LC drug trials - we possibly won’t profit too early

[marcjf]

Not optimism, determination.
If any drug developed helps us, i intend to get it.

Bear in mind that new drug development takes years.

Have we been conditioned to think that drug development is supposed to take years?
We also need to remember that a dozen of vaccines have been rushed into the market in less than a year.

It seems that it only takes years because we are not being prioritized.

 

[Rufous McKinney]

It seems that it only takes years because we are not being prioritized.

the mRNA type of vaccines has been under development and study for maybe a decade- and lots of public funding of that work, as I understand it.

A specific virus showed up. They worked fast, had the genetics mapped in a few weeks...

employees quit going home at Pfizer... It seems this vaccine can stop it.

what exactly should be stopped in us?

you'd think if we could kill flat out eppstein barr in our bodies, some of us would recover, but we don't even really know that. Yet.

 

[Alvin2]

the mRNA type of vaccines has been under development and study for maybe a decade- and lots of public funding of that work, as I understand it.

A specific virus showed up. They worked fast, had the genetics mapped in a few weeks...

employees quit going home at Pfizer... It seems this vaccine can stop it.

what exactly should be stopped in us?

you'd think if we could kill flat out eppstein barr in our bodies, some of us would recover, but we don't even really know that. Yet.

Actually more than a decade, i had looked into it and research was happening since the early 90s iirc.

A vaccine has one active ingredient which is what is really being tested in clinical trials. Whether its mRNA or a dead virus or a viral vector. Its meant to give the immune system a blueprint to make antibodies for, which is much simpler then most drugs mechanism of action.

Non vaccine drugs on the other hand have a very different mechanism of action, they affect a receptor or cause some other biochemical change in the body. Often there are side effects that are completely unexpected if the behaviour of the target is not well understood. In vitro testing to animal testing to different species testing to ethical approvals to human clinical trials to multiple trials to participants that are not perfect population (healthy except for the one condition its testing tested for) and data analysis takes a great deal of time. And in many cases imperfect trial participants are never tested at all, people with multiple conditions, women who are pregnant and so forth.

As i recall there was a trial of a drug that caused deaths in humans a few years back (a bit before covid), it had passed all other trials but it was fatal to humans. Nobody had any idea because animals are not perfect analogues for humans. I forget which drug it was, if anyone remembers please post a link, i think it was done in Europe, the deaths of trial volunteers was completely unexpected, there was a (expected) public backlash.

 

[hapl808]

Probably this one?

https://en.wikipedia.org/wiki/Theralizumab

Vaccines are theoretically simple - but I think (as we are proof of) that we know less about immune function than we think we know. I don't think we've done enough systematic studies on vaccines to make sure they're not one of the many things that can trigger ME/CFS, for instance. Difficult to study for many reasons, as I've said before.

Stimulating the immune system is not the issue. Making sure it isn't over-stimulated (myocarditis), or thrown off balance (ME/CFS, CIRS), and so forth. I remember back oh so many months ago where they said there was no possibility of any adverse effects beyond anaphylaxis because that just wasn't how vaccines worked. Then they found the myocarditis issue.

To be clear, I am pro-vaccine as I am pro-medicine. But I feel doctors and the health establishment doesn't consider side effects carefully enough in 'abnormal' cases. We are the abnormal cases that are mostly ignored or purposefully cast aside. They tend to only look at healthy people, or people who have the one disorder they are testing. I think it was mentioned in another thread the NIH program to study 'unusual' cases found they weren't unusual at all.

 

[hapl808]

And looks like Theralizumab was a misunderstanding of the dose dependent reaction in humans versus animals. The drug was renamed TAB08 and is undergoing trials it looks like. The dosage they started with was 1/1000th of the initial 2006 trial that caused organ failure. They slowly ramped up from there (but stopping around 1/20th of the 2006 initial dose it seems).

(Not sure if you meant another drug, though. I don't think any of the volunteers died, but pretty much all of them experienced multiple organ failure which doesn't sound ideal.)

 

[Alvin2]

https://en.wikipedia.org/wiki/Theralizumab

(Not sure if you meant another drug, though. I don't think any of the volunteers died, but pretty much all of them experienced multiple organ failure which doesn't sound ideal.)

Thats not the one, i am thinking of one that happened a few years ago 2017-2018 maybe?
Buts this one is still a good case in point.

Stimulating the immune system is not the issue. Making sure it isn't over-stimulated (myocarditis), or thrown off balance (ME/CFS, CIRS), and so forth. I remember back oh so many months ago where they said there was no possibility of any adverse effects beyond anaphylaxis because that just wasn't how vaccines worked. Then they found the myocarditis issue.

In medicine nothing is absolute, anyone who says it is is lying by falsely claiming authority.
Personally i prefer not to take any medication that has not been on the market for 20 years to weed out problems that were missed. However at times you don't have any other choice.
In the end every drug is an experiment, whether its been on the market for a month or a century. Heck we don't even understand how Tylenol works.

I don't think we've done enough systematic studies on vaccines to make sure they're not one of the many things that can trigger ME/CFS, for instance.

Thats another kettle of fish as much of the medical establishment still does not even acknowledge ME/CFS exists or is not psychosomatic. If something doesn't exist or is psychological why would you need to test a side effect that causes it becasue its not an organic disease.

 

[Breagjam]

We can make plenty of noise in this case. If ME Action and every other organization is smart they will call as many media contacts as they can google and work the room until the drug companies back down from the mountains of negative PR. And it doubles as raising our profile. A bold move but it could be done.
It comes down to seizing the moment, creating an Overton Window if you will.

Also like vaccines they may be shamed in itself to only charge at cost.

This is a little off subject, but as for MEAction, I wish in general they would be more aggressive, or at least have the resources to be. It seems like from an advocacy point of view, we just get more of the same. If they would pursue some type of legal strategy or consider how they can help facilitate one to at least bring some publicity and wide scale awareness of the discriminatory practices of NIH and CDC - I think would bring huge strides. I realize this is complex though

 

[hapl808]

Long Hauler advocacy groups are having daily conversations with NIH and others on how the extensive funding should be distributed and how to remove bureaucratic hurdles. I haven't heard of any of this happening with ME/CFS, or even if the Long Hauler advocacy groups acknowledge the connection and concern (other than occasionally in a sympathetic way for chronic illness in general).

 

[Martin aka paused||M.E.]

Long Hauler advocacy groups are having daily conversations with NIH and others on how the extensive funding should be distributed and how to remove bureaucratic hurdles. I haven't heard of any of this happening with ME/CFS, or even if the Long Hauler advocacy groups acknowledge the connection and concern (other than occasionally in a sympathetic way for chronic illness in general).

We don't have a lobby. That's a big problem

 

[Rufous McKinney]

A vaccine has one active ingredient

But also include something that jolts the immune system to wake up...hence, EG: aluminum.