FDA at work

Alzheimer’s drug gets nod, but not everyone is happy

In a controversial decision, the FDA has approved Biogen’s aducanumab Alzheimers-drug. Controversial because it’s questionable how well it works — although it’s not unsafe.

Biogen’s drug had been hailed by patient advocates and some neurologists eager to have an effective option for patients with the lethal disease. Other doctors said clinical trial results were inconsistent and more proof was needed.

Here’s a tidbit: “The FDA said Biogen must conduct a post-approval clinical trial to verify the drug’s clinical benefit.” As friend-of-Buzz quipped, “Aren’t they supposed to do that first?”

Read about the controversy (written before the approval) here.

Weight loss drug approved, and everyone is happy

The agency also approved semaglutide, the once-weekly injection for chronic weight management in obese adults. That’s been shown to have amazing results, so this wasn’t unexpected.

Warning: Some news stories call it a “game-changer.” Ugh.

Quickie poll

Buzz often includes non-pharmacy health/medicine stories. What do you think? |SURVEY: I think you have a decent mix of pharma and other medical stories. | |SURVEY: Honestly, I’d prefer you stick to mostly pharmacy stuff. | |SURVEY: I read pharmacy news all the time, I’d like MORE stories from other practice areas. | |SURVEY: I have no opinion either way. I just enjoy taking surveys. |

Buzz often includes non-pharmacy health/medicine stories. What do you think?
*|SURVEY: I think you have a decent mix of pharma and other medical stories. |*
*|SURVEY: Honestly, I'd prefer you stick to mostly pharmacy stuff. |*
*|SURVEY: I read pharmacy news all the time, I'd like MORE stories from other practice areas. |*
*|SURVEY: I have no opinion either way. I just enjoy taking surveys. |*

Our chief weapon is surprise! Surprise and fear!

Who doesn’t like to scare a little kid? Of course, not all of them have the same reaction to fear as you might hope, but it turns out there’s an interesting reason: gut bacteria. Yeah, them again.

Researchers from Michigan State University and UNC did some tests on 30 infants (with parents’ consent, of course) after sampling their gut bacteria. They found that the types and amount bacteria determines how the kids react to being scared.

Compiling all the data, the researchers saw significant associations between specific features of the gut microbiome and the strength of infant fear responses. For example, children with uneven microbiomes at 1 month of age were more fearful at 1 year of age. Uneven microbiomes are dominated by a small set of bacteria, whereas even microbiomes are more balanced.

There’s a Goldilocks zone for fear, it seems. If kids are too afraid “they may be at heightened risk to develop anxiety and depression.” But if they have “exceptionally muted fear responses,” you might be looking at the next Genghis Khan* — a kid who “may go on to develop callous, unemotional traits associated with antisocial behavior.”

* Yes, we know his name was Temüjin. Don’t be That Guy.

Good news for triple-neg

Tests on AstraZeneca’s Lynparza found that, for patients with triple-negative breast cancer — the kind that’s almost impossible to treat — it can extend their lives and possibly keep the cancer from recurring.

Results show 86 percent of the patients taking Lynparza were still alive with no cancer recurrence after three years, in comparison to 77 percent of the placebo group. Overall, study authors find Lynparza reduced the risk of cancer recurrence by 42 percent.

What brown can do for you

When it comes to fat, white is bad and brown is good. Pretty simple. (Technically it’s white adipose tissue and brown adipose tissue, but we’re not messing with “WAT” and “BAT” when we have “fat”.)

Brown fat is very good at turning sugar into heat, so it’s been a target for weight loss and diabetes treatment. In fact, some folks are skinny simply because they have a higher ratio of brown to white fat. (shakes fist)

All that said, University of Texas researchers have found that mice with higher levels of a protein called perilipin 5 (PLIN5) in their brown fat cells maintained a healthier glucose level. And when they increased that PLIN5 level even more, “the animals maintained significantly lower blood sugar concentrations and higher insulin sensitivity.”

Even better, though, is that increasing the brown fat’s PLIN5 levels had a side effect: It reduced the size of the white fat cells, and also cut down on inflammation. It was as if when the good fat cells were pumped up, they intimidated the bad fat cells into shrinking and shutting up. No complaints.

FYI: Fisher-Price recall

The company is recalling its 4-in-1 Rock ’n’ Glide Soothers because they can kill children.

The Long Read: This Ain’t Sherlock Homes edition

We all read that people — experts in these things — are trying to discover the origins of Covid-19. Did it jump to humans naturally, or were scientists in Wuhan working with it and had an accident? In movies, the answers are easy to find. In real life … not so much. Read on, in “How virus detectives trace the origins of an outbreak – and why it’s so tricky”.