27 these are making and if you’re out there wondering, making up definitions for categories in terms that have established definitions, not actually a research methods best practice, that Louise Adams 30:37 quite weird. Oh my gosh. So we ended up with all of these. So the average age in the population was 61 so that they’re quite old. And then they enrolled them between october 2018 and march 2021, which is interesting because it’s before wegovy was even approved in almost all places on the planet. So everyone in this trial is being treated off label, the semaglutide. So they basically split the groups into two, gave them either the wegovy dose or the placebo, and then they’ve waited for outcomes, which is quite kind of ghoulish, just sitting around waiting for people to have cardiovascular events, and they were anticipating that the trial would go anywhere from two and a half to five years. Yeah, Ragen Chastain 31:27 which is a trick that is sometimes done when they’re looking for a statistically significant outcome, they will just run the data continuously, and then when they hit a point where they have a statistically significant outcome, they will stop the trial. So it’s always suspect when they’re like, We don’t know two years to six years like, whatever that, to me, is a red flag that they’re just continuously running the data so they can pick a point to stop the study and say these were our results before they become non statistically Louise Adams 31:54 significant. Again, this aspect of the trial is absolutely fascinating to me, because you’re right. It’s not like science isn’t supposed to be about like, keep doctoring the data until we find what we want and then pause it. We’re meant to set a period of time and then run the study. That’s not what happened. And then, have you looked at the independent data monitoring committee? No, go ahead. This is again, me with too much time on my hands. So Novo Nordisk said that they had access to the raw data. So did this thing called the independent data monitoring committee, which is set up for big clinical trials that last a long time with kind of high risk stuff, like when we’re talking about heart stuff. So it’s not an uncommon thing in science, but what they’re supposed to do is to be completely separate from the sponsor, completely separate from profiteering or kind of vested interests. And they’re meant to monitor primarily safety. And when I looked at the independent data monitoring committee for novo, there’s seven members, all of them have been paid by novo. One guy got 20 grand just for travel and hotels. So there’s quite a lot like, there’s so many payments, and all I could see out of the seven were for like, three of the American people. Because, as you said, Open payments means we can actually see like, that. So you can see when Novo like how often and frequently Novo are paying them. So I think it backs up what you’re saying, which is Novo are asking these researchers to continuously monitor that data, looking for statistically significant events and stuff like that. So number one, the independent data monitoring committee are not independent. Shocking. And number two, like, it’s just, it’s so funny, because in 2022 Novo had a shareholder meeting, so all the shareholders are there. All of them know that the Select trial is going on, and they’re all money guys, so like, rubbing their hands together, and they’re like, Okay, hey, what’s the outcomes? Are we stopping the trial early? Because they want to stop it early, right? Because if they stop the trial early, they can get the regulatory approval, they can sell more drugs. And there was this massive kind of problem in this meeting, because Novo is saying, We’ve had feedback from the data monitoring committee, and we’re not going to stop it early. We’re going to go full five years. And the shareholders were really pissed off. And they were asking, novo, come on, tell us, have you seen the data? Is there a strong outcome here or not? And they were literally saying, cheeky buggers, we haven’t seen the data. We’re just going off the data monitoring committees, advice, come on, you have the database. Then I realized that Lars Jorgensen, who is the CEO of Novo, he was asked, I think, the year before, like, what kind of outcomes he was expecting to see, and he said, literally, I think we’d need to see a two. 80% reduction in order to make it actually viable. And then, lo and behold, amazing. Ragen Chastain 35:06 Can you believe it? But it wasn’t really 20% Oh, no, Louise Adams 35:11 let’s go there. Shall we? This is fabulous, and this is, I guess we’ve spent a long time getting here, but the risk thing is really shitty. Yeah, Ragen Chastain 35:22 of all the misleading statements in their company, announcement, headline, and there are many, I think this is the most misleading. So what they’ve done, there’s a couple different kinds of relative risk reduction. This as there’s relative risk reduction and absolute risk reduction, and relative gives you the difference between the two groups in the trial relative to each other. This does not tell you how this will likely impact the general public. For that, you need absolute risk reduction, which is just the difference between the two groups, right? So there were, there was an 8% incidence of the major cardiac adverse cardiovascular event, 8% in the placebo group and 6.5% in the treatment group. So the actual risk reduction, the absolute risk reduction, what