Ah so a patent company who wanted to make a profit?
https://www.regulations.gov/docket/FDA-2023-E-2605
Interesting!
4,473 karma · joined January 1, 2022
https://www.regulations.gov/docket/FDA-2023-E-2605
Interesting!
This might be helpful to understand context too: https://youtu.be/ma0xH0EI7Us?si=Qhg5pz6-FgYC0j_o
I recommend you read it yourself and understand what it is saying. Not to make broad assumptions that “snake oil” will be allowed.
Here is a summary I wrote about this bill based on a condition I have that can benefit from it:
Quacks won’t be allowed in such regulated environments.
https://www.congress.gov/bill/118th-congress/senate-bill/190...
What you don’t do is make lofty promises to vulnerable patients.
If anything we live in a world where we need better provisions for these illnesses similar to https://www.congress.gov/bill/118th-congress/senate-bill/190...
Waiting for phased trials when you understand the research and hypothetical risks is torture. Especially when many drugs have proven safety profiles where the only harm is financial.
https://www.congress.gov/bill/118th-congress/senate-bill/190...
Give patients access and do the right science. Make sure it is safe and allow people the right to try.
For Long COVID, targeting G9a might also help alleviate lingering symptoms by potentially reversing the virus's long-term impacts on our bodies.
Based on a recent dissertation:
https://www.cell.com/cell-chemical-biology/abstract/S2451-94...
A novel G9a inhibitor has been identified that has been seen helpful for Alzheimer's as well:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10690335/
> Thus, in contrast to existing AD therapies that only slow one symptom (e.g., cognitive decline) targeting AD-activated G9a by the brain-penetrant drug MS1262 showed multifaceted effects that relieve all AD symptoms with minimum side effect.
https://www.science.org/content/article/giant-project-will-c...
I think these general statements are fine. I believe that AI will cure long COVID and ME/CFS soon.
I have already seen AI predict these illnesses with outstanding accuracy with no known biomarkers identified, drugs and molecules being found to neutralize it, and even new parts of the virus being identified to target.
I feel like this is the most exciting time to have one of these illnesses, cancer included. We may indeed find a cure for everything. Or at least everything we amply fund with billions of dollars.
We just entered the golden age of immune-cell therapies. I just can’t even imagine what we will do in the next ten years.
> I have a foreboding of an America in my children's or grandchildren's time -- when the United States is a service and information economy; when nearly all the manufacturing industries have slipped away to other countries; when awesome technological powers are in the hands of a very few, and no one representing the public interest can even grasp the issues; when the people have lost the ability to set their own agendas or knowledgeably question those in authority; when, clutching our crystals and nervously consulting our horoscopes, our critical faculties in decline, unable to distinguish between what feels good and what's true, we slide, almost without noticing, back into superstition and darkness...
That, but also how fake it is and has been for years now. I feel bad for all those influencers who fell off or can only do one thing because they created a "niche" and are known for doing that one thing.
Also how sad it is that it ruined many families because fame got in the way of values.
The opposite could probably be said, but as Carl Sagan warned, this medium has done more harm than helped us.
> The dumbing down of American is most evident in the slow decay of substantive content in the enormously influential media, the 30 second sound bites (now down to 10 seconds or less), lowest common denominator programming, credulous presentations on pseudoscience and superstition, but especially a kind of celebration of ignorance
The more interesting part? Immune cell-based treatments have really made their debut and things like monoclonal antibodies, msc, tregs, etc may just be the ticket.
There's a balance here. Some studies that take almost a decade can be of lower quality than some replicating studies that only took a year or two to conduct. It really depends on the researchers themselves, not the time.
Then comes the "grace under pressure" idea of the threat of a pandemic. This of course requires swift research to get to any resemblance of answers to things like life-saving treatments and protocols.
Of course early COVID-19 research was sloppy. That's the very human nature of it and looking back upon it is simply unfair to the mass uncertainty humanity shared.
> For example, researchers have known for decades that for studies evaluating the effectiveness of an intervention, a control group is needed to know whether any observed effects can be attributed to the intervention.
This point requires nuance. People's lives were at stake. That's why so many studies didn't require a control until later on in the pandemic. Interestingly there are adaptive models nowadays where if results are found fast enough, treatments can be offered to the placebo group instead of the outdated method we use today.
