The well-intentioned “Time to lose weight” recommendation from doctors to their overweight patients may actually end up doing more harm than good. Of the 30% of Americans that are now considered clinically obese, physicians are facing a growing dilemma of how to treat medical problems without using their weight as a blanket explanation. Pain in your chest? Get to the gym. Agonizing back pain? Cut the calories. Research shows that this type of thinking results in physicians spending less time with overweight patients, and even forgoing recommendations for potentially life-saving diagnostics tests. It’s no surprise that this can lead to pretty awful health outcomes that could be preventable at any size. So in the words of a nondescript wise man, “Assumptions. Can we like, not?”
This week, United Health announced a proposal to drop Sanofi’s insulin Lantus and Amgen’s bone marrow stimulant Neupogen in favor of their biosimilars. AND THEN, the FDA approved Amgen’s biosimilar version of Humira. Good week for biosimilars, bad week for Lantus, and meh week for Amgen (especially since AbbVie is still suing for patent infringement). This is only the fourth biosimilar licensed by the FDA under the Biologics Price Competition and Innovation Act, but the true test will come if more payers, like United, drop the branded products completely. ICYMI: Biosimilar safety and interchangeability are still questioned by some.
What’s super-fun, kinda scary and has the potential to save the US almost $4B in healthcare costs a year? Rollercoasters, duh. An interesting discovery by Dr. David Wartinger, a urological surgeon who has dealt with kidney stones for decades, was that upon returning from summer vacations to amusement parks his patients came back with fewer kidney stones. Curious about the possibility, he designed a little study, made a model of a kidney and hit the coasters. When riding in the back of the coaster, the model kidney passed the stone ~64% of the time. Armed with some foundational evidence to prove the concept, Dr. Wartinger has planned out a prospective clinical trial to see if the results can be validated.
Influenza vaccination rate:
How severe would your condition have to be in order for you to take a medicine that has shown promise in clinical trials, but the FDA did not approve it based on a lack of scientific rigor? (By the way, these are the scales used in SAE reports – just dropping some second-level info on you)
As President of the National Association of State Boards of Education in 2012, Gayle Manchin started a campaign to place epinephrine auto-injectors into schools nationwide to treat students facing life-threatening allergic reactions. This movement led to several laws that either required or gave funding preference to schools that kept epinephrine auto-injectors in-stock. Mylan, maker of the EpiPen – one of the only epinephrine auto-injectors – then worked to outfit schools everywhere with the life-saving drug. We’re sure Mylan CEO, Heather Bresch, was on board with the idea. You’re supposed to do what your mom tells you to do, right? Oh, did we not mention that Bresch and Manchin are related? That’s probably not relevant. This is how we felt.
What acronym is worth six points in Scrabble, but is really worth much more? mRNA. (Note: it would be worth 15 points if you spelled out “messenger.”) Two recent financing transactions highlight just how much the industry is valuing this approach to drug development. Moderna, a MA-based startup with a reported valuation of $5 billion is spending $110M on a manufacturing facility while its most advanced programs are in Phase II (seems a bit optimistic). Also this week, Genentech bought into the race to realize the potential of messenger RNA-based personalized cancer vaccines by committing $310 million in upfront and near-term payments to BioNTech to partner on its mRNA cancer vaccine platform. Might want to Wikipedia mRNA sometime this week. We’re just saying.
The first drug therapy for Duchenne muscular dystrophy (DMD), eteplirsen, is now on the accelerated approval pathway by the FDA. It’s a gene therapy that allows 13% of DMD patients to partially produce an otherwise absent protein, which slows the progression of DMD. At least, that’s what the supposed clinical benefit is. Trials run by Sarepta Therapeutics, the drug’s manufacturer, do show an increase in the otherwise missing protein, but haven’t effectively linked those increased levels to a clinical benefit yet. The trials performed so far weren’t randomized, which our readers may recognize as… not the best way to collect unbiased data. But the increased protein levels seem promising enough for the FDA. The accelerated approval also comes with priority review and an orphan drug designation.