If you live in the US, it’s seriali“z”ation. Regardless of how you spell it, track-and-trace is coming. The Drug Supply Chain Security Act train, while delayed a bit, is still thundering down the track (pun intended). You know who hates serialisation? Smaller CMOs. Implementing serialization is expensive and without a massive number of customers over which to spread the cost, some smaller CMOs could be in a world of hurt. According to Tracelink, as many as 400 CMOs will not be ready for upcoming US and EU track-and-trace regulations. And if you can’t afford to be compliant, then perhaps the next step is to consolidate. Looks like this trend is far from over. So, buckle-up sippy cup, get your CMO strategy in line, and enjoy the roller coaster ride.
If you’re one of the estimated 60 million Americans who fill out a NCAA basketball bracket each year, then this story will resonate with you. But, you’re about to feel much worse about your health system. The New York Times decided to play bracketology with the health systems from Canada, Britain, Singapore, Germany, Switzerland, France, Australia and the U.S. by having five experts pick which system was better in head-to-head match-ups, with the winner advancing. In the end, Switzerland won, with Germany as a close second. France defeated the US in round two by a 3-2 vote. This writer is quick to acknowledge there are many different lenses through which a system can be evaluated. InsightCity readers, what do you say? Bring on the comments.
On May 20, 1506 Christopher Columbus died of what is now believed to be congestive heart failure—though at the time his diagnosis was gout, like my father-in-law who eats a steak about every 45 minutes. This is relevant, of course, because the US celebrates Columbus Day this week, in honor of the man who really would have been better off using Google Maps. Among the causes of CHF are high blood pressure, almost certainly a result of dealing with the nasty and stingy Queen Isabella and King Ferdinand. Of course, that’s just an InsightCity diagnosis from 511 years away. Here’s what’s on the horizon for patients suffering from heart failure.
If there were an activity that elevated your risk of sudden death by a factor of more than 1,000, would you partake in that activity? What if this activity were supposed to be good for you? I’m confused. According to a study published in the Annals of Internal Medicine, participating in triathlon events translates into a death rate of 1.74 per 100,000 triathlon competitors, per event. Still pretty small, but that’s 1,000 times higher than the rate of sudden death in otherwise healthy athletes. So, next time you see one of those (in air quotes) overachiever types running with their fanny pack and $300 shoes, you can rest easy knowing that maybe you’re safer driving to Dunkin’ Donuts.
While some drug brands are turning to celebrity endorsers to give their advertising efforts a boost, Merck has gone the other way in an advertisement for their new immuno-oncology drug, Keytruda. Meet Donna, a patient in Merck’s Keynote-024 drug trial that ultimately led to the drug’s approval. Why might celebs be more appropriate for some conditions than others? Maybe the extraordinarily personal and serious nature of a late-stage cancer diagnosis lends itself to not faking it? It’s probably smarter—and more effective—to have a real patient talking about her actual experiences with advanced non-small cell lung cancer and her treatment than, say, Tiger Woods, who once tried to convince us he drove a super ugly Buick.
Sometimes you conduct a study, and the results suck, but you still have to report them. That’s what the authors of an influenza safety study found last week, when they discovered an association between miscarriage and flu vaccination. It’s bad enough that this gives more ammo to antivaxxers, but it also sucks because flu vaccines are particularly important for expecting mothers. Flu symptoms can be more severe for this population, and can lead to pre-term births and miscarriages all on their own. Plus, the vaccine is the only way for developing babies to receive long-term flu protection since infants younger than six months can’t receive it. So please, protect yourself, your kids, and the rest of us too.
Getting rid of artificial sweeteners and dyes in foods, especially those targeted at children, sounds great. General Mills, the makers of Lucky Charms breakfast cereal announced in July 2015 that it was “removing artificial flavors and colors from all of its cereals.” Sweet. As the aging Lee Corso would say “Not so fast my friend.” Two years later there are still artificial sweeteners and dyes in Lucky Charms. Why? Because General Mills says, “that effort has since stalled — company scientists have yet to find natural substitutes that won’t affect flavor.” No s&*t Sherlock. It’s the same reason fat-free cheese doesn’t taste like cheese…because it’s not cheese! Many people are becoming more health conscious. Great. Our advice? Leave the bad stuff bad and make new/different good stuff.