AT A GLANCE…
- GLP-1 drugs continue to hit the headlines, with United Health Group CEO Andrew Witty weighing in on their benefit and usage.
- Pregnancy risks of GLP-1 meds – very low likelihood, though currently unknown beyond animal studies.
- Teledoc strides into GLP-1 space; and Ro founder Zachariah Reitano publishes a long piece on the scientific basis of obesity management with respect to GLP-1 medications.
- Bariatric surgery reviewed for treatment of severe obesity in adolescents.
- Bariatric surgery is beneficial for non-alcoholic steatohepatitis, or NASH – a precursor to end-stage liver disease; with NASH predicted to affect 27 million people in the USA by 2030.
EVENTS
- A busy week for health technology and investor folks, with the annual HIMSS conference in snowy Chicago, and the Health Evolution Summit in the far sunnier setting of Dana Point, California.
NEWS
- The sub-headline from David Wainer at The Wall Street Journal reads ‘…Strong sales of obesity-diabetes drugs known as GLP-1s could affect insurance companies’ financial results.’ He continues to pose the question ‘…What do insurers, who ultimately foot the bill, think about this new revolution in the treatment of obesity? If this class of drugs can truly surpass $100 billion in annual sales, as many analysts expect, insurers (and ultimately employers and the government) will have to foot the bill.’ As with any new drug, device or intervention, it is key to determine the value in terms of clinical outcomes, for whom such value is derived, and over what time period. Akin to United Health Group CEO Sir Andrew Witty’s response during a recent UHG earnings call ‘…We need to really be clear about which patients really do benefit from these medicines and make sure we properly understand how they’re going to use those medicines.’ It is helpful to know that Mr. Witty grew up in the United Kingdom and was a past advisor to the National Health Service, which is certainly more stringent on determining and applying the value and cost-effectiveness of novel interventions, than the United States.
- But there is also scare-mongering here – JPMorgan analysts Lisa Gill is quoted to suggest that the medications ‘…cost $6,000 a month’, which is way off in my estimation; routine costs today for Ozempic are in the range of $850 to $1,300 per month – still significant!
- I am surprised that there is no reporting of the immense value of GLP-1 and additional treatment modalities such as bariatric surgery, for people with obesity – just a 10% reduction in total weight can eliminate the need for many people for blood pressure and diabetes medications; enable them to be more active; and even allow them to be more productive in their chosen employment.
- Let’s try to do the right thing and align the reporting of costs of novel interventions with the value creation and disease remission, as well as disease mitigation, and longer, happier lives that result. This can enable and assist the over 40% of the US population that suffer from the multiple downstream effects of overweight and obesity.
- Julia Belluz writes in Vox on a topic that I have been pondering for some time: on the ‘…pregnancy risks of Ozempic and Wegovy…’ and that the ‘…drugs are linked to birth defects in animal studies.’ More specifically, ‘…studies in rats, rabbits, and monkeys, which were treated with the injectable drug and had higher rates of miscarriage…’ such that Ozempic and Wegovy should be discontinued at least two months prior to pregnancy.
- In my clinical practice, we strongly advised patients to avoid getting pregnant for at least one year after bariatric surgery; due to the degree of weight loss that occurs in the early post-operative period, which does not enable the calorific needs of a growing fetus to be met. Most of my patients did heed the advice, but there were a small handful that did inadvertently get pregnant; we had to manage them carefully through the gestation period – which was tough, and intense.
- A researcher is quoted anonymously in the article ‘…Given the majority of people accessing these medications are women, and a significant portion will be of childbearing age, this needs more attention.’ We all hope that Joseph Ross, a Yale professor is not proven right in that ‘…we could end up in an awful mess – pregnancies ending in miscarriage or neonates born with birth defects…’
- A key question is whether the higher rates of miscarriage in the laboratory animals are a consequence of the weight loss that occurs, as could have happened in my bariatric surgery patients, or another effect that is independent of weight loss, such as issues with placental formation, or placental blood flow, that have the potential to be more serious. To try to answer this question, Novo Nordisk has set up a registry of people exposed to Wegovy who get pregnant; with the first reports in 2027… wow – just imagine the numbers of women of child-bearing age who will have been on a GLP-1 agonist four years from now!
- I have do not have an answer to the current situation, though would be very cautious in anyone who was considering pregnancy whilst on a GLP-1 medication; and further, could there be any impact on sperm count and quality?
- It was going to happen… the most well-known telehealth company, Teladoc, announced this week it is ‘…expanding its telehealth services to include prescribing obesity drugs such as Novo Nordisk’s Wegovy…’ as reported by Mariam E Sunny in Reuters. I am surprised, though not surprised, that TDOC shares rose 11% on the news, and will be keen to see how this approach aligns with the Livongo diabetes platform that was acquired by TDOC back in 2020. Will TDOC be any different in this regard than from others in the market, such as Calibrate, Form, Found and newbie to the space, Ro Health?
