As you know, the FDA is not too happy with JUUL for improper marketing practices aimed at America’s youth. Essentially, the agency alleges that by making vaping “cool,” they’re trying to get the next generation addicted to nicotine. Well the marketing geniuses at JUUL must have mistaken their foot for their vapes, because one of their “solutions” involved offering schools up to $20,000 to use an anti-vaping curriculum they developed. Hey y’all? That’s not a good look. After all, the tobacco industry tried to do the same in the eighties, and those education programs may have caused more students to smoke. JUUL’s version of the course would’ve included the science behind e-cigs, blaming teen use on peer pressure and, uh, mindfulness through telekinesis?? Yeah, why vape when you can move clouds with your mind (audio required)?
Put on some Snoop Dogg (do we even have to say NSFW) and your favorite Bob Marley shirt, Canada is now the world’s largest legal marijuana market. Canada is the second country in the world behind Uruguay to legalize recreational use of cannabis, but unlike Uruguay, it won’t have to deal with the financial restrictions of using US dollars to sell the stuff. The safe regulatory environment means Canada will likely turn into the world’s center for agricultural research into the plant, on everything from increasing the potency of its compounds, to the genetic sequencing of its different varieties like “CBD God Bud” and “Cold Creek Kush.” If you want to get in on the reefer madness and make the trip up to the Great White North for some weed tourism, just make sure you do your own research beforehand.
While any DTC drug commercial will likely include shots of people happily hiking and a list of side effects longer than the symptoms of the disease it’s curing, one thing you won’t see advertised is the price of the prescription. New federal policy could change that for drugs covered under Medicare and Medicaid, forcing companies to disclose list prices in TV advertisements. While most patients don’t typically pay the full price for their prescriptions, Health and Human Services Secretary Alex Azar says, “They deserve to know if the drug company has pushed their prices to abusive levels.” PhRMA says their members would be willing to include a link to a website that has pricing information in advertisements, to which Azar pretty much replied, that’s not what I meant.
The FDA is getting serious about e-cigarette enforcement. In a statement released last week, the agency announced a crackdown on 1,300+ retailers and five manufacturers who make up 97% of the US market. That includes JUUL, which has been widely criticized for making vaping cool (Editor note: LOL is this really that cool?) and itself accounts for over half the US market. The FDA says vape use has increased to epidemic levels in teens, and it is intent to not “allow a whole new generation to become addicted to nicotine.” The agency expects the manufacturers to submit plans within 60 days to explain how they’ll stop teens from getting addicted to their products. If not, the agency could pull e-cigs from the market, a move which Big Tobacco is a fan of.
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.
Chinese parents are understandably angry after the emergence of a third vaccine safety scandal in about as many years. Regulators announced last Friday that Changsheng Bio-tech (which ironically means “long life” in Chinese) had sold over 250k low-quality DPT vaccines to a Chinese public health agency responsible for 100M citizens. Hey, at least that’s better than the over 400k subpar DPT vaccines produced by a different Chinese manufacturer which authorities uncovered last November. Or the spoiled vaccines illegally sold in 24 provinces in 2016. Authorities are also sick of the scandals, so on Wednesday they announced an audit of China’s entire vaccine production system. Until that’s done, you might not see consumers springing for vaccines Made in China for a bit.
Drug shortages are nothing new, that’s why the FDA updates their list of shortages daily. But things seem a little worse than normal—9 in 10 physicians say their emergency departments lack critical medicines. That includes mainstays like diltiazem (a go-to treatment for hypertension) and morphine. You can blame market forces and manufacturing issues. Most of the drugs in shortage are sterile injectables, which can be difficult to both make and make a profit on. Those low margins can lead to less incentive to maintain the quality of sterile injectable manufacturing facilities as they age, which in turn leads to issues with the quality of the drug products. It’s things like that which can cause cardboard to contaminate batches of “sterile” injectables. If only they had contaminated them with cash instead…