The FDA have approved Novo Nordisk’s weight loss drugs, Saxenda and Wegovy, for use in teenagers. But how effective are they, and what are the potential consequences of normalising the use of injectable drugs for weight loss in kids as young as 12? Join Louise as she takes us through the Novo Nordisk funded clinical trials. Are these drugs really the magic pill they’re touted to be? Or are we taking unjustified risks in the name of fat eradication?
Show Transcript
Unknown Speaker 0:12
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 to spit-spo? Are you ready to hurl if you hear one more weight loss tip? Are you ready to be mad, loud and proud? Well, you’ve come to the right place. Let’s get all fired up. Hello, diet culture dropouts. Exciting news. I’m going to be back every week from now on, and the all fired up format is going to change a little bit. I’m going to release a new podcast episode every week. And most of the time, it’s going to be me ranting on a different diet culture topic. And I’m going to bring in a guest roughly once a month to augment me rant. The all fired up podcast is brought to you by my brand new revamped version of the untrapped online program, introducing the untrapped Academy. I’m so excited to tell you about this. My new look. untrapped Academy is no longer an online module based program. What it is now is an extremely affordable membership subscription, bringing you new speakers every month, a skills training session to bring anti diet ideas to life and a support group. There’s also a wonderful private Facebook community, which has been running since 2017, and has hundreds of really friendly anti dieters ready to welcome and support you. So is the trapped Academy for Well, if you’ve struggled with food, the body exercise and if you’ve had a gut full of diet cultures bullshit, this is for you. If you’re new to the world of anti dieting, and looking for information skills, training and support, this is for you. Or if you’re a seasoned anti Dieter looking to keep up with new developments in the anti diet world. This is for you, as well as regular live talks, skills training sessions and the support group. The untrapped Academy houses an ever growing online video library where everything is body positive, fat, positive and weight inclusive. And to kick things off, I’ve just finished uploading 12 Incredible anti diet speaker talks into the academy. These are all taken from body talks, which is a two day anti diet Feastival, which I’ve just finished running over the weekend of international no diet day. Body talks had unbelievable lineup of speakers. I’m talking we had Dianne Bondy, Christy Harrison, Dr. Sabrina Strings, Ragen Chastain, Fiona Sutherland, Sofie Hagen, Chrissy King, E-K Daufin, Lacey-Jade Christie, Ashlea Gillon, Dr. Fiona, er and Megan Crabbe, can you believe that lineup, so all of these uplifting talks are waiting for you in the untrapped Academy right now. And I’ll keep adding to the video library every month. The untrapped Academy is the ultimate way to learn anti dieting from many, many wonderful teachers. And it’s a complete bargain. And I have an amazing launch offer. So for the first 50 People who sign up and become founding members, the membership is just one Aussie dollar for the first month. And then after that, it’ll be 15 Aussie dollars every month. Once I hit 50 founding members, the price is going to go up. So once we hit that number, the price will be 25 of Aussie dollars a month for the platinum level membership.
Unknown Speaker 4:14
If you become one of our founders, you’ll always pay only 15 Aussie bucks a month to say thank you for believing in it. I’m so excited to get the ball rolling and I really hope you’ll consider coming along for the ride. And of course if you’ve got maybe clients, patients, friends, family members, colleagues, literally anyone you think might benefit from becoming part of our untrapped Academy and becoming a founding member. Let them know about us. So head over to untrapped.com.au To find out more. I can’t wait to see you there.
