Why is there no staph vaccine?

There’s no vaccine for staph infections, but there have been a lot of attempts at one — all failures, even when they worked in animals. What’s the deal? And with MRSA on the rise, could there be a breakthrough?

UC San Diego researchers think they know the answer to the first question. The deal, it seems, is that humans get a lot of exposure to Staphylococcus aureus. Our immune systems learn to fight it off, but at the same time the S. aureus has evolved protection.

When a bad variant comes along, it picks up that resistance. Vaccines get our immune systems going, but that immune system isn’t effective. And even “Subsequent boosters primarily amplified the ineffective antibody response.”

The good news is that now we know why these vaccines don’t work, opening avenues to break through the defenses. “If we are proven correct, an effective staph vaccine may not be too far away.”

Do you care? Of course you do

Medication therapy management — it’s one of the best ways you can care for your patients (and it’s a potential revenue stream, too).

A big step to providing MTM, though, is making sure you’re giving— and getting — the most you can. Patients will appreciate that, not to mention the lovely certificate on your wall.

Learn how to provide the best MTM you can when GPhA presents, “APhA’s Delivering Medication Therapy Management Services: A Certificate Training Program for Pharmacists.” There are even two dates available!

Sunday, September 18, 2022
Live via Zoom 8:00 a.m. – 5:00 p.m.

Click here to get the details, see the instructor, and register!

Channeling the Keystone Kops

Watching the FDA try to regulate nicotine products is kinda like watching Wil-E-Coyote chase the Road Runner.

FDA: Juul has to come off the market. It’s getting kids addicted to nicotine, and the company didn’t provide enough evidence its safe.

Federal appeals court: Hol’ up. We need more time to decide if this is okay.

FDA: Y’know what, we’re gonna pause that ban after all. “There are scientific issues unique to the Juul application that warrant additional review.”

Juul: Yay!

FDA: But we’re still gonna regulate premium cigars like cigarettes — they need pre-market review and have to carry the same health warnings.

US district court judge: Yeah, about that. No. Premium cigars are, like, super special, so you’re being “arbitrary and capricious” by requiring health warnings and not giving them an easier review process.
Also, Congress only officially said you can regulate “all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.” Cigars are special (and premium cigars are super special), so you need a stronger case to regulate them.

FDA: But…

US district court judge: I have spoken.

Ready for your link in the chain?

So the FDA has issued two guidance documents its upcoming implementation of the Drug Supply Chain Security Act (DSCSA). The good folks at NCPA have the details, but here’s the gist.

The first guidance doc (link) is all about the standards pharmacies will need to follow to be authorized trading partners, including “enhanced drug distribution security requirements, electronic only methods, and product tracing and verification of product at the package level.”

The second guidance doc (link) covers the “5 percent rule” regarding providing office-use drugs to licensed practitioners. Even if you keep your office-use deliveries below 5 percent, “such a licensed retail pharmacy may still be considered a wholesale distributor based on other activities.” You’ll want to check it out for the details.

Comments about both are due to FDA by September 6, 2022 via regulations.gov.

Taking the iron fist to prostate cancer

An Augusta University molecular biologist has a plan to attack prostate cancer: Take down its defenses, then clobber it with iron.

Iron + free radicals destroy lipids, depriving cells of energy and killing them — it’s called ferroptosis. The Augusta team’s plan is to do some gene manipulation to make prostate cancer tumors more susceptible to stress, thus more vulnerable to the iron. (The body has a “natural mechanism to cope with this unhealthy pairing of iron and [free radicals] so that a lot of good cells don’t die as a result.”)

Captain Obvious is in it for the long haul

Wait’ll they learn how much insulin diabetics are taking: “Opioid prescriptions significantly higher for patients with lifelong disabilities, study finds”.

Double Duty™

Cancer drug vs Covid

Covid treatments are still somewhat limited, so the hunt goes on for what might work. New on that list: sabizabulin, the cancer drug, which reduced the risk of death by Covid by 55 percent. Caveat: The study was small and it was done by the drug maker. Said one expert, “Overall, I think this is very exciting, although I would welcome larger and independent confirmatory studies.”

ADHD drugs vs dementia

Some mental-health drugs — specifically noradrenergics — seem to improve the effects of Alzheimer’s disease. Norepinephrine-using neurons are part of the very kinds of process disrupted by Alzheimer’s: “including attention, learning, memory, readiness for action, and suppression of inappropriate behaviours.”

This is a preliminary, “Hey, this might work” study, so more research on specific subgroups will be needed.

Too much of a good thing

We keep learning how important vitamin D is: fighting “all-cause mortality,” protecting us from the worst of Covid, even affecting mood. But keep in mind that there is a limit, as one gentleman in Britain discovered when listening to the wrong nutritionist.

The man was taking high doses of more than 20 over the counter supplements, which included 50,000 micrograms of vitamin D; the recommended daily dosage is 600 micrograms. His regimen also included higher than recommended doses of vitamin B6, Omega 3 and vitamin B9.

A month after starting, he began getting sick, but continued to take the supplements.

Doctors said the man’s symptoms — vomiting, nausea, abdominal pain, leg cramps, ringing in the ear and diarrhea — lasted three months.

He was in hospital for eight days, “during which time he was given intravenous fluids to flush out his system and treated with bisphosphonates.”