Polypharmic kids

Of kids taking two or more medications, what percentage do you think have drug-drug interactions? How about 21.4%?

Yep, more than 1 in 5. Researchers at Children’s Mercy in Kansas City (Mo.) looked at the health data of more than 780,000 children who were taking two or more outpatient meds and had at least one trip to hospital.

Of those, 21.4% “experienced one or more major DDI [drug-drug interaction] exposures.”

The biggest culprits were clonidine as well as psychiatric and asthma medications, and the most common problems were “increased drug concentrations, central nervous system depression,” and irregular heartbeat. So maybe keep an eye out.

A small correction

Yesterday we wrote about hospitals in some states reinstating mask requirements. “None of those states are among those with the highest level of respiratory virus activity,” we said. WRONG.

If our geography knowledge had been better, we would have realized that North Carolina has both the highest level of activity and some hospitals requiring masks.

Senators target inhaler prices

Some US senators are Not Happy at All with the prices of asthma inhalers — specifically, how companies are gaming the patent system to keep generics out of the market. So they’ve written a strongly worded letter (13 pages!) to let As­traZeneca, Boehringer In­gel­heim, GSK, and Te­va know how they feel.

“It is un­ac­cept­able that Te­va is charg­ing Amer­i­cans with asth­ma $286 for its QVAR Redi­Haler that costs just $9 in Ger­many. It is be­yond ab­surd that Boehringer In­gel­heim charges $489 for Com­bivent Respi­mat in the Unit­ed States, but just $7 in France.”

They gave the companies un­til Jan. 22 to explain how they set their in­haler prices.

The Long Read: Unheard Warnings edition

While we’re on the subject of asthma, read about how even a boxed warning on a drug didn’t get patients the information they needed.

The F.D.A.’s handling of Singulair illustrates systemic gaps in the agency’s approach to addressing troubling side effects from medicines approved long ago — and to warning the public and doctors when serious issues arise.

Respiratory update

Flu and Covid cases are still rising and will probably do so for at least several more weeks. That is all.

Drugs to fall on deaf ears

Loud music can hurt your hearing, and you may have assumed it was due to physical damage of the bits inside your ears that can’t be undone.

Guess what? It turns out the damage is more complex, but there could be a pharmaceutical treatment.

UC San Francisco researchers were investigating mutations in a gene called TMTC4 that can lead to hearing loss. What they found was that loud noises caused the same effects as the TMTC4 mutation. In both cases, hair cells in the inner ear were flooded with excess calcium, which activates what’s called the unfolded protein response (UPR) killing the hair cells and leading to hearing loss.

In other words, it’s not simply physical damage to the ear that causes hearing loss, it’s this unfolded protein response. And that means, “that the UPR is a genuine target for preventing deafness.”

Even better, there are already several drugs that block the UPR and can stop genetic hearing loss in animals. But no one bothered to test those for noise-related hearing loss in humans. That might change….

No more fine “print”

After listening to public comments, the FDA has finalized its guidance for direct-to-consumer drug ads. The goal is to make sure that warnings aren’t in tiny print or a rushed voice over — that they’re presented in a “clear, conspicuous, and neutral manner.”

No more technical jargon. And for audio ads…

FDA asks that [manufacturers] take into consideration the volume level, articulation and pacing of the audio to ensure the information is understandable. Similarly, when presenting ads on TV ads the agency states any accompanying text needs to be displayed long enough so it is easily read and that it remains on screen for as long as the corresponding audio.

(Obligatory reminder that only the US and New Zealand allow direct-to-consumer drugs ads.)

Drug pricing news

Canada on Florida’s import plan

In the wake of the FDA’s granting Florida the right to import (some) drugs (under some conditions) from Canada, the Canadians have weighed in. Innovative Medicines Canada — which represents most of the Great White North’s pharmaceutical industry — is sorry to say … no.

“Canada simply can’t supply drugs to Florida, or any other U.S. states, without significantly increasing the risk and severity of drug shortages nationwide. The U.S. market is nearly 10 times bigger than Canada’s, and allowing drugs that were intended for Canadians to be exported to the U.S. would harm Canadian patients and disrupt our health-care system.”

America’s low prices (!)

Americans pay the highest prices in the world for brand-name drugs, but when it comes to generics, the opposite is true. They’re super cheap — and that’s a big reason behind drug shortages.

Competition has driven the prices so low, there’s simply not enough profit to be made, at least in the US. As one boffin^* put it, “There’s been a lot of offshoring because there is a drive to get the drugs made as cheaply as possible, so the manufacturer has a large incentive to go seek lower-cost environments.”

Those environments are usually China and India, which are sorta-kinda fine for now, although…. “It’s a potential future risk. But it’s a potentially massive risk.”

^* Word of the day!