24 Jun 2022
Posted by Andrew Kantor
The FDA has ordered Juul to pull all its e-cig products from the market.
In short, in its product application, the company provided insufficient or contradictory evidence that its vaping products were safe.
[T]here is insufficient evidence to assess the potential toxicological risks of using the JUUL products. There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device.
“Retailers should contact Juul with any questions about products in their inventory,” said the agency.
Earlier this month, a small health system in Virginia agreed to pay a $4.36 million civil settlement (and avoid criminal charges) because two employees had diverted a whole lotta drugs for a whole lotta time. It’s not the first.
But the big takeaway here, as FDA Law Blog explains, is that the employer was liable for the actions of its employees because it didn’t do enough to prevent it*.
While the two employees in this case devised separate and independent schemes to divert controlled substances, the common element was a lack of an effective corporate security program and monitoring of existing policies and procedures to prevent and detect diversion. (Emphasis ours.)
For extra fun, read the article and see the list of “extraordinary compliance terms” the health system is required to implement.
Normal flu shots aren’t good enough for older people, a CDC panel says. They need to get the better, stronger vaccine that will offer more protection for their frail, weakened immune systems.
Options include: Fluzone High-Dose, Fluad with an immune booster, or Flublok which is made with insect cells instead of chicken eggs.
Polio — remember polio? (Hopefully not.) Polio is back in Britain, where the virus was detected in London sewage. It’s the first time in 40 years the virus has appeared.
There haven’t been any cases of the disease, but British health authorities are telling people to be sure they’re up to date with their shots.
And that’s a good reason not to worry. Even if it comes to America, we’ve got a good, proven vaccine that everyone will be sure to take so the deadly, crippling disease doesn’t spread.
Meningococcal diseases have appeared (including meningitis) — at least 26 cases and seven deaths.
T-cells are our friends … unless we have heart failure. Then they get a little over-enthusiastic and cause inflammation, making that heart failure worse.
“How?” you ask. By increasing the amount of a protein called estrogen receptor alpha. “So stop it,” you say. That might not be possible, but what is possible — found researchers at an Ohio State University — is a new molecule “that activates estrogen receptor beta, which is known to have an opposite effect of estrogen receptor alpha.”
Activate the beta, they say, and heart failure stops.
“With this drug, we may be able to significantly improve the lifespan of patients, and if we stop the disease at an early stage, patients may not even need a heart transplant.”
The research was partially funded with tax dollars, but naturally OSU (also funded with tax dollars) has patented the drug.
Maybe you want to get a little side training: Apparently acupuncture can relieve headaches. Not all, but according to a paper in the journal of the American Academy of Neurology, Neurology, it does seem to relieve tension-type headaches.
The study was small (218 people), but it did compare “true” acupuncture with “superficial” acupuncture and found that…
At the end of the study, 68% of the people receiving true acupuncture reported at least a 50% reduction in the monthly number of headache days compared to 50% of the people who received superficial acupuncture.
When the The U.S. Preventive Services Task Force said, earlier this year, that healthy people don’t need to take low-dose aspirin, that confused stroke patients.
The problem is that the headlines have sounded definitive (‘Stop taking aspirin if you don’t have heart problems’) but the reality is more subtle. Most importantly, “For those who’ve had a past stroke or heart attack, that medical history doesn’t just go away, even if it’s been a number of years.”
In other words, once a stroke patient, always a stroke patient. So health experts are urging people to talk to their doctors, not just follow the headlines.
If, like most people, you’ve woken up at 3:00 am worried about mugwort allergy, there’s potential good news coming down the pike: Viennese researchers have uncovered how the major mugwort pollen allergen triggers a response.
Knowing how it works is “the basis for the development of a vaccine against mugwort allergy,” which will hopefully be in the works soon. Rest easy.
Sunscreens wear off in a few hours when the avobenzone it’s based on is broken down by the very sunlight it protects you from. Hence the reminder to reapply it often.
But now NYU materials chemists have created a new, better molecule — essentially avobenzone with a “support structure” called a dendrimer.
We found that the supported avobenzone did not decompose when exposed to UV light over time, even after 24 hours—and you’re not on the beach for 24 hours! Our tests even showed that adding the dendrimer support not only eliminated decomposition but increased avobenzone activity over time.
They’ve of course patented this molecule and are hoping to test it in a lotion soon. But will sunscreen companies rush to create a new product that consumers will use much less of?
The good news:
[T]he US is not overly dependent on one country for its broader supply of antibiotics, with Canada, India, Italy, and China supplying the bulk of demand.
The bad news:
[F]or individual antibiotics, China is the main source of the ingredients for penicillin and cephalosporin, which represent approximately two-thirds of the antibiotics used in the US each day.
And thus, across both government an industry, “US frets over pharma supply chain security.”