Accelerated doesn’t mean unlimited

Right now, if the FDA gives a drug accelerated approval, there’s kind of a big flaw: It’s hard to revoke that approval if negative data shows up.

Accelerated approval means the agency is pretty sure the drug works, and getting it to people is important — think pandemic. So the drug is approved with the understanding that the drug maker will soon provide detailed proof that the drug works.

And if they don’t? Nada. So drug makers often don’t bother. Why should they? They’ve got (conditional) approval, so why take a chance on running a study that shows their product doesn’t work?

And thus Frank Pallone, chair of the House Energy & Commerce Committee, is introducing a bill that would…

… set time limits around accelerated approvals, such as requiring the approvals to expire one year after post-approval studies are scheduled to be complete, and never later than five years after an accelerated approval.

Get yer legislative update!

Stay up to date with what’s happening in Atlanta — Melissa Reybold’s latest legislative update is live, with all the details on the bills we’re following. Think PBMs and Medicaid, insurance participation contracts, being allowed to carry controlleds in a compartmentalized container, and more.

A new weight loss drug?

We’ve all dealt with fat mice — sometimes it’s hard to get them to lose weight. But now it seems a drug intended for cancer — camptothecin — might help them lose weight.

Camptothecin can treat gastrointestinal tumors, but it’s got some awful side effects at useful doses*. But at smaller doses, Chinese geneticists found, it stimulates the release of growth differentiation factor 15. And GDF15 suppresses appetite and causes weight loss “without ill effects” in those mice.

As always, of course, “Further study is needed to evaluate its efficacy and safety.”

* But analogs of camptothecin work: belotecan, irinotecan, topotecan, and trastuzumab deruxtecan.

Tick spit, continued

Last month we told you how Aussie researchers found that tick saliva can reduce inflammation. But it seems they’re not the only ones researching it.

Researchers at Britain’s Durham and Newcastle universities found that a protein in tick spit — votucalis — “provided pain and itch relief” by binding to histamine molecules without getting to the brain.

The anti-itch and pain relief potential of Votucalis means we could be on the brink of discovering a viable alternative to opioid and gabapentinoid drugs.

Immunization training down under

Technicians down south — we haven’t forgotten you! GPhA’s got it’s hot hot hot immunization training session, coming to Douglas, Ga.*, live on Saturday, April 2.

Be ready for Rho, Upsilon, and the eventual Andromeda strain: Get your vaccine training, bragging rights, and a spiffy certificate with GPhA’s Immunization Delivery Training for Pharmacy Technicians. It’s a total of 5½ hours of CE, including home-study and live training.

Space is limited, so don’t wait — click here for all of the details and to register now!

* At the Grace Pointe Church, kitty-corner from Space Cow Creamery

Totally objective research

Which is better for your heart, almonds or French fries? Yes, it’s a trick question; we all know that almonds must be better for you.

‘Now waaaaaaaait a minute,” says a research team out of the University of Alabama and Indiana University. Their study finds that — wowzers! — despite what you might have heard…

There were no significant differences in [fat mass] or in glucoregulatory biomarkers after 30 days of potato consumption versus almonds.

And thus, “Results do not support a causal relationship between increased French fried potato consumption and the negative health outcomes studied.” (Those “negative health outcomes” were weight gain, adiposity, and diabetes risk.)

Pssst: If you listen very carefully you’ll hear the researchers say, “Funding provided by the Alliance for Potato Research and Education.”

The Long Read: Changing Colors edition

If you noticed that a lot of pharmaceutical brands tend toward blue, you’re right — it’s pretty common. But lately companies are expanding their palettes, and now purple isn’t quite as much a standout as it once was. (But brown? No, you won’t see a lot of brown.)