Hello Friends,
Welcome to October. It has been an extraordinarily busy period here at twenty30 health; amongst many other activities and initiatives, yours’ truly has been hitting the conference circuit of late, and have had the opportunity to attend excellent events at DHNY in New York and Health Evolution in Nashville.
I also had the pleasure to be engage in a fireside chat at the Fitler Club, Philadelphia with my past colleague and friend, Steve Klasko, MD, MBA. Steve was the President & CEO at Jefferson University & Jefferson Health; and now advisor to twenty30 health. It was an outstanding event, focused on “talking about truly reducing obesity for the first time”, to quote Steve.
This week’s newsletter has some concerning as well as interesting articles to cover, especially, certain adverse potential complications associated with GLP-1s. These include ileus or intestinal blockage; complications whilst under anesthesia; and suicidal ideation. BUT, to avoid scaremongering, patients in any type of weight management program, from intensive lifestyle therapy, to medications, to bariatric surgery, have such an altered physical, psychological and social aspect to their daily lives, that they must be managed in a multidisciplinary manner, that takes into account the complexity of their disease and its lifelong treatment, to avoid serious complications.
Kind regards, Raj
AT A GLANCE
- ‘The FDA has received more than 8,500 reports of gastrointestinal issues among people taking medications like Ozempic and Wegovy…’ with ileus or intestinal blockage mentioned in 33 cases, as per Lisa O’Mary at WebMD.
- Patients on ‘…Wegovy, Ozempic or similar drugs may suffer certain complications under anesthesia that can lead to pneumonia…’ notes Ludwig Burger of Reuters, from a report at the European Medicines Agency.
- Dawn Heidlebaugh is ‘…one of four U.S. patients who told Reuters about experiencing suicidal thoughts while taking Novo Nordisk’s popular Ozempic drug.’
- An announcement this week that the ‘…Biden-Harris Administration Announces More Than $8 Billion in New Commitments as Part of Call to Action for White House Conference on Hunger, Nutrition, and Health.’
- The CDC 2022 Adult Obesity Prevalence Maps revealed ‘…19 states had an obesity prevalence between 35% and less than 40%…’ and ‘…3 states (Louisiana, Oklahoma, and West Virginia) had an obesity prevalence of 40% or greater.’
NEWS
- ‘The FDA has received more than 8,500 reports of gastrointestinal issues among people taking medications like Ozempic and Wegovy…’ with ileus or intestinal blockage mentioned in 33 cases, as per Lisa O’Mary at WebMD. This is a known effect of GLP-1 medications, in that they slow down gastric emptying, and in extreme forms, can lead to severe constipation, or ileus.
- In an FDA approval update, it ‘…announced that the potentially life-threatening condition will be listed on the drug’s label.’
- The labels of Wegovy and Mounjaro acknowledge the same, and Ozempic’s label has been updated now too.
- Patients on ‘…Wegovy, Ozempic or similar drugs may suffer certain complications under anesthesia that can lead to pneumonia…’ notes Reuters reporter Ludwig Burger, from a report at the European Medicines Agency. The mechanism is slowed gastric emptying, which means food is in the stomach for longer, and puts the patient at risk of reflux of the stomach contents into the lungs when a patient is put under anesthesia, potentially leading to pneumonia. This is why patients are told to fast for a few hours prior to anesthesia.
- An announcement this week that the ‘…Biden-Harris Administration Announces More Than $8 Billion in New Commitments as Part of Call to Action for White House Conference on Hunger, Nutrition, and Health.’ The conference met with the goal to ‘…lay out a transformational vision for ending hunger and reducing diet-related disease by 2030.’
- The five pillars aim to Improve Food Access and Affordability, Integrate Nutrition and Health, Empower Consumers to Make and Have Access to Healthy Choices, Support Physical Activity for All, and Enhance Nutrition and Food Security Research.
- A total of 63 partners from business, civic, academic, and philanthropic backgrounds are listed, from Chobani, Doordash, Danone, Walgreens and Instacart, to Google, Novo Nordisk, Warner Bros. Discovery, with the American Academy of Pediatrics, Boston Medical Center, University Of South Carolina School Of Medicine Greenville, Special Olympics, American Heart Association, Rockefeller Foundation, and YMCA.
OPINION
- Dawn Heidlebaugh is ‘…one of four U.S. patients who told Reuters about experiencing suicidal thoughts while taking Novo Nordisk’s popular Ozempic drug.’ After taking the weekly injection on Sunday, ‘…every Tuesday, she felt lethargic, depressed and sometimes suicidal, thinking her husband and four children might be better off without her.’
