The influencers’ Ozempic alternative

When a story begins with “The latest health trend on TikTok….” you know to get out a big grain of salt.

In this case it’s berberine, an over-the-counter isoquinoline alkaloid related to morphine. And — if you believe the “influencers”*it’s a great substitute for Ozempic.

In fact, some small and questionable studies have shown that yeah, for extremely overweight women berberine was “associated with modest reductions in body mass index, waist circumference, and body weight (around 6½ lbs).” But there’s no information about side effects, long-term use, drug interactions, or how it will work for people who aren’t obese.

And, because the people taking it are likely to be influenced by TikTok, there’s zero reason to believe they’ll take safe or reasonable doses.

* Don’t.

Did you vote yet?

GPhA members — don’t forget that you have only until Thursday, June 15 at 11:59:59 pm to cast your vote for members of the 2023–24 board of directors.

You should have received your electronic ballot from AssociationVoting to the email address GPhA has on file for you. Can’t find your ballot or have a question? Reach out to Lia Andros, GPhA’s governance manager, at (404) 419-8173 or landros@gpha.org.

FDA relaxes import rules

To help ease the shortage of cancer drugs, the FDA will be allowing imports from foreign manufacturers that aren’t approved to distribute to the US.

It’s one of the few things the government can do to ease the shortages of cisplatin and carboplatin. The drugs are privately made, and one of the major manufacturers has temporarily shut down with no clear start-up date. Still, despite the fact that the FDA doesn’t have a big red “Ease Drug Shortage” button to press, and that medication doesn’t just magically appear, people are demanding that Someone Do Something, sometimes with amusing analogies:

Philip Schwieterman, director of oncology and infusion services at the University of Kentucky health system, said, “If I go in the grocery store and I want a kiwi, there are usually kiwis there. It boggles my mind that if I want some cisplatin, I can’t get cisplatin even though it saves lives.”

What could be done, though, is to create a national stockpile of medications — but first we need to get through the current shortage.

Sorry, there is no Medication Fairy

Anti-steering law is back (and not everyone is happy)

With the end of the pandemic’s public health emergency, a law that had been set aside is back in play. It says that prescribers can’t steer Medicare and Medicaid patients ‘to facilities and services in which they have a financial interest.’

That makes sense on the surface, but, as always, there are broad strokes and there is nuance. In this case the issue is specialty drugs that aren’t available at community pharmacies. CMS’s interpretation says that those can’t be provided by, say, oncologists. The oncologists for their part say that sending scripts out to mail-order pharmacies causes delays and can even mean patients don’t get their meds because the drug is in shortage.

As one oncology-practice manager put it:

“I know my inventory level. I know how many weeks on hand I’ve got and I can work with the providers proactively before I run out. When you go to a mail-order facility, you’re just sending a prescription out. You don’t know.”

Of course both sides are making huge, definitive statements — ‘there won’t be any problem’ vs. ‘patients will be dropping like flies.’ (“They have ripped seamless medical care out of the hands of providers,” said one. Yet the law has been in place since 2001; enforcement was simply waived during the pandemic.)

A group of US representatives, including several from Georgia, is asking CMS to retract the guidance that’s causing the kerfuffle, and one patient-advocacy group is considering a lawsuit. Whatever happens, knowing the rulemaking process it’s unlikely to happen quickly.

Big cancer breakthroughs

A new drug against glioma

For patients with treatment-resistant glioma, there’s great news. A phase 3 trial of a new drug dubbed vorasidenib didn’t just work, it worked gangbusters.

The team found the drug vorasidenib more than doubled progression-free survival in people with recurrent grade 2 glioma with IDH1 and IDH2 mutations. Compared with people who received a placebo, those who took vorasidenib went for nearly 17 more months without their cancer worsening, delaying the time before they needed to begin chemotherapy and radiation.

Because glioma often strikes younger people, and the treatment for it can do nasty things to their brains, being able to delay or reduce traditional chemo/radiation treatment can make a huge difference. And vorasidenib is targeted only at cancer cells, so it doesn’t damage healthy ones.

With the phase 3 trial complete, FDA approval could (should?) be coming soon.

For some patients, huge lung cancer news

About a quarter of people diagnosed with lung cancer have a mutation in their EGFR gene. For those people, great news: “Taking the drug osimertinib after surgery dramatically reduced the risk of patients dying by 51%.

The survival benefit “was observed consistently” in an analysis across all study subgroups, including those with stage one, stage two, and stage three lung cancer. Chemotherapy had been given to 60% of those in the study, and the survival benefit of osimertinib was seen regardless of whether prior chemotherapy was received.

That’s a big enough deal that one researcher said osimertinib — aka Tagrisso — should become the standard of care for those patients.

Short Takes

Send in the bot

Endoscopy, schmendoscopy. Why stick a tube into someone when you can not just send in a tiny camera robot, but (now, thanks to George Washington University engineers) one that can be steered to the right location?

Think about this one for a bit

Intelligent minds take longer to solve difficult problems”.

[B]rains with less synchrony among various regions were prone to making hasty decisions without waiting for upstream brain regions to process the necessary information for solving the problem. However, for those with higher intelligence, their brain simulations took longer to solve the tougher tasks but committed fewer errors.