Unknown Speaker 4:53
Now before we get started with today’s awesome show, just a little reminder if you love all fired up and you don’t want to be
Unknown Speaker 5:00
Have any of the podcast eps as they drop every single week from now on, make sure you subscribe. You can do that at Spotify or wherever you get your podcast from. And if you’re feeling really generous, please leave a five star rating and review because that really helps get the word out. So let the show begin. Well, as you know, over the last two episodes, we’ve been really deep diving into the terribly dodgy world of weight loss drugs. And I encourage you if you haven’t already, listen to the previous two episodes on weight loss drugs in adults, please go do so now before you listen to today’s episode. Doing this will help you get a sense of Big Pharma in general and the massive havoc that weight loss drugs have historically caused, as well as really helping us to understand the length to which pharmaceutical company Novo Nordisk are going to in order to dominate the next generation of weight loss drugs, their GLP one agonists Saxenda and Wegovy it is frightening stuff. And yep, here we go again, because literally about five minutes after the last episode dropped on Novo Nordisk mission to medicate the planet with its weight loss drugs, the FDA in America approved wegovy for use in teenagers, What a shitty Christmas present for us all. And then just a few days later, well, on Eighth of January 2023, the American Association of Pediatrics released new guidelines for the quote unquote management of obesity in kids and these coincidently heavily encourage the use of drugs in teenagers. I am smelling a rat, my friends and thankfully, so do many other fierce and furious anti diet advocates. The wonderful Ragen Chastain has already said some awesome stuff about this on her newsletters. So please, I’m advising you all, to head straight there to dances with fat.org Sign up to Ragen’s newsletters and read because as you’ve heard from the last two episodes, Ragen is basically a genius at unpacking all of the reasons the stranglehold Big Pharma have over medicine at the moment is wrong, and you need to read it. So what am I going to do? What am I going to add to this conversation? Well, as you might have noticed, I have a bit of a major nerd need to talk in detail about weight loss drug trials. So we can dig underneath all of these industry sponsored headlines, and understand the actual science to know what we know and importantly, what we just don’t know. So today, what I thought I’d do is give you all a little overview of the clinical trials for novo’s weight loss, drugs, Saxenda and wegovy. Today’s episode comes with a massive trigger warning, we’re going to be discussing weight loss numbers, BMI as weight and eating disorders. We’ll also be talking in detail about suicidality and suicide in teenagers. So please look after yourself and give this one a miss. If these are topics which are going to upset you, there is absolute buttload of the word obesity in this episode as well. And I do apologize for that. It’s simply because this is the language of these fat phobic reviews. So to the first point, I really need to note the accelerating speed with which novos drugs are being approved, and getting on the market to our kids. So for example, the saxenda clinical trial on teenagers was published in the New England Journal of Medicine in May 2020. And it got FDA approval for use in 12 to 17 year olds seven months later. So in December 2020, the clinical trial on wegovy, and kids was published in the same journal on the 15th of December 2022. And then eight days later, on the 23rd of December, the FDA approved it for use in teenagers. So between saxenda and wegovy. There’s been a massive escalation in the speed of FDA approval from seven months down to eight days. And of course, we can’t help but be reminded of novos premature ejaculation of wegovy for adults. As you recall, they were publicly bragging about performing the quickest launch ever, after they had paid us 100 million bucks to put the FDA approval process on quote unquote fast track. And in the adult population. within 72 hours of FDA approval. They had all of their salesmen in the field funking their drugs into pharmacies quicker than a speeding bullet. It’s bad enough that this company, Novo Nordisk, who are very aware of their shrinking insulin market as the lawsuits are catching up, and who are trying desperately to stay ahead of their rival
Unknown Speaker 10:00
slash lock step buddies Eli Lilly as they launched their own GLP one agonist weight loss drug are able to Speedy Gonzalez new weight loss drugs to adults live alone for kids. Have we learned anything? Rushing weight loss interventions before the long term effects and harms become apparent is bad science for adults and just horrific for teenagers. So to the papers themselves, the first thing we need to talk about is who funded these trials? Well, like the clinical trials in adults, both of them were designed paid for and overseen by Novo Nordisk. And again, like the adult trials, the papers aren’t telling us anything about how their recruitment process worked. All we know is that these kids arrived from mysterious Novo Nordisk study centers from all over the world, mostly from centers in the USA and Russia, but also Belgium, UK, Mexico, Sweden, Austria, Croatia and Ireland. It’s just really weird to read scientific papers, and have literally no knowledge about how the subjects were recruited. Like it’s literally unheard of, unless you’re reading a Novo Nordisk research paper justification. Friends, it is a dark day, when I’m here talking about putting children on weight loss drugs. Over the years, I’ve talked about some hideous things which have been done to kids in the name of upholding fat eradication, for example, the Fast Track trial, which sentence kids to an entire year of semi starvation in the form of intermittent fasting. But this Novo Nordisk drug thing, it just takes things to a whole new level, we’re talking about putting