Maybe when we write about the top stories of 2019, we might be calling it “The Year of the Biosimilar” – or not. In a recent press release by FDA Commissioner Scott Gottlieb, he states; “We’ve set out in recent months to advance new policies that are aimed at promoting more competition when it comes to biosimilar products. In 2019, we plan to take some additional new steps to promote these goals. We’re now going to be focusing equal attention to potentially anti-competitive practices when it comes to biosimilar drugs.” Sounds like there’s a new sheriff in town. One of the first targets might be the insulin producers. According to Dr. Gottlieb, “There are currently no approved insulin products that can be substituted at the pharmacy level.” Let’s see if Dr. Gottlieb will have the same success as Sheriff Rick Grimes. Good luck Dr. G and shoot straight.
We’re used to vulnerabilities in data systems leading to massive personal data breaches (cool visualization of those here.) But there’s an even darker side to hacking that can put peoples’ lives directly at risk. We’re talking medical device hacks. Two “white-hat” (good) hackers identified vulnerabilities in pacemakers and insulin pumps which “black-hat” (bad) hackers could use to injure patients. One scenario put forth is a pacemaker being manipulated to deliver too many or too few electric shocks, which obviously could lead to negative patient outcomes. The researchers shared their findings with the device manufacturer and relevant regulatory bodies, but they say these authorities are playing down the risks. They apparently considered bringing in a pig they could kill with an app to make their point, so we should probably take them seriously.
In a more positive biohacking story, a group of diabetics and hackers are using vulnerabilities in their medical devices to make their lives easier. Diabetes is notoriously annoying to monitor, sometimes making patients or their caregivers wake up at night to check glucose levels and dose insulin accordingly. To avoid that, patients are willing to cobble together their own artificial pancreases using hacked insulin pumps, glucose monitors, a small Bluetooth-connected computer with open-source code, and a smartphone app. The system works in concert to automatically deliver a calculated dose of insulin from the pump to moderate glucose levels. To be very clear, this is not regulated in the slightest. But it’s cheap. And it shows that if these the market isn’t addressing these patients’ needs, they’re happy to circumvent it.
Time to break down diabetes into more subtypes than the amount of Wilford Brimley parodies there are on YouTube. Ok that might be an exaggeration because there are a TON, but Swedish & Finnish researchers are making an argument that we should probably have more than just the current two subtypes. They propose keeping Type 1 as its own thing, but expanding Type 2 into four clusters that are more descriptive of their causes. The basic breakdown is: Cluster 1, severe autoimmune (the former Type 1;) Cluster 2, severe insulin-deficiency; Cluster 3, severe insulin-resistant; Cluster 4, mild obesity-related; and Cluster 5, mild age-related. According to researcher Leif Groop, this is “a real step towards precision medicine. In the ideal scenario, this is applied at diagnosis and we target treatment better.” Increasingly patient-centric approaches will always get a thumbs-up from us.
There is new research on a method to combat diabetes and obesity, and you won’t need a pharmacy card or a gym membership to give it a try—just permission to mess with the bottom line of the utility bill. A new study, “Healthy Excursions Outside the Thermal Comfort Zone,” shows that dropping your building’s temperature below the comfort zone (21-22 °C; 69.8-71.6 °F for you Americans) can increase metabolism and energy expenditure. Mild cold, specifically, can increase glucose metabolism and was shown to increase insulin sensitivity by 40% in patients with Type 2 diabetes over a 10-day period. “This is comparable with the best available pharmaceutical or physical activity therapies,” according to the study. So…go adjust your coworker’s thermostat. They can thank you later.
A secret team at Apple, made up of around 30 tech and biomedical experts, is working on a program that would use the Apple Watch as a sensor “that can noninvasively and continuously monitor blood sugar levels to better treat diabetes,” according to three bean-spillers close to the project. This was envisioned by Apple co-founder Steve Jobs prior to his death. The project has been ongoing for at least five years, and is reportedly run now by Apple’s SVP of hardware technologies, Johny Srouji. How would something like this work? Good question. According to a CNBC article, the program would “[shine] a light through the skin to measure indications of glucose.” It’s like something Q would create – for a diabetic 007.
Remember a couple of years ago when Sanofi partnered with MannKind because they believed Afrezza, MannKind’s inhaled insulin product, would capture diabetes patients who hate injections? And remember when Sanofi paid MannKind $150m up front and loaned them an additional $175m? Well, the sales didn’t materialize and Sanofi would like to pretend it never happened. So much so, in fact, they’re willing to forgive the balance of the loan—over $70m! I wonder if Sanofi needs a good news/blog writer? Then Sanofi could break up with the writer and then pay off the writer’s mortgage or something. Shares for MannKind were trading up at the time of this article. But then again, so would mine. Just sayin’.