Posts in: news

With today’s Alphaville, I have never been more proud of paying for a (not cheap!) subscription. (ᔥJohn Gruber, who also provided some non-gift-link-requiring context)

Links for a Sunday afternoon, weekend print edition

Happy New Year, dear reader! Will 2026 be the year humanity makes it across the ravine without falling down? Let’s hope so.

(ᔥGIPHY)

A last-minute Financial Times gift link dump

Enjoy!

❄️ DC had its first snowfall today, which was so much earlier than usual that it surprised even some public school systems, which only had enough time to declare a 2-hour delay at most. DC Public Schools are operating on their regular schedule, because DC DOT can read the weather forecast and knows how to put salt on roads.

But it really wasn’t that early. We had November snow as recently as 2018 (November 15, 1.4 inches), so December 5 doesn’t even crack the the top 20. The earliest? October 10 1979, 0.3".

BREAKING: “rage bait” is the Oxford Word of the Year 2025. And before you comment:

We’re not rage baiting you by choosing two words—though that would be in keeping with the meaning of the term!

The Oxford Word of the Year can be a singular word or expression, which our lexicographers think of as a single unit of meaning.

I approve.

An interesting series of biotech headlines

All this for drugs that cost millions of dollars per dose from a company with $2B in revenue. Neutral people in the know have their opinions too. Know me by my enemies indeed.

Rejoice: our national nightmare is over, at least until March.

There is a major paradox underlying the US drug development strategy and if it is not resolved soon China will continue eating its lunch

The story of the United States Food and Drug Administration is a story of mismatches.

Mismatch one: cramming both food and drugs regulation into a single agency. Humans have been making food since the beginning of time — it is in fact one of our defining characteristics — and while the methods have become more and more intricate and our definition of food wider and wider to now include some decidedly unfood-like substances it is not a field where people expect too much experimentation and adding risk to production yields absolutely no reward to the end user. Drugs as used now — aspirin aside — are a modern invention. We learned about DNA less than a century ago and cell & gene therapy weren’t even an idea until late into the 20th century. An eye-blink, compared to food. And when it comes to production, risk is very much encouraged for those who need the drugs, particularly for rare diseases without approved therapies.

That is the second mismatch, one within the Drug section of the FDA: generic drugs that have been used for decades are more like food, unapproved, experimental treatments are quite the opposite. This is a source of constant tension that leaves much room for improvement. To be clear: Europe is worse. EMA requires drugs tested at any stage to be manufactured in a fully audited manufacturing facility; FDA allows for “phase-appropriate GMP compliance”. This still requires major investment, lest you leave yourself exposed to the whims of a random audit.

The third mismatch, one written up in STAT this morning, is one of management. Regulation of food and established drugs requires a certain mindset and personality type; regulation of experimental drugs is something else entirely. There is a paradox here: while most of FDA’s work is focused on the first two — it is the baseline activity absolutely essential for proper functioning of society — the focus of the public is mostly on the third. Unless, of course, something goes wrong which it amazingly rarely does considering the amounts of food consumed in this country. But the culture has been determined by this baseline activity, and I imagine people going to work at the FDA self-selected for that kind of culture: steady, stable, contemplative, detail-oriented and intentionally boring.

Which is to say, I am not at all surprised about reactions like this, where I can absolutely see both sides of the story and in fact agree with both. But the tie-breaker is this: the steady-as-she-goes leadership of what should be the leading edge of innovation has led to the US getting further and further behind China all while its taxpayers are bankrolling said innovation. This state of affairs is untenable and all the policy memos in the world won’t help unless this root mismatch is resolved.

If you figure out a way to do it — and do it with urgency — that does not involve breaking up the FDA into at least two pieces, do let me know.

FT links, (geo)political

While US groups have poured resources into gene therapy, many have been held back by soaring costs and regulatory hurdles in their home market. In China, by contrast, regulators have supported the field by allowing earlier human trials and more flexibility in how they are designed. […] But while Chinese regulators have nurtured innovation, low domestic drug prices have forced companies to look abroad to recoup investment. “One huge disappointment has been that the commercial sales for China’s drug sector have never bloomed,” said Loncar.

So let me see if I got this right: Americans are paying for health care out of their noses to finance the world’s medical innovation which nowadays mostly comes from China, the citizens of which have among the lowest medical costs in the world. Someone here is being played.