“Collaborated” is such a strong word…

Remember the Aduhelm brouhaha^* — the FDA’s advisory committee voted against Biogen’s Alzheimer’s drug approval, but the FDA gave a thumbs-up anyway, despite serious questions about Aduhelm’s effectiveness?

Now the House Oversight and Reform Committee has an explanation:

[[H]igh-level engagement between Biogen and the FDA in the months preceding the approval, including at least 115 meetings and “substantive” email exchanges, that exceeded the interaction normally seen between sponsor and regulator.

Or, as one member put it, they collaborated; the phrase to google is “regulatory capture.”

^* Kerfuffle to those born before 1970

They’re not taking Paxlovid

If you test positive^*, treatment is easy — and smart. Paxlovid. It’s the simplest, best way to keep out of the hospital or the sick bed. Pharmacists can even prescribe and dispense it.

And yet, people aren’t taking it … only 11 percent, per a recent study. And prescribers (including pharmacists) aren’t prescribing it. The culprit: ‘confusion and unclear guidance.’ Not for the patients — “Thog postive! Thog want Paxlovid!” — but for prescribers.

Officially, only people at high risk are eligible, but “high risk” is a pretty wide range. Physically inactive? Bingo. But there’s a long list of drugs that interact with it, and conditions like kidney disease that make Paxlovid contraindicated.

Result: Reluctance by pharmacists, and physicians are often too busy to go through the checklist — and “a tremendous lost opportunity.”

(Shout-out to GPhA’s Ira Katz, who’s featured in the article.)

^* We can still get away with saying “test positive” without specifying what for.

Here come the price hikes

It’s a new year, and that means pharma companies have decided their existing products are worth more, so they’re raising their prices. (But only up to 10%, of course. More than that would be impolite.) They need to pay for stockholder dividends research and development, of course*.

For 2023, drugmakers have decided to increase prices on at least 350 drugs.

Notable increases expected include 9% price hikes on Bristol Myers Squibb’s personalized CAR-T cell therapies Abecma and Breyanzi, both of which were already more than $400,000 for the blood cancer treatments. […]

Increases for Pfizer include a 6% rise on the cost of Xeljanz, a treatment for autoimmune diseases including rheumatoid arthritis and ulcerative colitis, and 7.9% increases on cancer drugs Ibrance and Xalkori. […]

AstraZeneca is set to raise prices in the 3% range on blood cancer treatment Calquence, non-small cell lung cancer drug Tagrisso, and asthma treatment Fasenra.

^* Except when publicly funded universities do the work

When ketamine works

Ketamine has shown a lot of promise for treating depression … except when it doesn’t. It seems to work for some people but less for others, and it’s not clear who is whom.

But the folks at Baylor College of Medicine have found a trend among people with treatment-resistant major depression. Some respond quickly and robustly, some took a while to notice a difference, and some didn’t get much benefit at all.

There was one common factor among those who had the best experience:

People with severe depression who reported a history of childhood abuse and trauma were among the most likely to respond quickly and robustly to ketamine.

(Why those people get such a benefit isn’t clear, but it might (they think) have to do with having become overly sensitive to certain stimuli.)

A new kind of HIV treatment

Today’s “game-changer” is a drug that tackles HIV. Even better, it’s not in the lab — it was just FDA approved.

Gilead’s Sunlenca, an antiretroviral, only needs to be taken twice a year. It’s designed for patients who don’t respond to other treatments, but it’s also an entirely new class of drugs called capsid inhibitors that attack HIV all along its lifecycle. Another benefit: It’s a subcutaneous injection, so home injections could become a thing.

In a clinical trial, 83% of patients taking Sunlenca with a combination of other drugs achieved an undetectable viral load after about a year.

The downside: Gilead charges $42,250 to start the therapy, and then $39,000 a year for maintenance shots. Whether non-Medicare/Medicaid patients can afford it is still up in the air.

And then there were nine

Nine major food allergens, that is, starting this past Sunday, when sesame was added to the FDA’s official list.

[F]oods containing sesame will be subject to specific food allergen regulatory requirements, including labeling and manufacturing requirements.

Existing products don’t need to be removed or relabeled or anything, but look for sesame warnings to start appearing. And as I’m sure you’re curious, the other eight are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

A two-front war on pancreatic cancer

Treatments for major conditions start with preclinical models — like the latest hopeful one for pancreatic cancer. Instead of targeting T cell or myeloid-suppressor cell checkpoints, the three-prong therapy out of the University of Texas targets both.

In basic terms, they’ve discovered that, despite the conventional wisdom, pancreatic cancer is vulnerable to immunotherapy — it just has to hit multiple targets.

In less basic terms, they targeted three proteins — 41BB, LAG3, and CXCR2 — that were found in exhausted T cells, and that had been produced by the tumor’s “immune microenvironment.” By limiting those proteins, the T cells were better able to attack the cancer.

The immunotherapy agents they tested are currently being tried individually, meaning the first steps toward clinical trials are already underway.

Your papers, please

When it comes to faxes, Forbes is asking the wrong question. It’s not “Why are fax machines still in use?” The question is “Why are paper records and files still in use?”

Sure, it’s fun to pick on the fax machine, but the reality is that they work, they work simply and easily, they’re secure, and they’re the fastest and easiest ways to move paper records.

So why do we still have paper records? There are pluses and minuses, and that’s another discussion. But picking on fax machines is choosing the wrong target.

The Long Read: What Have We Learned for Next Time? edition

The most important takeaway from the Covid-19 pandemic is to figure out what went wrong and blame the Other Side for it to score political points.

But for the handful of people left who think it’s important to actually learn from the pandemic, Smithsonian magazine skips the blame part and looks at what we can (and need to) do better next time.