At the very start of the textbook Fundamentals of Clinical Trials the authors make a distinction between clinical trials — comparing two or more different interventions — and clinical studies, which merely describe an intervention without comparing it to anything. So, there can be no such thing as a “Phase 1 trial”, since they typically involve a single drug at different doses and schedules. The only true trials, according to the authors, would fall under Phase 3, or Phase 2b at the earliest.

This is stupid, misleading, and not at all how the words “trial” and “study” are used by anyone else, including the biggest and most important drug regulatory agency in the world. There are many such pointless exercises of professorial power in medicine, including my favorite: whether the correct pronunciation of “+” in “7+3” is “plus” or “and”. They amount to nothing more than purity tests that award the wielders of the right language a false sense of precision. As Nassim Taleb wrote, nitpicking is the enemy of thought.

The rest of the book is good enough, but more on that later.

People enthralled with Microsoft’s innovation streak must never have used Teams. Like nails on a chalkboard.

Yes, yes, America has terrible health care — even a tech podcast says so — while paying an order of magnitude more for it than other rich countries. But hear me out: what if the costs are so high because Americans are (unsuccessfully) trying to buy their way out of poor policy decisions, from dependence on cars, to the early 2000s' promotion of opioids, to the widespread availability of cheap but nutrient-less calories, and no amount of fiddling with who pays for what in healthcare will be able to fix that?

Which is to say: it’s fine to look at specific costs and specific outcomes — I have done so myself — but what exactly is the action item after reading a report like The Commonwealth Fund’s cited by Ars Technica?

📺 I was 10 when The X-Files came out and watched it week by week through hyperinflation, school closures and bombings. Now that we have a 10-year-old at home I thought it would be a good time to revisit the series, and it has aged very well indeed. This will be fun!

After a few months of intermittently kicking the tires on Dave Winer’s FeedLand, I’ve finally had the time to port over a few feeds from my preferred RSS reader. The wonderful thing about FeedLand is that you can easily follow my feed categories and read posts without having an account (which is fortunate, since new signups on Winer’s own server are on hold). The full list of feeds is here. There is even a feed of posts I liked! It’s feeds all the way down.

The Science category has your usual suspects but I had to dig deep for Medicine since many of the blogs I follow haven’t been updated in years and others have turned into HuffPost-level text mills. Fortunately, Substack enabled a resurgence of medical writing, with feeds enabled by default.

Did I mention NetNewsWire is a free, open source RSS reader available on MacOS and iOS, and can sync via iCloud? For the anti-Apple readers, Feedly is there, I guess?

The National Cancer Advisory Board is as big of a deal as it sounds, but have a look at their Charter — Description of Duties in particular — and try not to yawn. I suspect whoever wrote this also writes grant application instructions. May this in part be why science is bogged down?

In any case, the Board meetings are open to public. The next one is on February 9, 2023 at 1:15pm EST and can be viewed at videocast.nih.gov. That website is itself a trove of excellent recordings unrelated to federal body deliberations: just last week there was a lecture on bacterial immune systems, here is my old boss talking about interleukin-15, and hey what’s this?

Warning, it’s a press release:

Gaithersburg, MD, January 31, 2023 – Cartesian Therapeutics, a fully integrated, clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases and cancer, has dosed the first participant in its Phase 2b randomized controlled trial (RCT) for generalized myasthenia gravis (MG), an autoimmune disorder that causes muscle weakness and fatigue. The RCT will evaluate the efficacy and safety of the company’s lead asset, Descartes-08, a first-in-class, RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T).

To the company’s knowledge, this is the first placebo-controlled study of an engineered cell therapy, and the most advanced investigational cell therapy in clinical development for any autoimmune disease. Descartes-08 is administered over 6 weekly outpatient visits and requires no preconditioning chemotherapy.

The manuscript from the open-label study is almost done, but some of the data was presented back in September 2022 (and available on YouTube). I also talked about the study in an MGFA webinar.

RCTs FTW.

This April will be 10 years since Elsevier aquired Mendeley, up until then the best reference manager around. And it took longer than expected, but it looks like they finally killed it.

To all the Mendeley refugees: Endnote is just as bad, and in many ways worse. Get Zotero.