AT A GLANCE
- Novo Nordisk wants to prevent compounding pharmacies from making its GLP-1 meds, as they are too complex for manufacturers to make safely, per CNBC.
- Elaine Chen, Lizzy Lawrence and Ed Silverman at STAT on the FDA’s current flat-spin, on its about-face on shortages of Eli Lilly drug tirzetapide.
- My favorite weekly news read, The Economist, leads with ‘The everything drugs’ in the Ozempic edition.
- Addiction journal publishes patients with GIP/GLP-1 prescriptions demonstrated 40% lower rates of opioid overdose, and 50% lower alcohol intoxication.
- Novo Nordisk on the SOUL cardiovascular outcomes trial with a reduction in MACE of 14% for people treated with oral semaglutide compared to placebo.
- Nora Volkow, from the National Institute of Drug Abuse, writes in Alzheimer’s & Dementia that semaglutide was associated with 40-70% reduced risk for first-time AD diagnosis over three years.
NEWS
- Reuters reports Eli Lilly said it sued three medical spas and online vendors for selling products claiming to contain tirzepatide.
- The new lawsuits name Pivotal Peptides, MangoRx and Genesis Lifestyle Medicine of Nevada.
- Lilly has accused Pivotal Peptides of selling products claiming to contain tirzepatide directly to patients without any prescription from a medical professional, despite advertising the drugs for research purposes.
- Pivotal Peptides says it offers research grade tirzepatide.
- Novo Nordisk asked the FDA to prevent compounding pharmacies from making unapproved and often cheaper versions of its popular weight loss injection Wegovy and diabetes treatment Ozempic, arguing that the medications are too complex for those manufacturers to make safely, per CNBC.
- Indeed, Novo Nordisk has filed 50 lawsuits against several clinics, compounding pharmacies and other manufacturers over the last year.
- The drugmaker cited several risks with compounded versions of semaglutide, including unknown impurities, incorrect dosage strengths and instances where a compounded product contained no semaglutide at all.
- Elaine Chen, Lizzy Lawrence and Ed Silverman at STAT on the FDA’s current flat-spin, on its about-face on shortages of Eli Lilly drug tirzetapide.
- This marked the first time experts recall the FDA changing course about a shortage decision, in a highly unusual situation, to create an unprecedented state of disarray.
- The challenge is not just on the supply side of the pharma company, but in addition to the demand increases, that are in a state of hyper-growth.
- And importantly, the impact on compounding pharmacies and companies selling the bootleg meds, is framed by Eli Lilly having every incentive to stop compounding pharmacies from making copies.
OPINION
- My favorite weekly news read, The Economist, leads with ‘The everything drugs’ in the Ozempic edition, on how ‘…Drugs like Ozempic will change the world… with a promise to improve billions of lives.’
- The article suggests ‘…GLP-1 receptor agonists have all the makings of one of the most successful classes of drugs in history… with profound consequences for industry, the economy and society.’
- The action is now moving beyond America.
- With over two-fifths of the world overweight or obese, demand for GLP-1 drugs is voracious.
- And mostly unknown is that ‘…Semaglutide is to come off patent in Brazil, China and India in 2026.’
- Indeed, for patients, the new uses of GLP-1 drugs would mean not just longer, healthier and more productive lives, but happier ones, too.
- And rightly so, obesity and addiction may less often be seen as moral failings, but as illnesses that can be treated.
- The GLP-1 revolution is just beginning.
- Its promise is tantalizing.
- The Economist newspaper continues with The Swiss Army knife of jabs: GLP-1s like Ozempic are among the most important drug breakthroughs ever.
- Bluntly put, in the history of medicine, a few drugs tower above all others.
- Humira for rheumatoid arthritis; Prozac for depression; statins to prevent heart disease and strokes.
- All have helped patients far beyond doctors’ initial expectations and continue to benefit millions of people every day.
- A new class of drugs is set to join their ranks and has the potential to eclipse them all – GLP-1 receptor agonists.
- We can more effectively treat diabetes, sleep apnea, cardiovascular disease, polycystic ovarian syndrome and infertility, opioid and alcohol use disorder, and even prevent many common cancers – but guess what… we have known this data for almost three decades on the outcomes of bariatric surgery which also modifies the body’s natural GLP-1 levels.
- The third article from The Economist asks ‘…Will skinny still be desirable when it is more easily achieved by the masses?’
- People clamor to get on weight-loss drugs for aesthetic reasons, as well as owing to health concerns, which is not mere vanity.
- In Europe and America, it is sobering to note women with obese BMIs earn around 10% less than their peers.
- But Ozempic is not going to fix society and rid it of status games.
- Signaling that you are unique or better than others is hard-wired into human nature.
- Reminds me of the quote from Wallis Simpson, Duchess of Windsor who said ‘…You can never be too rich or too thin…’ and more recently fueled by Kate Moss in 2009 with ‘…Nothing tastes as good as skinny feels…’, sadly powering size zero models and the pro-anorexia movement; Moss retracted the quote in 2018.
DATA
- Published in the journal Addiction, electronic health record data from 136 US health systems, covering over 100 million patients, revealed 503 747 patients with a history of OUD and 817 309 patients with a history of AUD, aged 18 years or older.
- Patients with GIP/GLP-1 prescriptions demonstrated 40% lower rates of opioid overdose, and 50% lower alcohol intoxication, compared to those without such prescriptions.
- While this research cannot prove that Ozempic and similar drugs can treat addiction, more rigorous clinical trails could be a breakthrough for how we see addiction and how we treat it.
- Novo Nordisk announced results from the SOUL cardiovascular outcomes trial on almost 10,000 people with type 2 diabetes and established cardiovascular disease, and/or chronic kidney disease.
- There was a statistically significant and superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo; with a safe and well-tolerated side effect profile, in line with previous oral semaglutide trials.
- Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus, the brand name for oral semaglutide, in both the US and EU next year, with detailed results from SOUL to be presented at a scientific conference in 2025.
- Nora Volkow, from the National Institute of Drug Abuse, co-authors a paper in Alzheimer’s & Dementiato assess the potential of semaglutide in preventing Alzheimer’s Disease, or AD.
- From over one million individuals with type 2 diabetes, semaglutide was associated with 40-70% reduced risk for first-time AD diagnosis over three years, compared with patients on insulin or other GLP-1 meds.
- Preclinical studies suggest GLP-1s protect against neurodegeneration and neuroinflammation.
- This is speculative retrospective data, and as such, drives the need for clinical trials to assess semaglutide’s potential in delaying or preventing AD, from the lens of an estimated 6.9 million Americans aged 65 and older living with Alzheimer’s disease in 2024, projected to increase to 13.8 million by 2060.
ADDITIONAL TOPICS
- STAT on More state Medicaid programs consider covering GLP-1 drugs.
- Obesity Action Coalition Launches New Stop Weight Bias Gallery at HLTH.
- Christina Farr at Second Opinion asks Randi Seigel, Partner at Manatt Health, 4 questions about the future of compounding pharmacies.
- Endpoints News states Facing lost rebates, MGM Resorts to stop covering GLP-1 weight loss shots.
- Reuters reports Lilly to launch its obesity drug in Denmark.
- The 2024 International Weight Bias Summit on Ending Weight Stigma: Priorities for Action at Concordia University.