teenagers throwing kids on double doses of GLP one diabetes drugs, which means subjecting them to daily or weekly injections, which will make them feel really sick and have a whole cascade of other potential and as yet unknown long term effects, including an increased risk of gallstones, potential thyroid cancer, potential pancreatic cancer, but exhausting their beta cells. So you think that we’d get like some very, very strong evidence of this risk teenage fatness, in order to justify even thinking about taking these kinds of extreme measures? Like as far as I’m concerned, there needs to be a very straight line from fatness to devastating adult illness to even consider doing this. So something like well, you know, 100 clinical trials have absolutely shown clearly, that being fat as a child directly causes you to become a zombie at age 40. And we have proof from another 100 clinical trials that weight loss will prevent said zombification. Only then can we even start to consider the crazy kind of interventions like injecting kids with drugs. So do these research papers begin with a lengthy and scientifically robust discussion of why we’re considering this? No. Both papers devote one a throwaway sentence to this effect send a paper says quote, obesity is a chronic and progressive disease that affects approximately 107 point 7 million children and adolescents worldwide and is associated with multiple coexisting conditions and complications. And quote, just one lonely reference is provided to support this sweeping statement that being fat as a child is associated with multiple conditions and complications. This is a 2017 clinical practice guideline written by an endocrinologist and it focuses mostly on how kids and teenagers should be quote treated for their condition. At various points. The paper does discuss the correlation between various health issues in adulthood and being larger as a as a child. But the research is so full of holes, it’s a souffle. There’s no accounting for multiple compounds like socioeconomic status, race, weight, stigma, etc. That this is just always the convenient scapegoat. It’s so clumsy. There’s no compelling smoking gun, no straight line, in my opinion, absolutely nowhere near enough evidence to show that injecting kids with drugs is a good idea. The wegovy paper also presents just one sentence to justify this invasive intervention. It says quote among children and adolescents with obesity brackets, a chronic progressive disease and bracket. Other conditions such as dysglycemia hypertension, dyslipidemia, non alcoholic, fatty liver disease, and obstructive sleep apnea might develop alongside impairment in mental health and quality of life. Note the other conditions may develop. The wegovy paper gives us three references to backup this claim. The first of them is not a research paper. It’s a physician statement from a pharmaceutical industry.
Unknown Speaker 15:00
prefunded obesity organization. The second is an article from 2005, which actually admits, quote, the extent to which obesity present or incident during adolescence has enduring effects on the contributors to the metabolic syndrome, either independent of or dependent on central adiposity remains to be clarified, and quote, this is basically admitting that they really don’t know. The third reference is about mental health, which is written by a nurse and a psychiatrist from Virginia Commonwealth University. And honestly, it’s one of the most fat phobic papers I’ve ever read. And that is saying something that contains such nuggets as following quote, childhood obesity is associated with behavior problems when girls start school and quote,
Unknown Speaker 15:54
incredibly, his paper never discusses weight stigma, or other kinds of things like the social determinants of mental health myopically focusing on this crazy idea that it’s being fat as a kid, which is leading to mental health issues. It’s totally circular. Please, no one read this article without being in a full hazmat suit. So just to recap, neither of these Novo Nordisk sponsored papers felt the need to really try to pretend to scientifically justify a massive uptick in medicalizing children. This is truly frightening. Let’s talk about the sample sizes. The next thing to note about the Novo Nordisk funded teenage weight loss drug trials is that they use really, really tiny sample, the adult trials had 1000s of people enrolled, but for the teenagers. So for example, the SEC standard trial only had 250 kids, and wegovy was tiny, which is 201 children. Part of me likes to think this is because parents are really reluctant to do this to their kids. But the most cynical part of me knows that it’s pretty much obvious that it’s cheaper for Novo to run tiny clinical trials to justify expanding their market. And for them, the hard grunt work has already been done, because they’ve already got FDA approval for the use of their drugs in adults. Once a drug is over that hurdle, a case for market expansion is much easier. Of course, the downside of running tiny trials like this is that it just has not been exposed to many kids. So we don’t really have an idea of what will happen when these drugs are unleashed on potentially millions of teenagers, like the adult child, the kids in these experiments were mostly white 84% in the sex center trial and 79% in wegovy. Most were girls 56% in sex center and 62%. In wegovy, the average age of the kids in the sex center child was 14 and a half. And in the wegovy trial, they were 15. And the average weight of the kids in the sex ended child was 99 kilos and in wegovy 107 kilos. So kids who were in their 95th percentile range of weight for their age, were eligible to enroll. Overall, the kids are in quite good health. Although the saxenda paper claims that 25% of them had dysglycemia, which is a broad term, meaning either hypo or hyper, too much or too little blood sugar. And this is not the same as diabetes. generally healthy people can have display Samia occasionally. And puberty is a time of extreme fluctuations on measures like this. So it’s really impossible to interpret what this actually meant in terms of the kids health. In the wegovy trial. They report that 4% had type two diabetes, and 13% were hypertensive. In this accent, a trial Novo allocated equal numbers to the SEC sender versus placebo group. So 125 Kids got sick sender, and 126 bucks SIBO. In the wegovy trial, they went back to their more standard two to one allocation. So there was double the amount in the wegovy group to placebo. 