the average person could expect is a 1.5% reduction, not 20 and literally, anyone who took even high school statistics should know this, and it’s actually worse than that, because when we look at the statistical significance, it was only statistically significant for these cis white men with an average age of 61.6 not for women, black people, Hispanic people, or those at the highest end of the weight spectrum. And so it’s an incredibly narrow group who’s going to have an incredibly small effect, and while that may be great for them to have a 1.7 1.5% reduction in major adverse cardiac events, it’s far from a 20% reduction for all adults who meet these criteria. And that’s what Novo Nordisk company announcement misled everyone to believe. Louise Adams 36:56 The 20% reduction is everywhere I have seen like the act. I mean it, and it’s famous in statistics, it to be very misleading, yes, and we’re taught in statistics that if anyone’s using relative risk reduction without telling us more like they’re selling something, yes, but this literally seems to be the standard, and no one is questioning it. This is really people just trying to make something look much more effective than it truly is. And we have to remember, these are people who are sick. They’ve already had an event, but the 20% risk reduction assumes that, like 100% of people are going to have another event unless. But that’s not true. Like we can say that 92% of people in this sick old man group, 92% and nothing happened to them. Six and a half percent had some kind of event, regardless of whether or not they took placebo or wegovy. And just the only difference was, like, I Ragen Chastain 37:57 said that one and a half percent, yeah, and they also, there’s a lot of discussion in cardiovascular health circles about what the major adverse cardiovascular events are, and Novo Nordisk really picked just three of them, yeah. And the statistical significance even of that 1.5% was only for all three combined, not for each one individually, because there were so few incidents statistically, this is what they claimed. Is beyond ridiculous. And just like you said, That’s what I was taught, if somebody is trying to use relative risk, they’re trying to sell you something, and you need to be very cautious. Louise Adams 38:38 Totally. Yeah. So the study only met what they call like the primary outcome, which is that I had to mash all of the events together. That’s what when I hear mace, major adverts, cardiovascular event, I hear mash, which is like a mash up of all of the things that can go wrong, heart wise, because it takes too long for and it’s too expensive for studies to follow, like, to really figure out, like, heart attack versus stroke versus just disease regression. So they have to mash it all up into one kind of clump, and that’s this 1.5% Ragen Chastain 39:12 difference. So they couldn’t even confidently analyze in science, in statistic kind of terms, the secondary end points, like whether or not it reduced a heart attack, specifically, whether or not it reduced a stroke, specific, specifically, even whether or not weight loss had anything to do with it. So it really was like much to do about nothing. Yeah, and interestingly, Novo Nordisk found itself in an in a interesting place, because they found that the reduction in cardiovascular events, such as it was happened before much weight loss happened, and so they’d rather chug sewage than have to admit that the weight loss really wasn’t what it was about. But as you said, they desperately needed this, and they laid a trap, and the FDA and the. US. Government stepped right into it. The FDA approved the drug for adults using the real definition of adults with, quote, overweight and obesity, even though that wasn’t really who that this trial was for. So they got a much bigger market than they tested, which is what they wanted. Yep, and it worked perfectly. And then here Medicare and Medicaid, which, since the disaster of Fen Phen, Medicare, Part D has refused to cover weight loss drugs. And so they got them to wiggle and say, Okay, we’ll consider them if they are approved for other health reasons, as you alluded to, yeah. And so they needed that desperately. And so these glossed over that, but they were in a position where there it was clear to their data that Louise Adams 40:47 it wasn’t about the weight loss. So interesting, it’s quite telling when the whole study doesn’t actually bother to analyze like the amount of weight loss and the cardiovascular masher. But I’m going to read you an actual quote. The the effects occurred early, basically the effects of the protective wegovy stuff, the very small ones, happened before people really changed in size. So they say here, it suggests that more rapid treatment induced physiological changes beyond the magnitude of weight loss may have mediated at least part of the cardiovascular benefit here in English that’s admitting is that it’s not about weight loss this. I think what they found here is like what we’re talking about the beginning, like GLP ones, like protective cardio risk in diabetic people. We have to remember that two thirds of this old band sample had insulin resistance. So there is no proof that this has any kind of that the weight loss had anything to do with it. My suspicion is that it’s the insulin resistance kind of reduction that would have been predictive of this kind of small change, and they’re admitting it, but Ragen Chastain 