Who I'm Reading Today

https://www.science.org/content/blog-post/complete-regulatory-chaos

It is next to impossible to keep up with all the chaos in the Trump administration’s staffing of the public health agencies (NIH, FDA, and all the ones under them). I haven’t tried to cover it all blow-by-blow, because it would exhaust me and exhaust you the readers, and to what end? You can make out the main points of the Trump/RFK Jr. approach pretty easily.

One of those is clearly, obviously, a multipronged attack on the practice of vaccination. Every new appointment at the CDC seems like yet another “longtime skeptic” or “maverick thinker”, but what they all have in common is a long public record of anti-vaccine activism. It comes from all sorts of directions: claims of covered-up vaccine damage or deaths, assignment of every possible harm to vaccines while ignoring their benefits, just-asking-questions approaches to every phase of the development and approval process, attempts to repeal mandatory childhood vaccination laws and to mess with the childhood vaccine schedule in any fashion that can make it more likely that fewer children get vaccinated, attempts to rework liability shields for vaccine manufacturers, generalized spreading of fear and uncertainty. . .the lot.

Everything points in the same direction, constantly. We can wonder about where this relentless hostility to the very idea of vaccinating children comes from (I have a lot of ideas myself). Perhaps some of it, in some cases, is a sincere (but extremely misguided) belief that vaccination really does harm children and the entire population, instead of the actual situation (out here in reality) where it saves lives and mitigates suffering. But some of it is just a grab for fame, power, and (let’s not pretend otherwise) money. RFK Jr. himself has made millions and millions of dollars being a loud public anti-vaccine advocate, and there’s a lot more cash out there to be scooped up. My own instinct is to impute no reasonable or honorable motives to the man at all - his conduct over the years doesn’t argue for either.

This isn’t just my complaint, obviously. Reliable observers all over the biopharma world are aghast at what’s happening. Here’s Steve Usdin at BioCentury on the latest vaccine news, here’s Stat on RFK Jr. and on vaccine policy, here are editorials and expressions of concern at the New York Times, at CIDRAP, at the Guardian, at the Wall Street Journal. . .and when those last two are lined up on the same side, you have to realize that there’s a problem.

Meanwhile, at the FDA, confusion reigns. Which is exactly what you don’t want in such a regulatory agency. The FDA needs clarity and consistency, firmness of purpose and to ability to let everyone know where everyone stands. Clinical trial designs, manufacturing oversight, fast-track designations, drug approvals (and conditional approvals and rescinded approvals). . .there is no room for winging it. Drug development is a long and hideously expensive task with plenty of twists and turns, and without clear well-thought-out regulatory processes it can rapidly descend into a nightmarish free-for-all that wastes time, wastes money, and endangers the public. A big part of my loud objections to some of the FDA decisions and approvals over the years has been when they don’t seem to be following their own rules, because that’s such a dangerous way to work.

Welcome to 2025, then. I can’t tell what the hell is going on, and I don’t think anyone else can either. Vinay Prasad was apparently pushed out in late July, then came back two weeks later under circumstances that have still not been explained. George Tidmarsh was appointed to lead CDER (the Center for Drug Evaluation and Research) in July, but was forced out in early November amid reports that no one was interested in taking over the job at all given the chaos. Back in mid-November Richard Pazdur was announced as the choice to fill that role, a move that many people found surprisingly sane, given his long track record at the agency. But no fears about that: Stat just broke the news this morning that Pazdur is apparently planning to leave the FDA entirely (according to two sources who seem to have heard his announcement earlier today). 

This is all perfectly in line with the rest of the Trump administration: we are being lead by a swarm of incompetent ideologues and ignorant grifters who are relentlessly ruining everything they touch. Every part of the federal government is being degraded right in front of us, and it’s happening with the smiling approval of the most useless Congress in the country’s history. I write about the biopharma industry here, so I’ve focused on that, but the rot is everywhere. Speed the day when we can start cleaning it up.

https://www.science.org/content/blog-post/complete-regulatory-chaos