"Edaravone showed efficacy in a small subset of people with ALS who met criteria identified in post-hoc analysis of a previous phase 3 study, showing a significantly smaller decline of ALSFRS-R score compared with placebo. There is no indication that edaravone might be effective in a wider population of patients with ALS who do not meet the criteria"
Another paper is quite skeptical:
"Edaravone: a new treatment for ALS on the horizon? Orla Hardiman, , Leonard H van den Berg"
Overall, I'm always skeptical about treatments that focuses on "reducing oxidative damage"...because if you think about it, it doesn't really focus specifically on the disease itself. Oxidative damage happens to everyone daily, just by breathing air.
There's a bit of viewgraph engineering too, because the treatment group declined by 5-ish points, and the control group by 7 ish points out of a 48 point scale, they say "33% improvement"....
That being said, I suppose because it does something more than riluzole and doesn't kill anyone more than a typical chemo therapy, the company managed to get the FDA to Ok it...TBH, I probably should be more familiar w/ the criteria with which the FDA OKs or doesn't OK something
A whole new class of drugs is reaching these prices. "The insurance" doesn't really pay; those xx% increases every year in premiums do.
Really? If it works it could get approval.
http://www.pharmaceutical-journal.com/news-and-analysis/news...
£340,000 per year, but for a tiny number of people.
Apparently they don't even want the federal government having standards for acceptable insurance plans (but they want a federal law saying that the standards set by any state can be used to market plans in all states).
$146k/year for being able to live a better life, or maybe at all. right up there with cancer treatments according to my ethical standards.
Stuff like this doesn't scale in the way we are used to. There are only 30,000 ALS patients in the US, and this drug only benefits a subset of those people. And it costs tens if not hundreds of millions of dollars to develop. How exactly should you price it?
Now you can say the government should pay for it. And I agree that as a general matter the government should pay for healthcare. But that's not really a workable solution here either. At that point you've got to ask the difficult but necessary question: should the government be investing that much money to help maybe a few thousand people? Imagine how many poor kids whose lives you could change with that money instead.
The stuff is called edaravone. Radicava is the name that was made up by some marketing intern.
Giving placebo to ALS patients? How is that allowed ? They should be able to tell already what is the course of a typical ALS patient without using such methods. For cancer drugs there are no placebo used since there is extensive survival data available to prove whether or not a drug actually makes any difference.
>For cancer drugs there are no placebo used since there is extensive survival data available to prove whether or not a drug actually makes any difference.
Source, please?
http://www.cancer.net/navigating-cancer-care/how-cancer-trea...
"In past years, it was generally not necessary or possible to use placebos in cancer clinical trials."