42:01 yeah, it’s the whole thing is so frustrating, because they do also tell impacts on insulin resistance and impacts on blood sugar. And it’s, yes, it’s a mega dose of a diabetes drug. Nobody’s super surprised by that, but we probably could have gotten similar results if we didn’t give people this much of this drug, right? Their thing is, we’ve got to give you, got to get this mega dose approved, and so Louise Adams 42:23 be about weight loss. Yeah, they’re even saying some of these paid off obesity research is that this is proof that weight loss is good for health, yeah. Oh, but did you read the page? This is funny, like, when you think of this is the weight loss drug, and they’re trying to tell the whole world that weight loss is really healthy. You’d think that the weight loss would be like in the study, somewhere in a table and but it’s on page 36 of the supplementary index. Did you have a look at it? Ragen Chastain 42:53 I did. I went through the whole supplementary index, which was a font of interesting information. But go ahead, Louise Adams 43:00 it’s I knew, because you’re just like a nerd, like I am. They look at how many people have lost weight it’s interesting because they’re in the wegovy original trials. What was all over the media, but wow, 20% weight loss. Wegovy gives 20% weight loss in this child. 10% was like nine point something. Percent at week 104 was the average weight loss. So that’s half of what we’ve been told in the previous press releases about wegovy for weight loss. But then when you look in that table at four years, they only have data for 157 Ragen Chastain 43:37 people. Yeah, and but they put it out as a separate study, did you see that? Oh, yeah. They put it out as four year weight loss outcomes of semaglutide 2.4 and they said they maintained a 10% weight loss. But exactly like you said, they started out with almost 9000 people, and they ended up with 921 and then at the next weigh in 157 but they just put a graph up showing those people’s weight loss. I was like, this study should be called only people who are losing weight keep coming back to these weigh ins. But, yeah, no, they literally put it out as a four year outcome. And like, just in the like, in the figure itself, they have the attrition. And I guess they’re just hoping people don’t know how to read a figure. Louise Adams 44:20 But this is ridiculous. I was like, Ragen Chastain 44:22 because every time I try to I am aware that confirmation bias is a thing. I am aware that I can be impacted by it. So every time I approach one of these studies, I’m like, maybe this will be the one that proves me wrong. Yeah, maybe they really did maintain 10% weight loss. And then I look at figure one, and I’m like, oh, for the love of everything. Louise Adams 44:41 Come on. You’ve done it again, dudes. Oh, it’s ridiculous. It does support real world data, which I’ve been reading about, where I think after two years, according to American prescription rates, only 25% of Ragen Chastain 44:56 people are still taking this shit. Yeah, and you gotta ask. Ask yourself, why did they publish four year data about weight loss in the cardiovascular trial when they had a weight loss trial? How are those people doing? That’s pretty something I’d be curious about, like the fact that they chose women. Yeah, the 90 something percent women. And so first of all, they burst on the scene and they said this can create a 15 to 20% reduction in in body weight. But now we’re supposed to be happy with a 10% this is exactly what we’re supposed to notice that bit like, they just keep moving the good then it’ll be three to 5% like, really anything like, if an amount of weight that I could lose with a loofah and a haircut is now clinically meaningful and worth taking a drug that risks your life and quality of life. It’s so insidious, how they do it Louise Adams 45:47 so insidious, and it’s also really expensive to this kind of stuff. And I had a look at statin in terms of, if we’re looking at cardiovascular risk, statins, I kind of go to like the gold standards in reducing risk, in reducing risk in people who have had events before. So the same kind of population, a five year meta analysis showed that it reduced actual risk by 4% so that kind of shits all over the NoVo stuff, plus Saturn just keeps cheaper, and they don’t clog up your entire gastrointestinal wisdom. So I don’t know about you, but if I’m looking at risk, I would definitely be leaning on that less invasive, more effective side. But yeah, and it was, what did they say? So 26% of people who are in the wegovy group stopped taking it. Of course they did. Yeah, only three quarters ever managed to get up to the full strength, yes, but that’s telling us about the side effects of this. They Ragen Chastain 46:55 traded down as well. Sorry, sorry, you go. Yeah, no, I don’t have the exact number, but a significant number of people got up to 2.4 but then titrated right back down again. So that’s also concerning. Louise Adams 47:08 Yeah, yeah, it is. Plus the people who had the really adverse events leading to dropouts, which is like full stop and gastrointestinal stuff that isn’t described in very much detail at all in this study. Interestingly, Ragen Chastain 47:24 in this study, about 5% of people never made it off the non therapeutic point two, four milligram dose. So that’s the dose you’re supposed to take, just to get your body used to it. That’s not supposed to so if they couldn’t even get off