- Sarah Toy, in The Wall Street Journal, reports that ‘…Bariatric surgery was performed on 506 children in 2022 at the more than 40 U.S. children’s hospitals that use a billing database called the Pediatric Health Information System, a fivefold increase from 2012.’ The numbers are supported by a quote from Dr. Thomas Inge, a pediatric bariatric surgeon in Chicago, that ‘…People with severe obesity who received bariatric surgery as teenagers were healthier in the long run than people who waited to get it as adults.’ and further driven by Dr. Sarah Hampl, a pediatrician in Kansas City, stating ‘…There’s no evidence that there’s any benefit to watchful waiting.’
- Henry Dimbleby, a well-known businessman and cookery writer in the UK, having also written the national food strategy that recommended taxes on salt and sugar, has been quoted to say that Britain cannot ‘…drug its way of out of the problem…’ of obesity, as reported by The Times of London. At one speech, ‘…Dimbleby cited a Japanese law that requires companies to measure the waists of their employers and send those above a certain size on weight-management courses.’ This is indeed taken out of context, and more likely refers to the annual medical that companies are required to provide all full-time employees over the age of 40, which does include a measurement of waist size.
OPINION
- You will recollect the recent Academy Award for Best Actor won by Brendan Fraser for his portrayal of Charlie in The Whale, of a gay man who weighs 600 pounds. This week, in Psychology Today, Kari Anderson, a licensed professional counselor, coach and consultant, writes ‘…The Whale brought up strong emotions for me.’ She continues with a passage on the addictive nature of binge eating ‘…He eats to numb his pain but also sadly to harm himself. One binge episode, brought on by rage, was truly depicted: a frenzied, dissociative process of stuffing anything edible he could find. It wasn’t about the food. He understood that he was dying, his health compromised due to too much strain on his heart, and yet, he continues. He loses hope.’ Whilst Kari notes the ‘…outrage over obesity medication and surgery recommendations…’ she goes on to rightly state that ‘…binge eating disorder is a real mental health issue…’ This is why any treatment approach for people with obesity and metabolic disease needs to be multimodal, needs to be whole-person, and needs to be individualized – medication and bariatric surgery will only be truly successful for healthier and happier patients if there is a support system, both chronic and acute when necessary, available to the patient at their convenience and in times of greatest need.
- I love the story in NPR this week, leading with a picture of 27-year old Maria Caprigno smiling from ear-to-ear whilst at Disney World, with her son Harry. Maria weighed over 440 pounds during her middle school years, and ‘…felt ruthlessly hemmed in – socially, emotionally and physically – by her increasing size, which she could not control through exercise or numerous diets.’ Alarmingly to some, or many even, Maria ‘…got bariatric surgery in 2010, at age 14, when such treatment for teenagers was largely unheard of.’ This takes me back to when we started the adolescent bariatric surgery program at the University of Pennsylvania with Children’s Hospital of Philadelphia, aligned with my adult bariatric surgery practice down the street at Hospital of the University of Pennsylvania. I recollect being told that we should not be operating on teenagers, they should be able to lose weight through diet and exercise, and they only had themselves to blame. The article references Dr. Evan Nadler at Children’s National Hospital in Washington, D.C., and Dr. Thomas Inge, at Lurie Children’s Hospital of Chicago, both staunch advocates of adolescent bariatric surgery, with numerous academic articles to support the practice and its outcomes. Dr. Inge puts it clear and straight, such that ‘…You’re going to live longer…’ and ‘…You’re going to be healthier and live longer with the surgery than without it.’ which is pretty much the case not just for adolescents, but the vast majority of adults undergoing bariatric surgery.
- Darius Tahir and Hannah Norman at KFF Health News summarize the hype and social media influencer craze on TikTok, inclusive of telehealth weight-loss companies Accomplish Health, Ro, and Sequence [recently acquired by WeightWatchers].
- As somewhat of a follow-on to the recent investiture of Ro into the GLP-1 telehealth business, the CEO Zachariah Reitano, also known as just ‘Z’, pens a substantive 70-minute read on the Ro website, to ‘…Answer some of the most common questions people might have about obesity and GLP-1s; Ground the conversation in more data and less opinion; Reduce even one person’s bias (conscious or subconscious) towards people with obesity.’ Z goes on to catch the reader off guard to state ‘…I know you might think this post is from just another startup founder in support of their own solution’… which is exactly what most people are thinking!
