Lowering the bar for drug approvals

Since the passage of the 21st Century Cures Act in 2016, the FDA has been approving drugs, especially cancer drugs, faster — that was the idea. But it’s also been relying on less data to do that, or it’s not sharing that data with the public as it should.

That’s the conclusion of researchers at Stanford and Oregon State universities, who examined FDA approval data from 2017 and 2022.

One interesting tidbit they found: Although drug companies conducted an average of 5.8 studies per drug, approval was based on 1.4 studies.

For many drugs that have been tested in multiple clinical trials, pharmaceutical companies are only required to share the results from two trials, leaving questions about why they chose those two for submission and what happened in the other trials.

The other info is sometimes made publicly available later, but not always, despite the fact that “Everything is supposed to be transparent with this FDA process.”

Semaglutide’s next trick

A new study out of Kansas City (MO) found that semaglutide https://www.theguardian.com/society/2023/aug/25/weight-loss-drug-semaglutide-reverses-heart-failure-symptoms-study. And it’s not just by helping them lose weight.

The medication “produced large improvements in symptoms, physical limitations and exercise function, reduced inflammation, and resulted in greater weight loss and fewer serious adverse events as compared with placebo”.

Treating Tylenol poisoning

An expert panel has published the first clinical guidelines for treating acetaminophen poisoning. “They recommend an acetylcysteine regimen of at least 300 mg/kg during the first 20 to 24 hours” as well as reassessing patients after the first round of treatment rather than just sending them home.

Not-so-fun fact: “More than 80,000 cases involving an acetaminophen product were reported to U.S. poison control centers in 2021.”

Yeast makes drugs (and she made the yeast)

A Stanford professor’s company has bioengineered yeast to make drug ingredients. And they make them a heck of a lot faster than the current ‘grow them in fields’ method. It’s not just in the lab, now — it’s actually producing ingredients at industrial scale.

Last week…

… the company announced it has completed its first commercial-scale fermentation run, which resulted in the production of 116,000 liters of thebaine, a key ingredient for several essential drugs. And rather than a turnaround time of a few months, Antheia made the chemical in about five days.

Nor is it a one-trick pony. Antheia has more than 70 other ingredients in its pipeline for different types of drugs, including oripavine (for pain-management drugs) and scopolamine (anti-nausea).

A supplement for hearing loss?

If you have older mice suffering from hearing loss, there’s some potentially good news out of Argentina. It seems that one of the cause of hearing loss is a lack of cholesterol in the inner ear. (Who knew?)

Pharmacology researchers in Argentina figured if you could increase that ear cholesterol, the amplification cells could get better at their job.

They decided to use phytosterols — plant-based compounds similar to cholesterol — because they can cross the barrier into the brain. And what d’ya know, it worked. The mice who got phytosterols saw their hearing improve.

And guess what? Phytosterols are available as OTC supplements. But before you rush to stock ’em, keep in mind that this is just a lab-based experiment. More trials will be needed.

Non-pharma cool health stories

Wild medical science marches on

Brown U researchers connected a computer to the brain of a woman with ALS — she cannot speak or even use the muscles in her mouth — and typed out her thoughts at 62 words per minute.

(No, Mr. Policeman, it doesn’t read her mind. She has to deliberately think as if she’s saying the words, and an AI processes her neural activity.)

Turtle danger, redux

We told you back in 2021 not to kiss your pet turtles. And yet here we go again — this time with baby turtles.

[J]ust because a turtle has a shell that’s over four inches long doesn’t mean that you can start nuzzling with the turtle or sharing noodles with the turtle à la “Lady and the Tramp”.