the side effects of the non therapeutic dose like that’s a significant issue as well. These poor people haven’t even touched on just the age bracket. The people in this age bracket Louise Adams 47:53 dropping this much weight after having heart events, we know that balls and bones and all kinds of stuff is really important as we age. And I didn’t see anything written about that, Ragen Chastain 48:05 no, yeah, and trying to get Medicare coverage in the States, Medicare is predominantly people over 65 and there is a strong body of research that shows that weight is protective over 65 and then intentional weight loss leads to earlier mortality in that population. So aggressively trying to get this medication in the hands of that population is just not a responsible or ethical thing to do. As far as I can tell. I Louise Adams 48:33 don’t I haven’t seen any research they’ve provided to suggest any better outcomes for people on this drug. No, but this is the age of the press release and the age of the infomercial replacing the scientific method. Yeah, and like you said, people are falling for it because the FDA approved this on the basis of the Select study and the whole kind of global fluffing that took place for those three months after the press release, and then just three days ago in the UK, regulators approved wegovy for the additional reduction in cardiovascular risk. Yeah, and then, like, literally yesterday. So the 25th of July, Novo Nordisk released another press up, and they’re announcing the expectation that the European medical agency has adopted a positive opinion for an update of their wegovy for cardiovascular risk based on the Select trial. Ridiculous. Again, the 20% statistic is used. So the regulators are just falling into place and they as far as I can see, it is an indication only for people who have already had a cardiovascular event and for because that’s all it proved right? It did not prove that people have never had any heart issues, right? That this can prevent anything. It’s just that if you’re already sick, we can get this tiny reduction. But. It just opens the door bonovo, Nordisk and like the weight loss, drug cycling industry itself to pretend that this is good for health outcomes, and you can see them aiming for other kinds of low hanging fruit here, like sleep apnea and kidney stuff. Yeah, so it’s gonna happen, but I want to tell you about Australia, because Australia’s Pharmaceutical Benefits Scheme has so far resisted novos like attacks, and they’ve gone in, I think, three times, and they’ve brought in their paid off patient groups and their paid off obesity researchers and crowed and crowed about weight loss, but so far, they’ve been rebuffed. They got knocked back because the payback. That’s what it’s called, The Pharmaceutical Benefits Advisory Council. They said to them, we’ve calculated this would cost our public health, first, a billion dollars a year to subsidize your very expensive drugs, and you haven’t provided us any information on whether or not this will improve health beyond just the weight loss stuff. So they’re not giving up. They have now paid the payback, $270,000 to get a private, facilitated workshop, which is due to take place around now, and they’re going to bring in the Select trial results. So I’ll be very interested to see what’s going to happen when a company with more money than God turns up with their infomercial and and they all have the kind of global pressure and just see what they’re going to do there. Yeah, they care about health Ragen Chastain 51:34 Reagan. They do. I feel like they care about me. You know what this always? You know what this always makes me think of because we talk about it, but it’s like watching Purdue pharma all over again. Yep, absolutely everybody. They’re good for everything. They’re getting higher and higher dosages. It’s, it’s that playbook played out again. It’s, right, it’s Louise Adams 51:57 just a narrative that’s being shaped. And we, we are being played like violins, and there’s press releases left, right and center. But there’s a couple of things that there haven’t been press releases about, which I think we should note, because, like we said earlier, the second biggest group in the Select trial was Russia, right and they announced in November 2022 that they were going to be removing all of their ozempic from Russia, because they care about Russia’s health, right? So that’s because we all know that there’s been massive production problems and supply issues for their lucrative markets. So there’s this pattern that of taking things out of markets that are less lucrative, and popping them into particularly the US, because the US is the most lucrative market, so they’re pulling out of Russia. They are not going to have any more ozempic from December last year, and the Russians have approved basically bootleg versions of ozempic to be sold because they’ve just cracked it and got the sheets. And what do they do with their people with diabetes? It’s a second line drug for diabetes, but very effective for some people, and vital, and Ragen Chastain 53:13 for people who are contraindicated on other drugs, for people who couldn’t get their glycemic management, like it’s, I think people don’t understand those who weren’t able to get glycemic management until they started, GLP, one can’t just necessarily switch to another drug and have the same effect. That is really concerning, also the they’re titrated up. So it’s