134 got wegovy and 67. Got placebo. Now, a note on unequal randomization. This is never explained in any of the papers and this happened in the adult papers as well. There are no rationales given as to why they did unequal allocation. I have mentioned a few times that I have feelings about novos habit of two to one randomization, but they were too boring and too statistical to share. But I do think we need to touch on it. And it’s my podcast, so we’re going to do it. So in science, one to one randomization is a key element to ensure that the playing field is level when science is testing ideas, especially when we’re
Unknown Speaker 20:00
testing the idea of whether doing nothing is better than doing an intervention. One to One randomization is the gold standard. All other things being equal from two groups of people with similar characteristics, we can give the intervention and then compare the results. But when we double the number of people getting the treatment, there’s consequences when you’re doing something methodologically. That’s a bit odd. There’s an expectation that you’ll explain why, but Novo have not. I’ve been reading in depth about the ethics of two to one allocations. And basically in the literature, there’s a few reasons why researchers might choose this. For example, ethical reasons I a people think it’s better to give the treatment than to do nothing. But of course, this presupposes that the treatment is better than doing nothing, which is meant to be the reason the experiment is being done in the first place. This kind of reasoning just exposes the researchers bias towards their preferred outcome. It’s a huge nono in science. Improving recruitment is another reason often cited to do this. But there’s actually no evidence that recruitment in clinical trials is more effective if allocation numbers to the intervention group are higher. And of course, this once again reveals the researchers bias towards their own hypothesis as ethicist pay and Kimmelman stated in their excellent 2014 paper, the questionable use of unequal allocation in confirmatory trials, quote, equal allocation is the most efficient approach. It offers the best risk benefit ratio for subjects. it incentivizes conscientious informed consent discussions, and it minimizes certain threats to internal validity.
Unknown Speaker 21:42
Back to the teen drug trials, both of them sat center and wegovy included a 12 week running period where the kids had to undertake a lifestyle intervention. Even though one of the criteria for entering the study was a previous inadequate response to lifestyle interventions. Go figure. The running period included repeated meetings with a dietitian and being told to exercise for one hour a day in the sex no child but the adult those that then does that three milligrams and into a daily injections for 56 weeks. Kids in the wegovy child get weekly injections of the 2.4 milligram adult dose for 68 weeks. Additionally, the sex center trial had a 26 week follow up period where they were off the sex Emma wegovy trial had a 68 week intervention and then a seven week follow up period where the kids were off wegovy. So what happened? Well, 20% of the SEC send the kids dropped out. Only 103 of the 125 original kids are able to tolerate the full three milligram dose because of the nasty side effects. So we have to keep in mind that we we never really know what happened to 20% of these kids out of their original 134 wegovy kids only 120 was still taking the drugs by the end, so about 10% couldn’t handle it. What happened with weight loss and reggae? Well, on average, in the saxenda group, the kids lost 2.7 kilos. And then after they stopped taking it, they quickly regained weight, even though they were still going through that intensive lifestyle counseling. So 26 weeks after they finished sex center, they weighed on average 1.7 kilos more than when they started. Clearly, there’s nothing to really shout about here are a vulnerable teenager who weighs on average 99 kilos, this is not a huge result after enduring daily injections, daily exercise for one hour and this healthy lifestyle counseling. Well, what about health benefits? Were there any? Isn’t that what we all care about? Well, in this extender trial at week 56. After all of that injecting and exercise and dieting, there was exactly zero difference between the sex and the kids and placebo on measures of glycemic and Cardiometabolic variables or in the overall what they call weight related quality of life. What a big nothing burger right? In the wegovy trial. Over the course of 68 weeks, the kids lost on average 15 kilos, which was very similar to the weight loss reported in adult studies. 73% of the kids lost 5% of weight. We have to remember that this means that 27% of kids like more than a quarter didn’t even lose 5% of weight on wegovy 62% of kids lost 10% 53% Lost 15% and 37% lost about 20% of their weight. Over the course of the trial. The percentage change in BMI was 16.1%. But then after they stopped taking the drug
Unknown Speaker 25:00
Seven weeks later, they had put on 3% of that 16% loss. So these percentage differences I’m telling you about this because they’re the only solid numbers given to us as readers in relation to what actually happened to the kids after they stopped taking wegovy. So these are the only reported results after in between week 68. And then seven weeks later, there is a graph in the supplementary, where you can see that the rate of weight loss for wegovy kids really slowed down by about 28 weeks in. And this graph, of course stops at week 68, not weighed 75.