- The FDA has ‘…received 265 reports of suicidal thoughts or behavior in patients taking these or similar medicines since 2010…’ of which 36 ‘…describe a death by suicide or suspected suicide.’
- Thomas J. Moore, at the Johns Hopkins Bloomberg School of Public Health, sits on both sides of the fence: it ‘…doesn’t mean to automatically blame the drug…’ but it also ‘…does mean that a patient’s complaint should not be automatically dismissed.’
- Importantly, ‘…symptoms ceased after the patient stopped taking the drug or lowered the dose.’ Indeed, this is not a new finding – almost 15 years ago ‘…Sanofi’s Acomplia, which never won U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts. The weight-loss drug Contrave carries a black-box warning about suicidal thinking, and another obesity medicine, Qsymia, carries a warning telling patients to stop taking it if they experience suicidal thoughts.’
- Missing in the reporting here is the change that occurs in psycho-social experiences after significant weight loss – I have seen it in my own patients after bariatric surgery; the vast majority are healthier and happier… though there are some that struggle with their new body image, their inability to engage in activities such as a Sunday cookout, or their newfound attractiveness from others. I am simply focused upon the necessity for supportive behavioral therapy for anyone undertaking a weight management program, be it through medication, surgery, or other domains. The pill is not a magic potion… weight management is a complex process, that demands specialist care over a multi-year period.
- Large companies often put some of their revenues aside to invest in other entities, often in the form of a venture fund. Scott Beardsley, managing partner of the Venture Investments group at Novo Holdings, manages between 7% and 8% of available capital, somewhere around $1.68 billion today, in a STAT News article from Allison DeAngelis. The ‘…group has typically invested between $500 million and $600 million in a given year…’ and whilst they ‘…are willing to look at obesity, but the bar is pretty high.’ According to executives ‘…the venture team is shying away from weight loss medication pitches.’
- Something that I had thought but not voiced to date, with the advances of GLP-1 biotechnology, is when the timing would be right for the Nobel Prize Assembly to reward researchers who have made significant contributions to the field. Megan Molteni and Elaine Chen write a long piece on the history of GLP-1 discovery, asking ‘Could a Nobel be next?’ They cover Richard Goodman’s work on anglerfish DNA, to Svetlana Mojsov in Boston, Neil McIntrye in London [who I incidentally did ward rounds with as a young medical student], surgeon Jens Juul Holst in Copenhagen, Stephen Bloom in London, through to Novo Nordisk researcher Lotte Bjerre Knudsen, and more recently to the work of Matthias Tschop and Richard DiMarchi over the past twenty years.
DATA
- The CDC 2022 Adult Obesity Prevalence Maps for 50 states, the District of Columbia, and 3 US territories revealed ‘…19 states had an obesity prevalence between 35% and less than 40%…’ and ‘…3 states (Louisiana, Oklahoma, and West Virginia) had an obesity prevalence of 40% or greater.’
- In addition, ‘…Obesity prevalence decreased as level of education increased…’ with ‘…notable differences by race and ethnicity.’ Indeed, ‘…the number [of states] with an adult obesity prevalence of 35% or higher, by race/ethnicity…’ was 38 for non-Hispanic Blacks, 32 for Hispanic adults, 14 for Non-Hispanic White adults, and zero for Non-Hispanic Asian adults.
- The charts and slides on the CDC webpage are well worth a look – and tell a very sad story not only of obesity and its increased prevalence over the past decade in our country, but even more so of the racial, social, and economic inequities that exist and continue to expand in America today, conveniently noted as social determinants of health – or as Dr. Sachin Jain puts it – poverty.
- Pitchbook, the self-professed leading resource for comprehensive data, research and insights spanning the global capital markets, published a healthcare future report on weight loss drugs.
- The downloadable report seeks to ‘…sketch out potential short- and long-term implications of the rise of weight loss drugs on the VC and PE healthcare ecosystems — spanning biopharma, digital health, healthcare services, medtech, and healthcare IT.’
- The authors ‘…believe that compelling clinical results and popular pressure will result in broad coverage of these drugs for patients with obesity…’ though ‘…payers may impose prior authorization requirements to limit coverage to patients who have a BMI above a certain threshold or who have comorbidities.’
- On the pharma side, expansion of drug indications, improved efficacy and drug delivery, trial recruitment challenges, and long-term effects of GLP-1s are mentioned.
- In respect to digital health, there is ‘…a significant opportunity for telehealth companies to focus on weight loss as a primary business model…’ with a lack of differentiation too. There is ‘…potential for an entirely new ecosystem of digital health startups to take advantage of a growing population of weight loss patients by offering services including telehealth, medication adherence, and prescription management…’ to be built from the ground up, which is exciting for sure.
Kind regards, Raj
