Great, now I have to start proof-reading any communications I get from the FDA to make sure it didn’t hallucinate a scientific article in the citations. There’s going to be so many Vegetative Microscopy proposals.

If you’re working on a budget like I was when starting out on my own, I recommend your first purchase to be a bed frame. You can use Ceaigslist / FB marketplace to find some really cheap used options. From there, you can start buying (used) furniture that matches the bed frame. Personally, I needed a nightstand immediately after the bed frame because I wanted to put my glasses somewhere.

Good point, I’m assuming all monitors are as good as mine.

Fair point, but a lot of the article talks about how many studies aren’t meeting all four pillars of clinical trial design - that’s where my issue comes in, I think reporting that X% of trials do not meet all pillars is a bad metric.

And, not all medications these days are pills or IV infusions - some medications and treatments, which are governed by the FDA, are more invasive and more complicated.

The consent process for clinical trials has a ton of guidance (ICH GCP), but the onus is on the clinical monitors and hospitals to make sure it’s done correctly. Many trials now generate supporting documentation in which hospital staff are required to describe the circumstances in which consent was acquired. If the documents are generated, then it’s auditable.

Things get a bit hairy when you look at trials in Alzheimer’s and other cognitive disorders, because the patient may not be coherent enough to withdraw from the trial. In those cases, a legal guardian is responsible for the decision.

Unfortunately, this was an issue before Trump and will continue to be one afterwards. Assuming there even is an afterwards…

The article brings up some great points, some of which that I, an industry insider, weren’t even aware of, especially the historical context surrounding the AIDS epidemic. I’ll jump into the thread to critique an issue within the article.

One of the four pillars recommended by the FDA (control groups) are great in theory but can lead to very real problems in practice, specifically within indications that have an unmet treatment need or are exceptionally rare conditions.

If you have a disease that is 99% fatal but has 0 standard of care treatment options, is it ethical to ask a participant to enroll in a clinical trial and potentially not receive the study treatment/be on placebo? Or, what if the trial involves an incredibly invasive procedure like brain surgery - is it ethical for people to do a placebo procedure? Food for thought - and an explanation for why so few trials meet all four criteria proposed by the FDA.

Happy to answer questions about the industry if anyone has them.

You’ll never believe how it effects sales tax (if you’re not buying from a second hand store).

Standard? Not really. But there’s a tutorial here: https://github.com/miykael/3dprintyourbrain

Happy to answer some questions if you have issues

Interesting question. It depends. I linked Ev Fedorenko’s Interesting Brain Project at MIT up above, they’re doing a deep dive into questions like those.

Broadly speaking, if you’re born with these anatomical anomalies, you’ll be more or less normal. The article mentions the person in question had an IQ of 70, so that’s lower than normal, but not intellectually impaired.

But acquired Brain damage almost always leads to impediments. Strokes and repeated concussions, physical injury, etc.

The brain is “plastic” when you’re young, we like to say. That is, it’s pliable and can mold into whatever shape it needs to in order to adapt to your environment. That plasticity disappears once you get older. It’s how kids can learn language effortlessly - when you’re born, you have the most neurons and synapses you’ll ever have in your life. You’ll keep the same neurons (unless you have a degenerative disorder or kill them with drugs), make new synapses as you learn, but broadly speaking as you grow up you prune synapses that aren’t helpful.

This is also why kids can undergo massive resection surgeries (or in the olden days, severing of the corpus callosum) and grow up more or less normal.

In the US getting an MRI for “no reason” can be very expensive. Probably wouldn’t have been covered by insurance.

Ev Fedorenko has done some of the best research in brain science, in my opinion. There’s no better rabbit hole than her research!

$$$

Eh, college is hard and so was his sport. Sure, it’s not an exhaustive battery of testing but I’m confident to say he’s a normal dude.

That’s the short of it - but we passed all brain data to a university affiliated neurologist for review. We also allowed participants to take a copy of their brain data if they wanted. I’ve got a CD of my own brain kicking around somewhere, and I even helped a few people 3D print their brains.

But, anything that I said about the participants brain opened me up to liability. What if I said their brain looked OK and there was a tumor? Or vice versa? The University felt I could be sued, so we were trained to not speak about their brain.

Well it’s not quite water, it’s cerebrospinal fluid and it plays a lot of important roles in waste clearance, immune protection, protection from concussion, and more.

Nope, not related to any disease I’ve ever seen. The best guess i have is fetal alcohol syndrome but it isn’t a perfect match. It’s just weird knowing he has a very odd shaped brain. And there’s a lot of unknowns surrounding it.

What if he sees another doctor and they mention it to him? Would he be upset I didn’t say anything? What if it is linked to some disease and I didn’t tell him, and he gets sick?

What if it’s hereditary and his kid has it, does it explain the motor delays? The premature birth? The problems they have with him sleeping?

Just a lot of unknowns.

We’ve actually seen a handful of them in the community. MIT has an “Interesting Brain Project” https://news.mit.edu/2023/studies-of-unusual-brains-reveal-insights-brain-organization-function-0221.

If you’re born that way, odds are you’ll be more or less normal. It’s amazing to see how resilient the human brain is.

In fact, one woman in China was born without a cerebellum. She wasn’t exactly normal per se, but she was alive and more or less healthy. Even though the cerebellum is smaller by volume it has about the same number of neurons as the cerebrum. So she just had half a brain. https://www.newscientist.com/article/mg22329861-900-woman-of-24-found-to-have-no-cerebellum-in-her-brain/

I ran a lot of MRIs for my PhD. I saw somewhere around 100-200 different brains. About 10% of them had abnormalities. Of all the technicians, scientists, and (non-clinical) doctors I spoke with, we all agreed this was a very high rate of discovery. All my friends graduated without seeing anything weird. My advisor liked to joke that I was cursed. Eventually I stopped inviting my friends to do my experiments because I didn’t want to deal with the risk of them having an abnormality - thanks to some combination of HIPAA and medical liability laws, I wasn’t allowed to say anything about it, even if asked point blank. I didn’t like that very much.

I made one exception, as a friend of mine came in for a study and I saw a golf ball sized cyst in his sinus. He had it surgically removed and he told me he stopped snoring the next day. It felt good to make a difference for him.

But, I saw one brain similar to the one documented here. It belongs to one of my close friends. It was harrowing. Entire left hemisphere was malformed, the ventricles were way too big and the cortex was way too thin. But the right side of his brain was underdeveloped, maybe the size of a tennis ball.

The weirdest part, he is 100% normal. In fact, he competed at a high level of college athletics. Normal Cognition, normal motor function, great sense of humor, and a very caring person. Now he has a great job, wife and kid, and we hang out often. But I can’t bring myself to say anything, and every time I see his son I wonder about his brain.

Pharmaceuticals in the US. Fairly early in my career, get paid just short of $100k/year. All it took was getting a doctorate and selling a little bit of my soul.

Sometimes I miss academic research. But at the end of the day I’m getting paid about 4x as much while working 1/2 the hours, by my estimate I’m 8x as happy now. Plus, there’s something to be said for working on projects that actually affect people’s lives instead of overstating the impacts of my research to compete for a dwindling pool of federal grants. Seeing the policy changes in the US this year, I’m very glad I left academia but I’m not convinced I’m 100% safe from changes made at the FDA.