Posts in: news

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.

Weekend links, MSM edition

Gift links for the last 3 — enjoy.

Monday links, all heavy and will take the better part of the week to digest

  • Nassim Taleb: The World in Which We Live Now. This is the essay version of his talk at the Ron Paul Institute, and much easier to follow.
  • Miloš Vojnović: The 2020s: The Age of What?. My suggestion: despair.
  • Leo Tolstoy: A Confession. Serialized by Cluny Journal, two of 6 parts out as of this morning.
  • Tanner Greer: Bullets and Ballots: The Legacy of Charlie Kirk. A viewpoint about a person of whose existence I wasn’t even peripherally aware until last week: “I do not think liberals, progressives, or even older conservatives understood the amount of slime thrown at Kirk by those to his right. His eagerness to work with the new establishment inside established political forms, his program for the right’s spiritual renewal, and his generally pro-Israel line made him a constant target of Nick Fuentes and the “Fuentards” who follow him. His commitment to populist coalition-building made him an enemy of people like Laura Loomer, who described Kirk as “a political charlatan, claiming to be pro-Trump one day while he stabs Trump in the back the next” just a few weeks ago.” If you are known by your enemies…
  • Ernie Smith: Saying Exactly What You Mean. Another viewpoint, but more so about Jesse Welles whose song [“Charlie”][5a] is very good.
  • Claude Taylor on X: This is still the best reading of all this I’ve seen. I have no idea who this is-but (I think) he’s got it. I agree! The commentator’s name is Aidan Walker and he has a blog about memes to which I am now subscribed.

A few quick news hits from the FT

All gift links. Enjoy.

The FT Editorial board says it’s time to stop indulging Serbia’s authoritarian president:

America seems to have left the Balkan pitch for now. But the UK and the EU have not. They should act and use their economic leverage. If they do not and Serbia heads further down the authoritarian path, it will be not just Vučić but also his gaze-averting western backers who are to blame.

“Economic leverage” sounds suspiciously like sanctions, which would be the exact wrong move to take and would only strengthen the president’s hand. Just ghost him — it would infuriate his small narcissistic mind.

Alex Tabarrok wrote a brief comment on why America always wins in the global superpower game:

Double down on immigration, entrepreneurship, innovation, building for tomorrow, free markets, free speech and individualism and America will take all new competitors as it has taken all comers in the past.

Funny how each and every of these reasons of America’s dominance is not only under threat — they always have been — but is being actively dismantled by the state itself. This time may truly be different.

With successes like these, what happens to the failures?

Whatever you think of medicalization of moderate obesity, the GLP-1 inhibitors semaglutide and tirzeparide (aka Ozempic, Wegowy and Zepbound) are truly groundbreaking. It takes a lot for me to admit something approaches imatinib in innovation and importance, and they are there! Incredibly, the drug companies that developed them are considered losers in the upside-down world of American finance:

Since their peak last year, the decline is more pronounced. Novo Nordisk has lost $367bn in value since its peak in June 2024, a fall of more than two-thirds, while Lilly has fallen 29 per cent from a record valuation last year, wiping $250bn off its market capitalisation.

In a decision that was short-termist and reactionary to the extreme, Novo Nordisk even fired their longstanding CEO over it.

The kicker comes from a healthcare fund manager quoted near the end of the article:

“If you’re a generalist investor, why are you putting money here, versus buying an AI stock, [given] the headwinds of both tariffs and the most favoured nation policy?” he added.

What are we even doing here?