Very few things are proved definitively in science. You test a hypothesis with statistics, which always carries a margin of error. Usually, it’s 5% - the probability that your data randomly supports your hypothesis, even though there’s no true relationship.

Personally, I prefer when journalists coach their language to avoid overstating the truth.

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.

https://en.wikipedia.org/wiki/Immunotherapy?wprov=sfla1

Immunotherapy is crazy.

Prion diseases would be harder because things circulating in your blood don’t always enter your brain (thanks to your astrocytes, which help protect your neurons). But if you can get the right cells to produce the right protein, you can do a lot of amazing things.

Well, we don’t yet have evidence that it’s bad for our bodies, per se. That’s step one to getting things to change, IMO. So far we just have theories. Personally, I subscribe to the theory that microplastics are linked to changes in immune cell function/inflammation, which in turn leads to changes in the brain amd leads to some types of neurodegeneratove disorders like Alzheimer’s. Again, a theory, not any conclusive proof. It could be the case that microplastics aren’t causing damage.

But, with the technology we have now, I can imagine some solutions. Most promising, in my opinion, would be something akin to an mRNA vaccine. Introduce the mRNA to your body to produce a protein that targets plastic and leads to its removal from the body, almost like an antibody.

But with the NIH in the United States now targeting mRNA vaccine research for “critical review” as part of Trump’s agenda, the technology may not be long for this part of the world… even though it has revolutionized our ability to quickly, safely, and inexpensively produce vaccines against disease.

Scientist here. Microplastics in the body are too ingrained in our bodies for bloodletting to do much of anything. They’re even found in fetuses.

The good news (?) is we don’t know enough about microplastics to conclusively say they’re horrible for our health. The bad news is, I’d bet a lot of money that they are.

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.

Hey, the NHS in the UK sometimes does things, too!

Looks like the WHO also leads vaccine strategy meetings, according to the ECDC. https://www.ecdc.europa.eu/en/seasonal-influenza/prevention-and-control/vaccines/vaccination-strategies

So I think the odds that no vaccines are available in the US are low, but I don’t know if the same flu strains are targeted across the pond.

My favorite AI fact is from cancer research. The New Yorker has a great article about how an algorithm used to identify and price out pastries at a Japanese bakery found surprising success as a cancer detector. https://www.newyorker.com/tech/annals-of-technology/the-pastry-ai-that-learned-to-fight-cancer

I kept a few recipes from a subscription I was gifted. Honestly, replacing the missing ingredients has been more fun than cooking the boxed meals.

Well shit. That makes a lot of sense.

No no, they listen. How do you think the “Hey Google” feature works? It has to listen for the key phrase. Might as well just listen to everything else.

I spent some time with a friend and his mother and spoke in Spanish for about two hours while YouTube was playing music. I had Spanish ads for 2 weeks after that.

I’ve raged and seethed about Neuralink so many times. There are so many obstacles needed to be overcome for a true Brain Computer Interface to work. Unless the company has magically solved some of the hardest problems in bioengineering, they’re just sacrificing monkeys for sport.

The Code of Federal Regulations (CFR) includes the laws governing the Food and Drug Administration. These laws are written in the blood of the exploited and vulnerable, like the victims of the Tuskeege Syphillis Experiment. Many of these regulations are specifically written to keep pharmaceutical and food companies from cutting corners in product development, testing, and manufacturing.

It’s not a necessary disruption. It’s going to kill a lot of vulnerable people.

I saw a Copilot prompt in MS PowerPoint today - top left corner of EVERY SINGLE SLIDE - and I had a quiet fit in my cubicle. Welcome to hell.