- The article goes into problem status, and the dooming reality that over 50% of the adult US population will be obese by the year 2030, to focus upon an effective and scalable solution such that ‘…the advent of GLP-1s represents a new frontier in the fight against obesity. We finally have a treatment that is both effective and feasibly scalable (holding cost aside for a moment).’ There is a section, ‘In layman’s terms, how do GLP-1s help people lose weight?’ related to mechanisms of action, and further, why maintenance of weight loss is so hard. He also discusses the relevance of GLP-1 drugs for the long-term, including ‘…why people regain weight after stopping the medicine.’ Rightly so, the author states ‘…The only method known to maintain weight loss after the intervention in most patients is bariatric surgery. The reason is simple. The intervention is ongoing because the anatomic changes caused by the surgery remain.’ He goes on to mention ‘…surgery is not for everyone and unfortunately inaccessible for most (~250k done per year).’
- The rest of the article goes into numerous topic areas that reflect the mass media hype on GLP-1 medications, to consider drug costs, the unknowns of long-term GLP-1 use, specifically to risks of thyroid cancer, ‘Ozempic Face’, GLP-1 drugs for kids over the age of 12 years, prevention versus cure of obesity, and higher rates of obesity among ‘…the poor and uneducated’, and finally, a brief comment on body positivity.
- Overall, the article is both a broad survey of the current state of obesity treatment as well as an attempt to drive scientific credibility toward Ro’s commercial purpose, which I admire – for real. But there is a clear focus on GLP-1 medications, with little discussion on the need for a multimodal approach, that meets patients where they are, and where they want to go – in my twenty-plus years of clinical practice, whether it be for care of patients with severe obesity, gastric reflux or esophageal cancer, my first and foremost intent was to determine the goals of treatment – for the patient themselves. Infrequently, I would even have a patient or two refuse potentially curative cancer surgery, and rather live their last few months without medical intervention; often to spend time with their family, their friends, or just simply to take the cruise to Alaska they had been planning for years. In this realm, I urge any and all practioners in this field to consider an approach whereby a whole-person, individualized, multimodal platform of care is available for people with obesity and metabolic disease. Bariatric surgery, whilst initially scary, is truly the most effective long-term therapy for people with a BMI of over 30, or over 27 with significant co-morbidities; putting this together with pre-operative [or neoadjuvant] behavioral, nutrition and exercise therapy, and post-operative [or adjuvant] medications such as GLP-1s, is akin to a lifelong therapeutic approach – just in the way we treat cancer today – as a multimodal, individualized approach to drive toward cure of the disease, and avoid recurrence and complications.
- We have a ton to learn about this approach for obesity and metabolic disease, to put the individual tools together, and to achieve the greatest effectiveness for people who have been suffering with obesity and metabolic disease…. and to do all this at reasonable cost. It is truly achievable, but the offering needs to be bring all the individual modalities together, rather than pitting one treatment approach against the other.
DATA
- Dr. Despres, a Professor at Université Laval in Quebec City, Canada, writes briefly on ‘BMI versus obesity subtypes in the era of precision medicine’ in The Lancet Diabetes & Endocrinology. The gist of the article is that ‘…there can be considerable variation in the health status of people with identical BMI values when compared…’ with the resultant determination that ‘…Age, sex, smoking, body composition, and lifestyle habits modulate the health risk associated with a given BMI.’ I could not agree more – and would add to the list in terms of race, social and economic status, as well as factors related to family, professional and community circles of engagement. These are the reasons we are more likely to become obese, so why not account and manage them upfront, rather than focus upon BMI or weight alone.
- Researchers from three major hospitals in Rome, Italy just reported in the Lancet, a highly prominent academic medical journal, results of a three-arm randomized controlled trial for patients with non-alcoholic steatohepatitis, or NASH – a precursor to end-stage liver disease, also commonly associated with obesity, and type 2 diabetes. In fact, by 2030, NASH is predicted to affect 27 million people in the USA alone. Whilst lifestyle modifications and novel GLP-1 medications may achieve 10-15% total weight loss, they have not been shown to achieve resolution of NASH. In this study, 288 patients were subjected to either lifestyle modification, gastric bypass, or sleeve gastrectomy. Total percentage of weight loss was 5.5% in the lifestyle, 31.8% gastric bypass, and 24.0% in the sleeve gastrectomy groups, with resolution of NASH in 16%, 56% and 57% of patients, respectively. Importantly, on this somewhat sicker group of patients, no deaths or life-threatening complications were reported, determining the quality and safety of the surgical procedures. The authors concluded that ‘…Bariatric-metabolic surgery is more effective than lifestyle interventions and optimized medical therapy in the treatment of NASH’ with additional improvements of insulin resistance and lipid markers.
Kind regards, Raj