Unknown Speaker 25:39
And the same graph shows weight stability in the placebo group. So of course, the same things that I spoke about in the adult paper applies. Because these papers are much more like advertorials than statistics. They’re really only reporting very broad steps like percentage weight loss, it’s very hard to get much of a sense of what happened inside these groups. Like Were there a lot of outliers, like people who had unusual experiences like a high rate of weight loss. And is there a risk that we have skewed the results? We have to remember, this is not a very big group of kids. And you know, put a couple of kids in there with massive results and the averages can really change. They did mention that one child who stopped taking wegovy was giving was given phentermine. But apparently this kid was still counted as a wegovy win. This is just a clue to what might be going on behind the scenes here. The authors don’t discuss the negative physical impact of weight cycling, which has been linked to death and all of the health issues normally blamed on weight itself. And they totally ignore the psychological impact of this experience on the kids. More on this in a minute. In the SEC send a paper with the terrible weight loss results, they are cheeky enough to state that the weight regain reinforces, quote, the concept that obesity is a chronic disease that requires continued treatment of slaves. I need to mention too, that scientifically, the wegovy trial was a statistical Limp Biscuit. In a late stage clinical trial, the researchers look for what’s called primary endpoints. So in the wegovy trial, the primary endpoint was percentage change in BMI in between week one to week 68. And the secondary endpoint was a weight loss of at least 5%. At week 68. The wegovy trial also investigated 13 secondary supportive and exploratory endpoints. So things like blood pressure, and BMI and percentage weightless, all of that kind of stuff. And here’s what’s interesting. Bearing in the statistical analysis section, the author’s admit that statistical analysis of their secondary supportive endpoints and exploratory endpoints were not controlled for multiplicity, please bear with me, in statistics, not controlling for multiplicity risks making type one errors. And that basically means finding what looks like a significant effect when really there isn’t one. So according to a 2016 article in the International Journal of Epidemiology, in cases where relevant adjustments and not carried out a clear explanation should be provided and study results have to be interpreted with caution. Now I studied all the NoVo child protocols and gone over the supplementary material with a fine tooth comb. And nowhere can I find any explanation of why with all of their money and power and unlimited like people, they haven’t bothered to do this really important statistical step. They really should have considered this and plan to adjust it. So why didn’t they basically it effectively means that sort of scientifically, we can’t take any of the wegovy trial findings seriously, apart from the first two, like the percentage change in BMI from week one, 268 and reduction in weight by at least 5%. All of their other findings, all 13 have to be treated with a really high degree of suspicion. But these are the ones discussed at length in the paper and in media releases. Absolutely statistical skullduggery, it’s unacceptable. Even though there should show of a trial is a statistical biscuit, and we shouldn’t interpret anything other than the original endpoint. The paper still claims that wegovy led to improvements in cardio metabolic factors, including blood sugar levels, cholesterol, low density lipoprotein cholesterol, triglycerides, and il T levels. And of course, what they don’t mention is that on average, attains were pretty much in the healthy ranges for all of these factors. Even before the trial began, there were only two very small anomalies, but in teens, these anomalies are quite unreliable measures to start with because of puberty. So what an overstatement to claim that we have an improvement in cardio
Unknown Speaker 30:00
metabolic health how very cheeky I raged about this on my last episode on weight loss drugs in adults, the same like absolutely bolshie reporting of health improvements happen happening in the kids paper. They did that in the adult paper as well. Once again, we have a group of pretty much healthy people, the only differentiating characteristic is size and weight, and the authors are consistently confabulating. This with health is out raters. Now remember that the wegovy paper did state that at the beginning of the child, 13% of the kids had hypertension and 4% had type two diabetes. Well, there’s no follow up on these kids. So we have to assume that by the end of the trial, these kids were still hypertensive, and still meeting diagnostic markers for type two diabetes, no dramatic health risks in remission anywhere to be found. So for all of these weight loss, and so called health improvements, of course, there were side effects to taking double doses of adult Diabetes drugs. 89% of the SEC said their kids reported them and the most common were nausea, diarrhea, diarrhea and vomiting. 26 kids in the saxenda group had hypoglycemic episodes and one developed pancreatitis 13 saxenda Kids dropped out because of the side effects including vomiting, nausea, upper abdominal pain, abdominal discomfort, pancreatitis retching, injection site pain, elevated pancreatic enzymes and depression
