A moment for the victims

For all the good the new weight loss drugs are doing for patients, take a moment to shed a tear for the victim in all this: SlimFast, which has seen its sales plunge 30% from 2022 to this year.

Welcome, future GPhA members!

Behold your future coworkers

The UGA College of Pharmacy brought 147 new students into the fold at this year’s White Coat Ceremony — which just so happened to feature GPhA Interim CEO Mahlon Davidson (UGA ’82).

Welcome, one and all!

Vitamin K takes asthma away (maybe)

Someone who low levels of vitamin K is more likely to suffer from asthma, COPD, or simply wheezing. That’s the conclusion from a group of those shifty Danes who studied 4,000 other shifty Danes, conducting tests of lung function and comparing them with participants’ vitamin K levels.

Lower vitamin K was associated with lower lung function. Note the word associated; the authors pointed out that the study “only found an association between vitamin levels and lung function; it couldn’t prove cause and effect.”

Still, they say, it’s a connection worth investigating. In the meantime, if you have trouble breathing, hit those leafy greens, vegetable oils, and whole-grain cereal.

(Side note: Vitamin K again? Yep. Back in May we told you how vitamin K might protect against diabetes.)

Insurers balk at Lemquebi’s price

Medicare might be planning to cover Eisai’s new Alzheimer’s drug Leqembi (with restrictions), but private insurers are balking. It’s not just the $26,000 per year price tag (plus the cost of scans and repeat visits), it’s the dangerous side effects and the fact that even when it does work, the real-world effect isn’t huge.

Or, as one insurer’s spokesperson put it, “the existing evidence does not allow for conclusions to be drawn about the safety and effectiveness of Leqembi.”

Speaking of unclear benefits….

Cancer drugs (Swedish researchers explained) are often approved based on lab tests — regulators want to get them to patients quickly. But when they looked at the real-world data, they found that a lot of those drugs don’t have much of an effect.

“We have shown that the majority of the drugs launched with limited evidence still lack clear evidence of how they actually affect survival and quality of life in patients.”

In fact, of the 22 drugs they checked, only 7 really worked (“the treatment either improved quality of life or increased life expectancy.” The other 15? “[R]andomized controlled trials failed to show any such effect, or there were no results from these trials.”

We need narrower racial categories

When studies considers patients’ race, they might be painting with too broad a brush. Essentially, lumping Chinese, Indian, Japanese, and Korean people into the Asian category can hide important distinctions between the groups, say Cornell researchers. Ditto for, say, Black including people from Africa and the Caribbean, or White including Canadians and Russians.

Often, there were greater differences among subgroups within the same race category than between the broad race categories themselves.

Warning! Warning!

FDA slaps AZ for misleading claims

The FDA is Not Happy at All with how AstraZeneca’s sales material represents its Breztri Aerosphere inhaler. It send the company a sternly worded letter.

According to the FDA, the document includes the “prominent headline claim” about a difference in time to all-cause mortality between the Breztri and control cohorts in a chronic obstructive pulmonary disease (COPD) clinical trial.

In fact, the agency says, there’s no data showing that Breztri had a positive impact on all-cause mortality. The company has 15 days to submit a “plan for discontinuing use of such communications, or for ceasing distribution of Breztri” or Steps Will Be Taken.

Even podcasts aren’t immune to the long arm of the law

Meanwhile, across the pond, the UK’s Prescription Medicines Code of Practice Authority (PMCPA) has accused Novartis of playing fast and loose with efficacy and safety claims of Entresto in a podcast aimed at heart failure specialist nurses. No, said the agency, there’s no evidence Entresto can increase energy levels as the company suggested.

[T]he PMCPA determined that Novartis “reduced confidence in, and brought discredit upon, the industry.” This verdict amounted to a breach of the gravest nature, falling under Clause 2 of the ABPI Code, the most significant breach possible.

Crazy science story of the week

Researchers at UC Berkley were able to recreate Pink Floyd’s “Another Brick in the Wall, Part 1” by monitoring the brain of a patient who underwent brain surgery, playing back the song based on the patient’s brainwaves.

It suggests that in the future, a brain-computer interface wouldn’t have to sound like Stephen Hawking.

No word on whether the patient also watched “The Wizard of Oz.”