not like you can just stop and start and stop and start and be fine, like you’re constantly titrating up and down. If you do that, it’s really dangerous for folks what type two diabetes, to have this drug withdrawn so that they can sell it for more money for weight loss. In Louise Adams 53:46 other news, of Novo caring about the planet’s health, in which because South Africa was the third biggest group of people in select because they care about health, and they have announced that they’re pulling all of their pens out of the South African market. So they’ve had a contract with South Africa to give everyone with diabetes these pens. They’re very easy to administer for people with diabetes that they don’t require refrigeration, all that kind of stuff. So it’s really good for third world countries. They are not renewing their contract. They’re taking all of their pens, and that leaves 4 million South Africans with diabetes without pens. They’re encouraging to use vials. Yeah, Ragen Chastain 54:27 I knew that was coming. Yeah. What do Louise Adams 54:31 we know about vial? Yeah, it’s there’s refrigeration Ragen Chastain 54:36 issues, there’s sanitation issues, because you’re repeatedly drawing out of the same file. You have to have enough needles to always have a fresh needle, which most people aren’t going to be able to do. There’s all kinds of dangers that come along with vials that do not come Louise Adams 54:49 with those pens. Yeah, this is where we’re at with this company, and that’s why, you know, I will continue going down rabbit. I will continue going beyond the headlines, not believing the press releases, and being like a kind of sniffer dog to the weight loss drug cycling industry. And I know you feel the same way, and the stuff that you’re doing in your newsletters and in your workshops, like it’s just so important to take this kind of challenge to the narrative happening. Ragen Chastain 55:23 Likewise, I was on a panel, and I was really the only one espousing my viewpoint, which isn’t like different than most panels that I’m on, but they one of the guys was pretty aggressive, and he’s insinuated that I just wanted everything to fail, and I just said, I will take no pleasure when it’s time to say, I told you so. I don’t want them to be allowed to however many people they have to hurt, to finally have any action or have this withdrawn from the market. That’s not what I want at all. I want us to all look at the science like responsible adults who have training in this and say a 1.5% reduction for cis men who are white and 61.6 years old, means that’s who should get the drug, Louise Adams 56:09 not everybody. Yeah, and we need to look at the pricing issues of this, yeah, because they are hideously inflated. I think there’ll be another podcast coming soon on Bernie Sanders and his challenge to Novo Nordisk with Lars, the Novo Nordisk CEO, who is going to get grilled in a Senate committee. Not the first time, Noho have been grilled by Senate committees for price gouging. We something really is rotten in the state of Denmark. Yeah, and this is Ragen Chastain 56:41 a company. I always say this, we have to remember that they made their a fortune price gouging insulin in countries where they could do it. In particular in the United States, people died because they took this drug that’s patent had been sold to the government for $1 to make sure everyone would always have use of it. They bought that patent, and then they started to exponentially increase the price of a drug people need to live. So that’s who this company is. They will kill people for money and everything they do. I think we have to always view it from that lens. Louise Adams 57:16 That’s really true. Yeah, yeah, yeah. They’ve Ragen Chastain 57:19 lost, like, any kind of benefit of the doubt, or like, maybe they really do mean, but just don’t understand statistics at a high school level. No, this is a company that’s out to make a fortune, and they don’t care what it takes. They Louise Adams 57:30 don’t care. You know, I don’t know how many South African people with diabetes are going to die. I don’t know how many people in Russia are going to die. This kind of pattern is, it’s abhorrent, and to be able to continue to do science like this with impunity is really offensive. So many changes need to happen now I Ragen Chastain 57:51 actually put in a Freedom of Information request for all of the materials, transcripts and notes regarding the approval of wegovy for cardiovascular use. And I was told it was considered a complex request and it would take 18 to 24 months before I hear back, and that was a couple months after I put in the request. Louise Adams 58:11 Okay, good on you for putting in that request Ragen Chastain 58:15 so and at this point, I think 16 to 22 months out, I will have it, and I will write about it as soon as I get it. But I really want to know how they sat around and discuss this drug and if nobody raised their hand and said, Actually, relative risk reduction isn’t appropriate. Louise Adams 58:36 Yeah, yeah. Hey, maybe you could put out a press release. Ragen Chastain 58:39 Yeah, it’s a company announcement. Now it’s not a press release. You’re not marketing our drug. It’s a company announcement. Louise Adams 58:46 Okay, okay, I can’t wait for 16 to I think in between 16 to 24 months, I think we’re going to find some more stuff to talk about. Ragen Chastain 58:57 Probably, I can’t imagine. We won’t sadly, Louise Adams 