Unknown Speaker 31:31
17 79% of the wegovy kids had a whopping 792 adverse effects, again, like the most common were nausea, vomiting and diarrhea. 11% of the wegovy kids had severe side effects, and most common again was severe gastro, and 5% of those dropped out because it was so severe. Worryingly, the wegovy kids showed increased levels of lipase and amylase and those are measures of potential pancreatic injury. Five kids developed gall stones. And similar to the adult child, the kid’s heart rates increased by an average of 1.2 beats per minute with wegovy. What about mental health? The paper stated that 13 Kids in the SEC sender group had, quote unquote, events related to psychiatric disorders, no further info is offered in the paper. But in the supplementary index, these events are listed. And it shows that two of the kids taking sex offender developed eating disorders during the trial. Now, I don’t know about you, but I think that teenagers developing eating disorders during a weight loss drug trial, it’s worth at least mentioning in the paper itself. From what I can gather all the kids in this child who developed mental health problems, including eating disorders were left in, they were not removed, I have almost no words, and the mental health side of things gets worse, much worse and trigger warning. I’m about to discuss suicide of a teenager and suicide attempts in detail. So please skip the next few minutes if this is upsetting for you.
Unknown Speaker 33:06
About 11 months into the sex ended trial, a 17 year old black male committed suicide. There were two more attempted suicides during the 26 week follow up period. One was a 14 year old male from the SEC standard treatment group, and the other was from the control group, and no details about this teenagers age or gender were provided. The paper really glosses over these tragic events, saying that both the site investigators and sponsor deemed these three events as unlikely to be related to the trial treatment. The data monitoring committee reviewed suicide related events during the trial and recommended that the trial continue in accordance with the protocol.
Unknown Speaker 33:48
I managed to find what looks to be an external review paper on this by someone called Julie golden. This details that the investigators had tried to contact the family of the boy whose suicide ID they had received no response from them. So no one knew the true circumstances of this suicide. Dalton concluded that there was a temporal relationship to liraglutide so a causal relationship cannot be completely dismissed. Now this does not match the claim made in the paper that the suicide quote was assessed by the investigator is unlikely to be related to the child treatment. Good Lord. The suicide attempt by the 14 year old male in the sex Ender group happened in week 69 of the trial. This child had lost 4.9% of their weight in week one, but by week 64 had gained it back and at that point was 11% above his starting weight. This child had actually stopped taking sex ended two months prior to the attempt, but had still been involved in the child and had been prescribed an antidepressant three months before the suicide attempt is clear that antidepressants are being viewed as the potential trigger
Unknown Speaker 35:00
For the suicide attempt in this paper, the supplementary index reports that this child had a history of depression. Even though this was supposed to be an exclusion from the experiment. This child was not taken off the trial, in spite of the suicide attempt, and in spite of his psychiatrist then putting him on further serious psychiatric medication review until the golden concluded that this suicide attempt was unlikely to be related to the investigational drug. Although the relationship of the event to his participation in this weight loss child cannot be excluded. That’s what I think too. And I have more to say about that in just a moment. The third teenager who attempted suicide was from the placebo group. This was the heaviest team with a BMI above 50. And of course, experience no weight loss during the trial. Apparently, this person had been diagnosed with insomnia and depression during the trial, which they noted as, quote unquote non serious, but they will put on an antidepressant one month before the attempt. This kid was also left in the child after the suicide attempt on the 480/4 day. I couldn’t find any more details on this and Julie Goldin did not mention this attempt in her review. I want to say something about these awful tragic events, in spite of the author’s apparent certainty that saxenda had nothing to do with them. Nowhere in the paper was the impact of being a teenager in a weight loss child discussed or raised as a potential trigger for suicidality. We need to think about this, the child who died and lost 12% of body weight at week 34, but was regaining and had put on a third of that lost weight at