Court: Off-Label Drug Marketing Is ‘Free Speech’
http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/36256
It is now official (unless the Supreme Court overturns it, which isn’t likely to happen), Big Pharma can now peddle any drug that made it through the FDA approval process for anything they feel like. Given the gullibility of the sheeple (isn’t that why the FDA was created in the first place? Man, we really are going back in time, just like the GOP wants!) I am quite sure that, as the article says:
“It’s a safe bet that health outcomes will decline from medication side effects, while spending on prescription drugs will continue to rise.”
This is the _exact opposite_ of what our nation needs to get control of the spiraling health costs. But hey, as long as the rich keep getting richer, who the heck cares if a few people die? _They_ should have educated themselves!
“… peddle any drug that made it through the FDA approval process for anything they feel like…”
I didn’t see that. I thought it said off-label marketing that was TRUTHFUL and NOT MISLEADING was allowed. I don’t have a problem with that. If a drug is found to salutary effects in an area not approved by the FDA, why shouldn’t that news get out?
Snake oil sales were false and misleading.
What is ‘misleading’? When a tiny study shows some positive results, but isn’t considered statistically significant (realize that you can continue running small studies _until_ you get these results!), is it ‘truthful’ to tout those results to promote drug sales? Given that quite a few of the large ‘legitimate’ (but paid for by the pharmaceutical companies) experiments yield results that are statistically dubious (at best), yet result in FDA approval, this ruling will open the flood gates. As the article suggests, no doubt Big Pharma will start to extensively advertise off-label uses of drugs on the flimsiest of pretenses. Doing good science is often not easy when the people are sincere, when they have an agenda good science is nearly impossible.
Read your post. You’re setting up post conditions to support your position. No one has previously mentioned tiny studies with insignificant or dubious results. No one is even talking about dubious FDA approval. We’re talking about FDA approved drugs that may have salubrious results in areas that haven’t been studied.
Your statement that big pharma may cheat is entirely believable (as well as expected). That does not negate the possibility that effective drugs may be useful in cases which have NOT been studied by the FDA but which may be well (or less well) known — situations that may have been noticed by practitioners and applied to the good of their patients.
What you are really saying, which runs contrary to your own beliefs (as expressed here) is that good effects should be prohibited because they open the door to crooks who will make a lot of money by being crooked. Screw the beneficiaries, if they’re in the minority, merely to stymie the profit takers.
I don’t like doctors. I don’t like lawyers. I don’t like politicians. Hell, I don’t even like some engineers. This does not prevent me from recognizing the fact that some very small percentage of these people actually do some good. One teeny-tiny amount of good outweighs lebenty-seben tons of evil. It may not win, but one has to give it the chance because any probability of a win, however small, is far superior to a loss. If such is not so we may as well unleash a few fusion devices whose radiation levels are deadly for some period exceeding a couple of generations.
Science, when viewed rationally, is everything. Science, when viewed irrationally, is nothing. Scientists must realize that they need to find a few practitioners who will forego the ivory towers and become evangelists. Barring that, the human race is doomed to either death or to a cycle of retrogression followed by progress followed by retrogression.
Half the population is doomed to be below average. It isn’t a death sentence, it’s a definition. There is no barrier to raising the intelligence that raises the average and there is no barrier to reducing the intelligence that lowers the average.
Ignorance is lamentable, but it is not stupidity. Ignorance is cured by teaching. There is no known cure for stupidity. Teaching should not be left in the hands of the ignorant who are otherwise unemployable, but that’s what we do. We don’t want them to be fucking up the world of marketing and economics, so we stick them off in a corner and give them the task of teaching our kids? Is that inimitably stupid, or what?
It seems I am not effective at getting my point across, perhaps by failing to provide suitable background. Yes, there are _some_ off-label applications that have a useful effect and that is going on today. The difference is the drug companies are not marketing directly these off-label uses. For the most part it is a doctor-to-doctor sort of thing, sometimes abetted by publications. The difference is the majority of the people involved know that the use is not what has been approved by the FDA, hence is EXPERIMENTAL and there have been no large-scale clinical trials to demonstrate efficacy. What I feel sure is going to change is that these experimental uses (where there has been no clinical trials to show that there is anything more than the placebo effect; I feel sure you have read my thoughts on that subject) are now going to be on TV and print advertising and people, because they foolishly think that anything seen on TV has somehow been vetted by our government, will think these uses have passed clinical trials and are thus approved by the FDA. The likely new reality is that where any doctors have chosen to prescribe a drug to their patients for any use, Big Pharma will then trumpet that use to the credulous population. How different is that from snake oil?
The traditional route for new (approved) uses of drugs has been an accumulation of anecdotal evidence from doctors experimenting on their patients that has convinced drug company to pony up for the clinical trials where the formal (controlled, double blind) studies were performed to find out if there was any efficacy beyond the placebo effect. Now the drug companies won’t have the slightest incentive to pay for these sorts of trials, why risk failure when they can just sell directly to the sheeple?
Regarding “No one has previously mentioned tiny studies with insignificant or dubious results. No one is even talking about dubious FDA approval.” This sort of stuff happens all the time and because the FDA is staffed by the revolving door (see my other post “An effect of the healthcare industrial complex”) we _already_ have poor oversight when it comes to the patient’s best interests. For years the NIH has been working to promote legislation forcing the drug companies to publish all data from all trials instead of cherry picking the successful trials for publications (to my knowledge such publication is still voluntary). It is with this background that I talk about the horrors of what is to come now that even the minimal leash that the FDA has been using will be cut altogether. Now all a drug company has to do is have the drug approved for any single use they can push through the approval process, then they can market it for anything else they desire.
Overturning this decision (like that is going to happen) won’t have the slightest negative effect on the experimental off-label uses you talked about. Doctors can prescribe any approved drug for any application already. The difference now is that the drug companies can turn their billion dollar marketing and advertising campaigns to these off-label uses.
So. Given your presumed inability to stop robber barons from preying on the gullible in any area, what would you do about pharmaceuticals and their distribution? In terms of improving the lot of the suffering, I mean?
Advances (of any sort) are rarely, if ever, engendered by the profit-takers. They come from mavericks. I would guess that 99.99% of the mavericks are hustlers and snake-oil salesmen. The other 0.01% are responsible for the advances. I suspect that outlawing all mavericks on the grounds that they are detrimental to the common welfare is a losing proposition.
If the human race succeeds in destroying itself it will be because they have gained the power to overturn Darwinian principles for a period of time so short that those principles have no chance to work. Selfishness is the root of all evil, but selfishness is also the root of all survival. Altruism is a luxury that can only be afforded when all else is going well.
When people no longer trust science and technology because the snake oil salesmen have run amok (since only 15% of our population believe in evolution, I would say we are really getting close!) then the 0.01% you mention get completely lost in the noise, possibly even burned as witches. Rather than advancing, at that point we would be regressing. I see the upholding of this legal precedent as the end of any forward progress and the beginning of increasingly large steps backwards.