Neuromancer49
@Neuromancer49@midwest.social
- Comment on F.D.A. to Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’ 2 weeks ago:
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.
- Comment on The FDA Is Approving Drugs Without Evidence They Work 3 weeks ago:
Good point, I’m assuming all monitors are as good as mine.
- Comment on The FDA Is Approving Drugs Without Evidence They Work 3 weeks ago:
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.
- Comment on The FDA Is Approving Drugs Without Evidence They Work 3 weeks ago:
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.
- Comment on The FDA Is Approving Drugs Without Evidence They Work 3 weeks ago:
Unfortunately, this was an issue before Trump and will continue to be one afterwards. Assuming there even is an afterwards…
- Comment on The FDA Is Approving Drugs Without Evidence They Work 3 weeks ago:
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.
- Comment on Does AI detect breast cancer better than doctors can? 4 months ago:
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. newyorker.com/…/the-pastry-ai-that-learned-to-fig…
- Comment on Biohybrid's Neural Implant Connects to the Brain With Living Neurons 5 months ago:
See Alk’s comment above, I touched on medical applications.
As for commercial uses, I see very few. These devices are so invasive, I doubt they could be approved for commercial use.
I think the future of Brain Computer Interfacing lies in Functional Near Infrared Spectroscopy (FNIRS). Basically, it uses the same infrared technology as a pulse oximeter to measure changes in blood flow in your brain. Since it uses light (instead of electricity or magnetism) to measure the brain, it’s resistant to basically all the noise endemic to EEG and MRI. It’s also 100% portable. But, the spatial resolution is pretty low.
HOWEVER, the signals have such high temporal resolution. With a strong enough machine learning algorithm, I wonder if someone could interpret the signal well enough for commercial applications. I saw this first-hand in my PhD - one of our lab techs wrote an algorithm that could read as little as 500ms of data and reasonably predict whether the participant was reading a grammatically simple or complex sentence.
It didn’t get published, sadly, due to lab politics. And, honestly, I don’t have 100% faith in the code he used. But I can’t help but wonder.
- Comment on Biohybrid's Neural Implant Connects to the Brain With Living Neurons 5 months ago:
A traditional electrode array needs to be as close to the neurons as possible to collect data. So, straight through the dura and pia mater, into the parenchyma where the cell axons and bodies are hanging out. Usually, they collect local data without getting any long distance information - which is a limiting factor to this technology.
The brain needs widespread areas to work in tandem to get most complicated tasks done. An electrode is great for measuring motor activity because those are pretty localized. But, something like memory and language? Not really possible.
There are electrocorticographic devices (ECoG) that places electrodes over a wide area and can rest on the pia mater, on the surface of the brain. Less invasive, but you still need a craniotomy to place the device. They also have less resolution.
- Comment on Biohybrid's Neural Implant Connects to the Brain With Living Neurons 5 months ago:
The most practical medical purpose I’ve seen is as a prosthetic implant for people with brain/spinal cord damage. Battelle in Ohio developed a very successful implant and has since received DARPA funding: battelle.org/…/battelle-led-team-wins-darpa-award…. I think that article over-sells the product a little bit.
The biggest obstacle to invasive brain-computer implants like this one is their longevity. Inevitably, any metal electrode implanted in the brain gets rejected by the immune system of the brain. It’s a well-studied process where a glial scar forms, neurons move away from the implant, and the overall signal of the device decreases. We need advances in biocompatibility before this really becomes revolutionary.
- Comment on Biohybrid's Neural Implant Connects to the Brain With Living Neurons 5 months ago:
Fantastic question, like Will_a said, I’ve never seen a device designed for input to the brain like this.
In this particular example, if someone were to compromise the device, even though it’s not able to “fry” their brain with direct electricity, they could overload the input neurons with a ton of stimulus. This would likely break the device because the input neurons would die, and it could possibly cause the user to have a seizure depending on how connected the input was to the users brain.
That does bring to mind devices like the one developed by Battelle, where the device reads brain activity and then outputs to a sleeve or cuff designed to stimulate muscles. The goal of the device is to act as a prosthesis for people with spinal cord injuries. I imagine that device was not connected to the internet in any way, but worst case scenario and a hacker compromises the device, they could cause someone’s muscle to sieze up.
- Comment on Biohybrid's Neural Implant Connects to the Brain With Living Neurons 5 months ago:
Agree, fascinating question. To be precise, they used genetically modified neurons (aka optogenetics) to test if the device can deliver a signal into the brain. Optogenetics incorporates neurons modified with light-sensitive channel proteins, so the neuron activates when a precise wavelength of light is “seen” by the special protein. One of the coolest methods in neuroscience, in my opinion.
“To see if the idea works in practice they installed the device in mice, using neurons genetically modified to react to light. Three weeks after implantation, they carried out a series of experiments where they trained the mice to respond whenever a light was shone on the device. The mice were able to detect when this happened, suggesting the light-sensitive neurons had merged with their native brain cells.”
- Comment on Biohybrid's Neural Implant Connects to the Brain With Living Neurons 5 months ago:
Oh neat, another brain implant startup. I published in this field. If anyone has questions, I’m happy to answer.