59:01 thank you for doing everything that you do. And how can people find you? Where can people find you if they’re not already subscribed, Ragen Chastain 59:07 right back at you and I you can find my sub stack at weight and health care.com. Is right endlessly about all things, intersections of weight science, weight stigma, health and health care. Louise Adams 59:21 Awesome. Thank you for being on the planet, and thank you so much for this wonderful unpacking of all of this. Right Ragen Chastain 59:28 back at you. Thank you so much for having me, and thanks for all that you do. Louise Adams 59:35 I’m sliding in here just to add an Epilog to this episode. We opened with the Novo Nordisk sponsored obesity escape room PR exercise, with million dollar Donna being Speaker 1 59:48 so highly enthusiastic about the results of selected Louise Adams 59:52 in a slick 90 minute presentation, participants were fed a free dinner, plus a whole pile of speculation, because at the time the Select. Hadn’t even been published. But remember how confident Dr Carol and apovian Was that the cardiovascular risk reduction was because of weight loss, and how Donna admitted and we’ll need to do Speaker 1 1:00:11 the mediation analysis to see how much of this is being driven by weight loss and how much is being driven by Louise Adams 1:00:17 the drug itself. And yet, somehow, this really needed analysis has been conspicuously absent from any of the studies we’ve dissected today. But good news, this analysis was done, and I have found it. The results have been presented as a late breaking abstract in a five minute slot during the morning coffee break at the European Congress on obesity in Venice, Italy in May 2024 Yes, that’s the same obesity conference that the fast trackers were headed to, if anyone has listened to the previous podcast episode. But I suppose this research didn’t warrant a fancy dinner, a 90 minute glossy PowerPoint or a triumphant press release. The title of the paper is relevance of body weight and weight change on cardiovascular benefit with semaglutide a pre specified analysis of the Select trial. And the lead author is Dr John Deacon field from the UK. Intriguingly, this has not been published, which is weird, because Novo are usually lightning quick in publishing their favorable data, Ragen Chastain 1:01:28 as Reagan would say, show us the research, you cowards. So Louise Adams 1:01:33 in clinical trials, a pre specified analysis means that they have been planned and documented in the study protocol, so Novo had to do this analysis. They just couldn’t wiggle out of it. And of course, it’s really important information. In fact, it’s the smoking gun. The entire weight loss obesity industry rests on this claim that weight loss is good for health. It’s literally why the industry exists. So what did they find? Well, of course, I can’t give you much detail because there’s no study. We’ve only got this abstract to go off, but they have analyzed the relationship between change in body weight and waist circumference over the first 20 weeks of treatment with the risk of cardiovascular events that whole mace mash up that we were talking about earlier. So they analyzed cardiovascular events comparing people who were taking wegovy who had lost less than 5% or even gained weight. Yes, there were people on wegovy who gained weight during the Select trial, and they compared that with those who lost more than 5% I know it’s a weird comparison group, but without reading the paper, I have no way of knowing why they did this. So what did they find? Drum roll please. In the wegovy group, there were no differences in cardiovascular risk outcomes in those who did or didn’t lose more than 5% after 20 weeks. So they’ve done the analysis, and the risk reduction in select had nothing to do with weight change. So this was all about the drug itself. Where’s the press release? Where’s the media frenzy? Why so quiet on this Novo Nordisk? I couldn’t find a company announcement anywhere. This is why I need to keep doing this podcast and this work, my friends, because this company, Novo Nordisk, are really shaping the narrative in profit friendly ways, whilst sidelining and virtually ignoring really important information which could actually help human health. It’s un bloody believable. Rest assured, I’m going to be keeping an eagle eye out for this paper when it gets published, and I’m going to talk about it loudly, but with no escape room necessary. A big, huge thank you again for my amazing guest, Reagan Chastain. You can find her at dances with fat.org That’s the website on Instagram at Reagan Chastain, and please join her sub stack, because there are some amazing newsletters. She just does this sort of stuff all the time. So it’s weight and health care, dot sub stack.com. Reagan also does monthly workshops and like, I don’t know where she gets her energy. She’s amazing. Okay, my friends, that’s it for now. I am going to be back with more steaming diet culture bullshit at a later date, and I’m sorry I can’t be more predictable with my upcoming rants, but please know that I’m here, I am annoyed, and I’m ready to go straight back down the anti diet rabbit hole. Stay strong diet culture dropouts, and don’t forget to subscribe so you don’t miss any new episodes. I look forward to speaking again soon. In the meantime, trust your body, think critically, push back against diet culture untrap from the crap you. Transcribed by https://otter.ai