Here's how [off-label drug use] works: once a drug gets approved for any condition, whether it's a skin disorder, a mental disorder, or a cardiovascular problem, it can then be legally prescribed by doctors for everything. In other words, a drug approved for heart disease can be prescribed for diabetes, even though there's absolutely no testing done whatsoever with the drug on diabetes patients. It sounds surprising or even downright astonishing to those who don't know how the medical industry really operates, but it's absolutely true, and it demonstrates why the so-called "scientific evidence" behind conventional medicine is nonsense.
It isn't science; it's just marketing. What science is there that would allow a drug tested on one condition to be used for everything?
...
It also makes a mockery of conventional medicine's criticism of natural therapy. Such critics claim natural therapies aren't safe because they've never been proven to treat certain conditions, and yet their own favorite drugs are routinely used to treat untested, unapproved health conditions. It's classic doublespeak from drug promoters, and it's indicative of the kind of double standard routinely practiced in organized medicine today.
Yes, the criticism is ironic indeed when you consider "off-label" use!
I first heard about off-label use several years ago. Pat was doing due dilligence on a potential investment into a medical device company. The founder of the company had used the device in his practice for a wide variety of uses, but it was unapproved for any claims. So he was instructed to get it approved for something very niche, and then let practioners use it for whatever they wanted. (Not sure what ever happened to that company/technology since Pat did not invest...)
But I've never quite thought of the fallacy of off-label use before today. What does the multi- multi-million approval hurdle created by FDA really mean? When you cut down to it, it means doctors have free reign to do whatever they want with your new chemical. If they find it works well based on empirical results, then word gets around and that's what the drug ends up being used for.
Mike goes on to rail about rigging clinical trials, etc. I've said this before, but I believe the system of drug approval and need for patents is what's really broken.
In related news, RandomJohn points to a very interesting report in a recent JAMA article that correlates positive outcomes based on funding sources, for-profit vs. non-profit. I thought it would be just a "shock headline", but the numbers are pretty startling.
(Posted by Patrick Sullivan Jr.)
From Newstarget, Off-label drug use and the sham of FDA-approved drug safety:
Yes, the criticism is ironic indeed when you consider "off-label" use!
I first heard about off-label use several years ago. Pat was doing due dilligence on a potential investment into a medical device company. The founder of the company had used the device in his practice for a wide variety of uses, but it was unapproved for any claims. So he was instructed to get it approved for something very niche, and then let practioners use it for whatever they wanted. (Not sure what ever happened to that company/technology since Pat did not invest...)
But I've never quite thought of the fallacy of off-label use before today. What does the multi- multi-million approval hurdle created by FDA really mean? When you cut down to it, it means doctors have free reign to do whatever they want with your new chemical. If they find it works well based on empirical results, then word gets around and that's what the drug ends up being used for.
Mike goes on to rail about rigging clinical trials, etc. I've said this before, but I believe the system of drug approval and need for patents is what's really broken.
In related news, RandomJohn points to a very interesting report in a recent JAMA article that correlates positive outcomes based on funding sources, for-profit vs. non-profit. I thought it would be just a "shock headline", but the numbers are pretty startling.