the last weigh in in week 46. Before he died, a potential issue of the psychological impact of weight regain was not raised anywhere in the paper. And even in the absence of any communication from the family. This possibility should have been raised the child in the SEC send a group who attempted suicide. I’ve been enrolled in a weight loss drug trial for almost 16 months, during which time he becomes significantly heavier than his starting weight. The child from the control group suicide attempt also happened at the 16 month mark 16 months of constant weight focus, with no weight loss, when we consider that these kids are being brought into Novo Nordisk trial centers to be weighed, measured, grilled about their lifestyle habits and food at multiple points during their adolescence. And when we consider that the great white hope of lasting weight loss had not happened for them, what is the likely psychological impact of this isn’t so hard to imagine that the weight loss focus played at least some kind of role here? If we don’t ask these questions, we’re doing harm. The wegovy paper reports that there were no deaths. But perhaps they learned something from the SEC center trial. As this time, there’s no table in the supplementary index documenting in detail mental health issues. So we just have no idea if anyone in this child developed an eating disorder, or another serious mental illness in terms of impact on general mental health is that in spite of being statistically unable to state such things, the wegovy paper says that, quote, wegovy was associated with improvements in the impact of weight on quality of life, kids total score, and the physical comfort domain score at week 68. Now, this measure the impact of weight on quality of life. This is not a measure of the impact of weight on quality of life. It’s measuring the impact of weight stigma on kids quality of life. And because it was developed by weight centric researchers who can’t help it define body size as a disease, they just can’t see past their own ourselves. This sentence gives the impression that the weight loss drug trial improved the kids mental health. But what they don’t mention is that the kids scores on this measure were already pretty good before the trial started, and the total change after all of that injecting and exercising was an unimpressive five points. So in summary for the sex ed a child for adolescents, there was a small number of kids who experienced very little weight loss, rapid weight regain zero health benefits, significant side effects, the development of two eating disorders to suicide attempts and one death by suicide. My advice would be run don’t walk as far away from this as possible. And in the wegovy, trialing kids, we got a statistical nothing burger. We have a very small number of kids followed for a very short period of time, experienced average weight loss of about 15 kilos, only while they kept taking it. They tried to hide it but there’s clear evidence of a quick regain once the kids stopped taking it. There were significant gastro side effects for most kids and about 10% had really severe side effects including gall stones pancreatitis
Unknown Speaker 40:00
edits and severe gastro. There was no evidence of significant health improvement and miniscule improvements that were reported in both psychological and physical health and nothing more than smoke and mirrors. And the avoidance of any long term follow up stinks. There’s warning signs here, but also not enough information given in many areas. My advice for wegovy Be very, very wary of this steer clear by a 50 foot pole and don’t be afraid to use it if approached by an obesity Management Center. Our kids deserve more. Let’s not forget that both wegovy and SEC center carry blackbox warning. And we don’t know anything about all sorts of things like the long term impact of hammering our beta cells, let alone the risk of thyroid and pancreatic cancer. I also have to mention the prohibitive expense of this drug for families. If you can’t afford to take this drug for life don’t even do it. Novo Nordisk are in a massive rush because they’re hungry for profits and they’re busily crafting the narrative of urgency. And meanwhile, we’re forgetting that when it comes to health, we need to first do no harm. Okay, everyone, I am spent and I need a shower. Thank you for listening everyone. And please make sure you stay tuned for next week when I’ll be coming back and taking a walk down memory lane with Jenny Craig. Take care of yourselves and remember, trust your body and critically push back against diet, culture and trap from the crap
Transcribed by https://otter.ai
Resources
Resources
Saxenda clinical trial paper
The one lonely reference about the health consequences of being fat as a child
Wegovy clinical trial paper
The World Obesity Federation’s position statement on being a fat child (should be flagged as an advertorial for Bigpharma)
2005 endocrinologist’s guideline paper on ‘treating’ fat children
An enormously fatphobic take on fat children through the lens of psychiatry
‘The questionable use of unequal allocation in confirmatory trials | Neurology’
2016 statistics paper on multiplicity
FDA external review paper by Julie Golden
