AT A GLANCE
- Endpoints News leads with the surprising twist, that the FDA said it would rethink ending the shortage of Eli Lilly’s weight loss drug tirzepatide.
- The UK National Health Service receives a £279 million boost to tackle significant health challenges, from Eli Lilly.
- Greg Justice at asteriskmag asks How Long Till We’re All on Ozempic?
- An unprecedented online cash grab powering telehealth’s GLP-1 ‘gold rush’ is reviewed by Katie Palmer in STAT’s special report.
- Robert Califf, renown cardiologist and FDA chief, says in a STAT interview that ‘…the data on bariatric surgery, which can now be done with very low risk, look really good for long-term outcomes.’
- Despite higher upfront costs, bariatric surgeries offer two more quality years of life compared to GLP-1 therapies, reported by Becker’s Hospital Review.
- The Financial Times on India’s copycat drugmakers gear up to offer cheaper weight-loss drugs.
NEWS
- Endpoints News leads with the surprising twist, that the FDA said it would rethink ending the shortage of Eli Lilly’s weight loss drug tirzepatide after it was sued over the move.
- Essentially, certain pharmacies can keep making their own copycat versions of the drug without worrying about the agency taking enforcement action.
- So why did the FDA decide to pull the drug from its shortage list — and what prompted it to reverse course so quickly?
- Tenille Davis, chief advocacy officer at the Alliance for Pharmacy Compounding, said ‘…This is all uncharted territory.’
- Additionally, the FDA’s waffling on tirzepatide could bode well for semaglutide compounders and patients, such that the agency might take a more cautious approach when determining whether to declare an end to the shortage of Novo Nordisk’s weight loss drug.
- The UK National Health Service receives a £279 million boost to tackle significant health challenges, from Eli Lilly, for a five-year trial in Greater Manchester of the weight loss drug Mounjaro.
- The intent is to look at whether using the drug will reduce worklessness and NHS use.
- Around 250,000 people are expected to receive the Mounjaro jab over the next three years, with up to 3,000 people eventually taking part in the study.
- This will enable researchers and policymakers to explore benefits to the economy too, reducing the number of sick days caused by obesity.
- Amanda Pritchard, chief executive of the NHS, said ‘…We know weight-loss drugs will be a game changer, alongside earlier prevention strategies, in supporting many more people to lose weight and reduce their risk of killer conditions like diabetes, heart attack and stroke.’
- Great job NHS – this is innovative and will be a worthwhile endeavor for not just the UK, but managing obesity across the globe.
OPINION
- Greg Justice at asteriskmag asks How Long Till We’re All on Ozempic?
- He notes over 100 million Americans, and possibly many more, could benefit from GLP-1 drugs, with the query on when can they expect to get them?
- Quite remarkably, Gallup estimated that 15.5 million Americans have tried them, and half as many are currently using them.
- Utilizing a data-based approach, with multiple key assumptions, and running a Monte Carlo model 10,000 times, there is a patient-year supply of around 18 million by 2030; which can be bolstered to 24 million with planned supply increases from manufacturing expansion.
- Taking into account additional characteristics of insurance, patient adherence and pipeline drugs for obesity, Justice predicts that the supply of GLP-1s will increase from eight million patient-years to roughly enough for approximately 23 million Americans by 2030.
- Regardless, this is only enough supply for about 15% of the 147 million Americans with diabetes or obesity.
- JAMA Internal Medicine on the Path to Sustainable Obesity Care… from the selection of optimal patients for GLP-1 treatment, to their long-term effects, to how to manage their costs.
- The science behind obesity care begins with the acknowledgment that obesity is a chronic disease, necessitating some form of lifelong intervention.
- There is interest in off-ramping strategies of prescribing lower or less frequent doses of a GLP-1RA, continuing older, cheaper, well-tolerated weight loss medications; and offering lifestyle support programs with a focus on structured physical activity or diet.
- Importantly, evidence to define the appropriate duration of therapy and optimal strategy for tapering, discontinuing, or off-ramping GLP-1RAs where able will be a critical next step on this path to sustainable, global access to obesity care.
- An unprecedented online cash grab powering telehealth’s GLP-1 ‘gold rush’ is reviewed by Katie Palmer in STAT’s special report.
- The report found that just a handful of networks of doctors, nurse practitioners, and physician assistants are writing prescriptions for dozens of websites offering the weight loss drugs, including compounded versions.
- Obesity physician Scott Kahan refers to it as ‘…a humongous red flag, and very scary to me.’
- While many telehealth sites do not disclose the medical groups they work with, of the 81 in STAT’s analysis that did, nearly two-thirds were affiliated with just four medical networks: Beluga Health, MD Integrations, OpenLoop Health, and Colchis Medical Group.
- Beluga Health was listed as the medical group for at least 28 telehealth companies.
- It can be a lucrative career choice noted Trace Owens, a nurse practitioner who said he makes as much working telehealth 20 hours a week as he did working six days a week at an urgent care.
- Joey Mattingly, a pharmacy professor at the University of Utah notes prescribing compounded GLP-1s is ‘…not about care… It’s opportunism. It’s a money grab.’
- Clinicians who prescribe GLP-1s online maintain that their medical decisions are independent, uninfluenced by the financial interests of telehealth companies, and that clinical protocols are in place to deliver appropriate care.
- Robert Califf, renown cardiologist and FDA chief, says in a STAT interview that ‘…the data on bariatric surgery, which can now be done with very low risk, look really good for long-term outcomes.’
- But sadly he adds that access seems to be more dependent on who you happen to see as a clinician than what might be an evidence-based practice.
- I know this well having worked at the leadership level to health systems across the US, UK and Canada too.
DATA
- JAMA Pediatrics on almost 7,000 adolescents with obesity, with those who initiated treatment with a GLP1 drug having a 33% lower risk of suicidal ideation or attempts at up to 3 years of follow-up.
- The study utilized electronic health records data of adolescents aged 12 to 18 years, from the TriNetX global federated network, between December 2019 and June 2024, across 120 health care organizations, mainly in the USA.
- The prescription of GLP1 meds was associated with a 1.45% risk for suicidal ideation or attempts over 12 months of follow-up, compared to 2.26% in the control group.
- Despite higher upfront costs, bariatric surgeries offer two more quality years of life compared to GLP-1 therapies, reported by Becker’s Hospital Review from Northwestern Medicine researchers.
- From an intervention cost of $11,628 annually for GLP-1 meds, and $18,581 once for bariatric surgery, the authors reviewed data on three intervention arms, i.e. bariatric surgery alone, GLP-1s alone, and bariatric surgery + GLP-1 combination.
- Whilst the authors conclude that GLP-1s are not cost-effective when compared to bariatric surgeries in the treatment of obesity; they do add that combination of both bariatric surgery and usage of GLP-1RAs offers the most cost-effective option when compared to individual interventions alone.
- Imagine that… multimodal whole-person care is the best… don’t we do that for patients with cancer and many chronic diseases?
- Duh – I love high quality research that supports common sense!
ADDITIONAL TOPICS
- The Financial Times on India’s copycat drugmakers gear up to offer cheaper weight-loss drugs.
- UK Health Minister Wes Streeting says in The Telegraph that widening waistbands are a burden on Britain, and the long-term benefits of weight-loss drugs could be monumental in our approach to tackling obesity.
- Proceedings of the National Academy of Sciences publishes data on Estimating the lives that could be saved by expanded access to weight-loss drugs.
