Fucking FDA won’t let me spit in the OP’s medication. I tell you, that body has no sense of justice. Fucking cGMPs…
I’ll bet you $5 you won’t have sex with me…
It’d almost be funny if it wasn’t reality.
Absolutely. This is a really interesting debate. I use the Vioxx example all the time. My mom quit using it right away when she decided it wasn’t worth it, but that was her choice. (Yes, I know, it’s not available, but she threw away what she had left at the time.) Shouldn’t she have the right, though, if her arthritis gets very bad, to go back on it, fully knowing the risks? Shouldn’t we be allowed to have some choice in our medications, as long as the risks are represented as accurately as possible?
Long-term data only comes from long-term use, and can you imagine the shitstorm if the FDA decided that we would have 25 years of “gathering data” on a small group before the actual public is allowed access to a life-saving or life-altering drug? It’s funny how some of the people who support the legalization of marijuana and other currently illegal substances can get all up in arms about the FDA allowing people to be prescribed drugs that have risks coming along with the rewards. “We should be able to choose what to do with our bodies! But only when it’s for recreation, not for medicine–then the FDA should protect us from ourselves!”
You know, I’m pretty hard pressed to think of any medical treatment that doesn’t have any side effects, any risks, any long-term effect, or any downside of any kind.
Sleep. And… drinking lots of fluids.
You can make yourself sick if you drink too much water. (See water intoxication.)
And I get headaches if I sleep too much. (Not that that’s happened since I had the last baby, of course!)
I had a teacher once who put it like this: “There are no “side effects”. There are simply “effects”. The ones we like, we call “treatment”, the rest we call “adverse reactions”.”
Any possible answer that I could give to that remark would get me in deep sh^t with every single woman on the SDMB.
Just shut up and commence with the free foot rubs. That’s your only chance for survival.
Trust me.
It’s an interesting issue. There is currently a very promising vaccine for prostate cancer that the FDA put the kibosh on a few months ago (I won’t go into the company or drug, so that no one accuses me of pumping, but interested parties could certainly find it. But I don’t work for them!). Everyone agreed that the safety data was sound, almost everyone agreed that the vaccine was effective. It extended life by several months, which with androgen insensitive prostate cancer would be better than any other treatment.
The problem? Extending life was the secondary endpoint of their clinical trials. The primary endpoint was tumor size, which while effective with the vaccine, did not quite meet statistics. And they only discovered that it extended life in a post hoc analysis. They did not say ahead of time that they were going to run these statistics.
There is currently something of a public outcry among cancer advocates to make the FDA make the drug available, at least as an emergency option for physicians.
If people accepted that drugs have side effects, and that they might be one of the few unlucky ones, I daresay we would have a lot more effective drugs on the market. Companies have to be extremely cautious, to the point of playing it too safe, in my opinion. Anything that shows any semblance of adverse effects, regardless of efficacy, is going to get scrapped in Phase I. If anything the FDA should be faulted for going too far toward safety.
When I pop a pill, I accept that there is the possibility of adverse effects. I make a judgment if it is worth it.
A new submission will need to be made, this time with the secondary endpoint as the indication. The problem is that the pharma submitted for a tumor-reduction indication, and they didn’t meet the stated goal. The FDA only measures the science against the stated goal - did you make it, or didn’t you? They didn’t. A second submission using the original data, with a restated indication should be possible, either immediately, or with relatively few additional trials. This is NOT such a theraputic advance that the FDA would be justified in modifying or excepting its rules. That is only reserved for significant theraputic advances. Making exceptions for non-significant advances merely encourages and sets precidents for more exceptions, many of which will not be justified, and which exception requestss will clog up the approvals process. The FDA is notoriously undermanned and underfunded - They don’t have the resources for unjustified exceptions.
I do tend to get leg twitches every so often. I’ve found that a little Ben Gay behind the knees helps.
I remember when I was in the hospital back in February, and during the EEG, I could NOT keep still. My legs kept kicking out, and I could NOT stop them. The tech tried distracting me, asking me what was up at the science center, but I couldn’t stop squirming.
Still, I don’t think I have RLS, at least not full blast. It’s pretty rare for me, but it still sucks. I can’t imagine having to deal with it every night.
Let me guess. You’re one of those dipshits who think mental illness is simply a result of a weakness and attention whoring.
Fucking shithole.
You misunderstand. Survival WAS a stated goal as a secondary endpoint. There is plenty of precedent for FDA approval of drugs that meet the secondary endpoint, but miss the primary endpoint. Particularly when the secondary endpoint is survival, which is more often the primary endpoint in the past few years.
The term “indication” is much different from endpoint, and has nothing to do with survival or tumor burden. That refers to the type of cancer, in this case androgen insensitive prostate cancer, which was not in question here.
What did the label request state? In the end, it’s all in the label. If they didn’t ask for that in the label, or if they asked too much, then see above.
Label issues are separate from efficacy issues. If a drug is deemed effective, the FDA will work with the company on the label, not nix it.
To prove efficacy in a phase III, you have to show that the drug shrinks tumors, or even better causes patients to live longer. Unfortunately, in the case I mentioned, they called shrinking tumors their primary goal, because it is usually an easier one to meet. But, survival, is the gold standard. They were surprised that they met survival, but didn’t quite meet tumor size (at least statistically).
Label issues only come into play if they wanted to expand to another indication, such as another kind of cancer. That wasn’t an issue here.
I was using this as an example of a drug that is, not beyond a reasonable doubt, but in strong likelihood an effective therapeutic. And doctors do not have the option of providing it.
But to be fair, the FDA hasn’t killed it either. My understanding was that they had issued an “approval letter” indicating that with appropriate additional clinical data that supported either tumor-size or survival endpoints the drug would probably be approved.
I’m travelling right now and can’t access the journals; have they published the clinical trials related to Provenge’s phase III yet?
…doctors?
Well, it’s killed for at least a year, and probably more. If the company can’t afford to stay in business that long, they’ll either have to partner or go under. Being that they have nothing else on the market, it’s a real concern.
There’s something of an upswell among prostate cancer patients who are likely to die in the interim to get it on a compassionate basis in the meantime. But so far there is no indication that will happen.
All of the Provenge (as long as we’re now naming names!) data is published.
Right.this goes back to what I said - They’ll have to support the alternate claim with data, or an alternate submission. Not approved for a year is not dead, nor even denied. Irbitux, for instance, was delayed, but it’s out there, and Imclone stock is right back where it came from. Partnering with another Pharma who actually knows how to submit to the Agency is an old, and proven, survival tactic.
Every war has one last casualty. Sucks to be that last guy down, but someone will be. Anyway, this isn’t going to save their lives, merely extend them. Which is good, but not a substantial thereputic advance. Compassionate use is a good try, but don’t bank on it.