Neffy iffyness

A couple of weeks ago we told you about neffy, the nasal-spray epinephrine alternative to EpiPens that was approved by the FDA.

Apparently there was one liiiiiiitle bit of info left out — info that has prescribers a bit unsure about it. “[S]tudies have not yet been done on people who are in the throes of life-threatening allergic reactions, known as anaphylaxis.”

That makes sense — although the FDA approved neffy for anaphylactic shock, that wasn’t tested. (You can’t ethically trigger an anaphylactic reaction, even in grad students.) And it’s possible someone’s nose could be clogged, preventing the med from getting in.

And then there’s American exceptionalism: “[D]octors say they may avoid prescribing the new spray just after it hits the market, in part because they would need to devote employee hours to getting on the phone to press insurance companies to cover it.”

Still, neffy has a lot going for it. It has a longer shelf life (two years!). The cold doesn’t bother it anyway. Neither does the heat; no special storage is required. Nor is training beyond “Find your nose,” which studies have shown most people can do^*.

Got it in one

^* “[neffy maker] ARS found no harm to the eyes if the user accidentally squirts the medicine into them.”

Always a few years away

The latest universal flu vaccine candidate comes from [puts on blindfold, spins globe] the Cleveland Clinic’s Lerner Research Institute. Their tack: Go big.

First, they used a database to look at thousands of strains of the flu and (using the scientific version of Ctrl-F) found which amino acids are present in every strain of the influenza virus.

With that info, they identified eight proteins from the H1, H2, H3, H5, and H7 types — “It’s like creating a greatest hits album” — that they used to create a whopper of a vaccine. They called the process COBRA, for Computationally Optimized Broadly Reactive Antigens.

Then they tested the vax on mice, and it worked. Which means they’re looking at beginning human testing; they’re hoping to launch clinical trials within the next few years. They’re also hoping their protein-finding technique can be used for other viruses.

The Long Read: Local (non-pharma) hospital news

Two Georgia hospitals that have closed — the urban Atlanta Medical Center and the rural Southwest Georgia Regional Medical Center — might have a new lease on life thanks to bipartisan legislation that eased the certificate of need rules for building new hospitals.

What’s next for drug-price negotiations?

Speculation has already begun for which 15 drugs CMS will mark next for price negotiations. It’s required to release that list by February 2025, and the negotiated prices will take effect in 2027.

Topping the list (and keep in mind this is all speculation) is Ozempic. Remember, it’s only approved for diabetes, and it’s been on the market since at least 2017.

Other possible 2027 candidates include Pfizer’s cancer drugs Ibrance and Xtandi, GSK’s asthma and chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta, Teva’s Huntington’s disease treatment Austedo, and Abbvie’s irritable bowel syndrome drug Linzess, according to five analysts as well as researchers and company executives.

These are what taxpayers, via Medicare, spend the most on. Ozempic alone costs so much that it has a noticeable effect on the deficit: “Medicare spent over $4.6 billion on the drug in 2022.”

Short takes

Free Covid tests are back

Covid’s picking up, so HHS is renewing the ‘free tests by mail’ program. Starting next month, people will be able to order four free tests via covidtests.gov.

In case you care

“CVS Health has recently overtaken Walgreens as the most popular drugstore retailer among drugstore/pharmacy shoppers.” (But “It’s not clear whether CVS will be able to sustain this lead.”)

GLP-1s suicide connection?

What’s with semaglutide and suicidal thoughts? The current answer is “There might be a link, but there might not be.”

During trials of another GLP-1 agonist, liraglutide, researchers found a tiny increase in suicidal ideation among patients (0.3% compared with 0.1% of those taking placebo). But when semaglutide hit the mainstream, more reports came in — back in January we told you that that the FDA was looking into some reports.

The latest is … dueling studies, both based on worldwide health data, albeit from different sources. One in January did “not support higher risks of suicidal ideation with semaglutide.” But another, which came out this month, found there was a disproportional amount of suicidal thoughts among semaglutide users.

So what’s to be done? Keep an eye on patients, everyone says, especially those with depression or an anxiety disorder. And, of course, do more research.