Regardless, we learned a lot in a short period of time. Hopefully we see significant change in the practice to prepare us for the next major humanity crisis. Things like decentralized clinical trials, adaptive clinical trial arms, outcome-based research, and patient-led involvement can sincerely change how we approach science for many decades to come.
At some companies, it is almost impossible to even raise concerns about a middle manager's performance. It should be much easier, especially if a group of people would rather work for one of their own than certain "bozos".
This summarizes this conundrum quite well:
> “Both things can be true,” Krumholz said in an interview. “They can save millions of lives, and there can be a small number of people who’ve been adversely affected.”
What we are learning about with regards to the immune system is that our bodies hate persistent antigens.
https://www.science.org/doi/full/10.1126/sciadv.adi9379
https://www.nature.com/articles/s41467-024-45107-3
https://www.nature.com/articles/s41590-023-01724-6
Additionally, there is a wonderful talk that covers many of these things here:
https://duke.mediasite.com/Mediasite/Play/ce2ecf77e1934b30aa...
https://www.humanimmunomeproject.org/
> For those we can’t cure, we can treat symptoms. We may not be able to remove the virus causing a cold from your system, but we can give you painkillers for your headache, tissues for your nose, or cough suppressant medicines. It’s not an ideal solution, but it is part of a realistic answer.
This is such a gamble. For example, I am one of the 1/10 of the population who has Long COVID from an early infection prior to vaccines thought no worse than a cold. There are also folks who got vaccinated and experience the same syndrome I do. I would never risk these odds to have to deal with over 3 years of constant debilitating pain when I was a previously healthy 29 year old now pushing 32. At this rate, I will likely see 5 full years of my life in a struggle before any treatment hits the shelves given there are very few things that can "treat the symptoms".
https://www.medrxiv.org/content/10.1101/2023.11.09.23298266v...
> At the start of this piece, I said I wasn’t fussed with the risk. Looking back at this later, I’m supposed to call this hubris. I still itch across most of my upper body. I’m alternating acetaminophen and ibuprofen. As I edited this piece weeks after the trial, I struggled with fatigue that made it difficult to work. Being released from the hospital only to develop worse symptoms is more than a little strange, but it did mean being taken care of by my partner and eating homemade meals at the worst moments, both of which I enjoyed. All in all, though, I don’t think it was hubris at all. The risks were reasonable, the pay made up for the itch, and I think the benefit to science doubly so.
Imagine if this were more debilitating like another illness (ME/CFS, Long COVID, Cancer, etc). Would you seriously risk years of your life for $5k? The only way I'd ever do this is as a sacrifice to the good of humanity. But we all know that our sacrifices aren't seen as anything further than a small paycheck in the grand scheme of pushing science forward. That needs to change and we need to devote more gratitude to people who are participating. Give them actual funds to sustain their symptoms with or find ways to dedicate their name towards the good of science often.
Find a human who can bypass robots.txt/limitations of ChatGPT and find less traveled sources given the internet fails to archive itself and important information can be wiped any minute? Isn't that just called good journalism?
There are so many studies that help answer all the questions you have on this topic. Peer reviewed and from reputable journals. LitCovid is very helpful here.
Pre-existing conditions
For 111 of 194 PCC patients, we also obtained their history of pre-existing neurological/psychiatric conditions.
31 of them (27.9%) had pre-existing neurological or psychiatric conditions.
16 of them had a history of depression (n=14) and/or anxiety (n=3).
One had a suspected addiction to alcohol.
One had a history of bulimia.
Nine of them had various neurological conditions, for example, migraine, tinnitus, trigeminal neuralgia, rotatory vertigo, amyloid angiopathy, fibromyalgia, polyneuropathy.
Unfortunately, we did not acquire the information about preexisting conditions from our controls but based on their self-reported no history of neurological and psychiatric diseases, suggesting that they would have no pre-existing conditions.
https://www.thelancet.com/journals/ebiom/article/PIIS2352-39...
> A significant proportion of male COVID-19 patients also display persistent low testosterone levels, reminiscent of absent or aberrant GnRH production, and SARS-CoV-2 has been shown to invade the brain. Taken together, these findings raise the possibility that in such patients, the GnRH system may be infected or dysfunctional, leading to the accelerated aging and cognitive deficits observed in patients with “long-COVID” or post-COVID syndrome. However, in what way and for how long GnRH neurons or their function may be affected in COVID-19 patients is still unknown.