FDA’s half-full bias

A former FDA advisory committee member was concerned that the agency overruled the committee’s recommendation against Aduhelm approval. He quit the committee over it, but he also got curious. How often did the FDA overrule its advisors?

So he looked at 11 years worth of data. The answer was striking, and it showed how the agency has a strong bias towards approval.

• When the committee voted for approval, the FDA agreed 96.6% of the time.
• When the committee voted against approval, the FDA only agreed 66.6% of the time.

As one commentary writer put it:

“The FDA is no longer asking committees to determine whether a drug should be endorsed, she said in an interview. The advisory panels instead are being used to guide the agency toward easier paths to approval.”

GOP offers drug-shortage plan

As the reality of drug shortages — and our reliance on our Chinese friends — sinks in, legislators from both parties are on the case. The latest ideas come from Republicans on the House En­er­gy and Com­merce Com­mit­tee.

Although they blocked the Democrats’ plan to tackle shortages, they have their own: the Stop Drug Short­ages Act. It’s got a bunch of pieces including…

• Requiring generic drug makers disclose information about their active-ingredient suppliers
• Allowing 503B compounding pharmacies to compound drugs within 30 days of it going into shortage
• Require the FDA test conducting pre-ap­proval in­spec­tions for new man­u­fac­tur­ing fa­cil­i­ties in the US, which would hopefully speed up the li­cens­ing process.
• Exempt some makers of gener­ic, ster­ile in­jecta­bles from 340B rebates
• Cap some Medicaid rebates
• Reestablish Medicare rebates for drugs coming out of shortage

After a few weeks of feedback they intend to offer it up as a bill.

Let it out

Answering the question “Is venting good for your health?” the American Heart Association offers this helpful tidbit: Choose your audience wisely.

(The answer is it can be good as long as you vent to someone receptive. Maybe write stuff down instead.)

Magic mushrooms ‘reset’ anorexic brain

Anorexia is notoriously difficult to treat with medication because it’s “ego-syntonic,” meaning there’s a strong psychological component. But UC San Diego researchers say their small study found that a bit of psilocybin might do the trick.

(Key word: small.)

Participants reported positive changes three months after dosing, with some demonstrating clinically significant reductions in eating disorder psychopathology. Some participants had a robust positive response to just a single-dose treatment. No serious adverse events were reported.

They think that psilocybin gave the patients a dose of “cognitive flexibility” that could “disrupt eating disorder related preoccupations, rigid thinking styles and entrenched behavioral patterns.” But as always, more research is needed.

It’s so crazy it just … might … work

Strawberries vs dementia

“Eating strawberries daily may improve cognitive function in older adults,” according to a new study out of San Diego State University, “as well as lower blood pressure and boost antioxidant capacity.”

After strawberry intake, cognitive processing speed increased by 5.2%, systolic blood pressure decreased by 3.6% and total antioxidant capacity jumped by 10.2%. Waist circumference decreased by 1.1%.

Caveat: The study was of 35 people (healthy older men and women). They ate two servings worth of freeze-dried strawberry powder per day for 8 weeks. So yeah, larger studies will be needed.

Kombucha vs glucose

Got diabetes? Maybe drink some kombucha^*. That’s the conclusion from a small “feasibility” trial —just 12 people — led by Georgetown health researchers.

People with type 2 diabetes who drank the fermented tea drink kombucha for four weeks had lower fasting blood glucose levels compared to when they consumed a similar-tasting placebo beverage.

As always, “A lot more research needs to be done, but this is very promising.”

^* “A sweet, fizzy drink made from bacteria, yeast, sugar, and tea”

Pecans vs obesity

Eating pecans daily — and pronouncing the word properly — can prevent obesity, fatty liver disease, and diabetes, according to a study out of Texas A&M. Amazing! Fun fact: “This study was supported by the Texas Pecan Board.”

The Long Read: Conflict of Interest edition

A New York fertility doctor likes to prescribe DHEA supplements for his older patients — despite scant evidence that it works … and that he owns the company that sells the supplements.