Do you want to trust your health with products that have been tested to meet or exceed federal standards and have been manufactured in facilities that are inspected regularly? Or are you more comfortable with someone known by friends an associates as Toast who makes his special cancer cure in an old bathtub out of CBD oil and clorox and taco bell sauce packets (the actual packets, not the sauce)?
The market will create standards if the Feds don’t. They can get on it or be left behind, their choice. Every store and every chiropractor and any massage shop and who the hell knows who else here has a brand of this stuff now here. All it’ll take is one bad batch hurting someone and one lawsuit and the problem will solve itself.
I think people aught to have choices. With the advent of social media and very good support groups, groups of people can report about things that work for them. There is no reason these things shouldn't be a choice. If your career will not allow it than there are more things to consider. Many of these people have already sacrificed their chosen career to survive.
I’ve sure learned about that seeing the people with my disorder who are paralyzed from it. Whew. Life changes. And you’ll try anything after that.
I don't really see CBD as being any different than other vitamins and supplements. They are not regulated, either. CBD is not really a manufactured product like regulated pharmaceuticals. It is a natural product where the manufacturing involved is extracting it from the plant, and then inserting it into some type of delivery system.
Now, as to how its use applies to pilots and the FAA, that's another subject entirely.
That’s why pharma will actively fight it with lobbying instead of studying it. Can’t charge $38,000 a dose for it.
Will I try it while I’m grounded anyway? Not sure. Should folks who don’t have to worry about FAA or other Fed War On A Plant massive law enforcement money issues blocking it? Up to them. (I’m specifically talking about CBD not THC but frankly if you’re not working a critical or dangerous job, I don’t care if you’re using THC and can function but I’m concerned about you driving to work.)
I now have a rare disorder and get to see the dark side of Federal regulation of drugs. With one of my possibilities being a disorder that kills 40% of patients in the first five years of diagnosis and only 300 people a year diagnosed, as an engineer I see these problems clearly now:
Takes a minimum of 500 people and a long term study to obtain FDA approval for something on-label. You’re one of 300 a year who get this. You going to agree to come off of your off-label drug that appears to be keeping you out of relapse to “try” the new drug and take a risk that you die because you got the placebo? You know what, people do it, and they’re saints. That’s absolutely insane. But that’s the deal the government gives you if you want FDA Approval.
Now mix that with this second problem. Some crappy insurances refuse to approve any drug that is NOT FDA approved and is being used off-label.
Wait a minute... can’t have a drug that will keep you alive but nothing is FDA approved and nobody wants to die to find out if something can be.
The MOST common treatment for cousins to MS is rituiximab. Guess what isn’t FDA approved for those off-label uses? You guessed it. Every MS patient can get it, no problem at all. Every cousin to MS? Maybe your insurance will allow it, maybe they won’t, maybe they’ll make you wait and possibly die while they make a determination that your doc isn’t a moron to try it.
Guess what’s going off of patent and will be even cheaper than it already is? Rituximab.
Guess what isn’t? Nearly an identical drug from the same manufacturer that will have ten years of profit protection. Ocrevus.
Guess which one costs $38,000 an dose? Guess which one they FDA approved for more things even though rituximab has been used off-label for a decade?
Yeah. After learning all of this, I won’t ever lecture anybody with a rare disorder about trying ANYTHING out there ever again.
The FDA process for rare diseases and disorders without cures is absolutely and completely broken.
Oh forgot to mention. You know what else will happen? Docs wanting to use a particular drug will just LIE about the diagnosis. It’ll cause other problems maybe down the road for the patient, but if it gets the doc the drug they want? It’s going to happen.
For all these docs know — on SOME of these related disorders the patient DOES have the more common one that’s “on-label”, too. But they have to be free to use their brains and prescribe EXACTLY what they want to. So they’re going to write down “patient has this disorder” and go with it.
Do I trust the FDA process on simple stuff that isn’t rare and lots of data is available? Sure.
I trust the specialty docs a lot more on rare and exploratory issues when they’re still trying to figure it out.
Pushing the idea that FDA approval is some end all for things breaks when insurance companies suddenly think that’s true. Doesn’t work for rare diseases and disorders. Flat ass broken. Go see for yourself.
