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(LA Times)   It is now legal to sell hand sanitizer by telling people it cures cancer   (latimes.com) divider line 13
    More: Spiffy, hand sanitizer, antipsychotics, 1st amendment, panels, free speech, cancers, sleep disorders, U.S. Supreme Court  
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5835 clicks; posted to Main » on 07 Dec 2012 at 9:44 PM (1 year ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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Archived thread
2012-12-07 09:46:51 PM
2 votes:
This ruling was bought and paid for by Pfizer. Guarantee it.
2012-12-08 05:39:05 PM
1 votes:

LordOfThePings: For responding to sarcasm sincerely?


Not sure if you care, but...

BronyMedic and I have been in a multitude of threads over the years combating the anti-science folk. It's kind of nice to receive recognition from someone I respect for the posts I've made on Fark. Because I'm not a particularly snarky person, I tend to be ignored around these parts, but I figure that people like factual information, so I post mostly for the lurkers. Some of the threads I've saved because I like the comments and want to keep them for future use (which have come in handy from time to time). This thread (specifically the linked post) was one I was particularly proud of (ignore the typos).
2012-12-08 04:43:20 AM
1 votes:

Zugswang: If you have a drug already on the market and you find another indication for that drug, filing a supplemental new drug application is not such an overwhelming onus, in terms of time or economics, that you wouldn't just wait for its approval before telling health care professionals and customers (and I say customers, because that's the relationship pharmaceutical companies have with the people we refer to as "patients") that drug x is indicated for use y. The data is there, it just has to be assembled and sent. And before anyone jumps in about how arduous the drug approval process is in this country (which is true, and for good reason), the process by which an already available drug gets approved for additional uses is comparatively painless.


While I agree with you in general, I think you've missed one big complication: about 90% of pediatric drugs are used off-label because they have never been tested in children. To get approved for use in a new population (children) I think they'd have to do complete safety tests, not just simple efficacy tests.
2012-12-08 03:12:35 AM
1 votes:

firefly212: BronyMedic: modelcitizen: This is done every day in every state by drug reps. I've been to the conferences (aka free fancy dinner to listen to their pitch). It's the doctors call and their responsibility to make the correct one. If they think it might have substantial off label use, they should do the research and make their decision accordingly. Sadly, this happens very rarely in reality.

I didn't think that drug reps were allowed by federal law to push medicines for off-label uses they were not FDA approved for. I know in our system, no one is allowed to get any swag or free meals when a drug rep or medical rep comes to give a class or talk, and it's a terminatable offense for doing so.

Which sucks. Drug reps always had the best pens and swag.

The swag is gone, but they are still allowed to push for off label uses. : ( It is a sad thing that I learned a little too late in the game.

With regard to mr. ephedra is safe because I don't believe the death statistics related to it, but PPIs are made of evil and death because people can still catch pneumonia while on it, he's the reason I've been cranky the last few weeks. That is to say him and people like him. In a growing number of threads, there's this wacky belief that "my ignorance is equal in validity to your science" from young earthers to tectonic plate denyers to the Christ Scientist now at the head of the House Committee for science, to anti-vaxxers to when people were calling Rachel Maddow unqualified to speak to President Obama on the topic of how to present/merchandise his tax package (she is a Rhodes Scholar with a PhD in Politics from Oxford)... there's this weird belief out there that seems more and more pervasive every day that people can simply make shiat up, and that's as good as the people on the other side having an actual, oberservable-reality-based argument. It frustrates me beyond belief, I haven't the foggiest clue how to engage people who have consciously chosen to disengage from the reality ...


Well, let's try our best to have a substantive discussion.

I read this article, and the sad thing is, this contortion of the first amendment isn't a unique argument. If you recall, this is an almost carbon copy of the argument that was put forth by credit ratings agencies when they claimed that they were not liable for the now definitively wrong credit ratings they assigned to different groups and organizations, because it was their "independent opinion". Never mind the fact that their "opinion" was widely recognized and advertised by these agencies as being based off of rigorous expert analysis of a company assessing its economic health and creditworthiness. (There must be some hidden bunker where business law attorneys go to torture the English language until it says what they want it to, like some kind of linguistic S-21.)

But the difference is, the claims to drug indications are about as close as an absolute fact as you can realistically get. Claims for which we can provide direct, verifiable, repeatable evidence. It's why I hold out hope that this appeals court ruling will be overturned. If you have a drug already on the market and you find another indication for that drug, filing a supplemental new drug application is not such an overwhelming onus, in terms of time or economics, that you wouldn't just wait for its approval before telling health care professionals and customers (and I say customers, because that's the relationship pharmaceutical companies have with the people we refer to as "patients") that drug x is indicated for use y. The data is there, it just has to be assembled and sent. And before anyone jumps in about how arduous the drug approval process is in this country (which is true, and for good reason), the process by which an already available drug gets approved for additional uses is comparatively painless. Hell, you have to file a supplemental NDA if you change how the drug gets made. It's incredibly disappointing to think that short-sighted people who have no appreciation of history are attempting to reverse 80+ years of legal framework in the interests of making a short-term profit at the expense of everyone else, and it's happening in the two most important spheres of citizens' lives: medicine and finance.
2012-12-08 12:42:11 AM
1 votes:
BronyMedic, you beat me to it.

Also, am I the only person in here who was grinding their teeth when when they extrapolated that "33,000" number from different sets of statistical analyses and carelessly tried to pass if off as a legitimate estimate?
2012-12-07 11:22:33 PM
1 votes:

BoxOfBees: 1. Information is widely available. The Internet. Libraries. Books. Magazines. Informative T-shirts.
2. Physicians can help people come to decisions about medications. Sometimes.
3. Not everyone has a physician or pharmacist, so some people, in order to save money, might just take x random drug and hope it cures them. This sounds like a travesty, but considering the number of people self-medicating with various opioids and some other drugs, the pendulum won't swing very far in terms of real consequences.


Number three is terrifying. You do realize that there are a LOT of drugs in common use that if not closely monitored, can kill you or quickly become toxic, right? In addition, one that comes to mind immediately is antibiotics. We have a huge problem right now because people stockpile antibiotics for one condition, and take them for another weeks or months afterword. Not only do they promote antibiotic resistance for the conditions they don't finish their course because "they feel better", they take drugs which can cause real harm, or promote antibiotic resistance for other conditions that they are ineffective for, or they take them for viral illnesses.

There's a reason why Paramedics (In the last 5 years.), RNs, Nurse Practicioners and PAs, and MD/DOs go to school to learn how to use the drugs they use like that.

BoxOfBees: so is the recent fungal meningitis outbreak. Some companies will engage in unsafe practices even when strict regulations are (supposedly) enforced.


The Fungal Meningitis outbreak is actually a case where lax regulation standards contributed to it. If you have a few hours, set down and read the issues and preceding timeline of events that lead up to it, namely the issues with pseudo-manufacturing compounding pharmacies. They exploit legal loopholes to do what they do, when the laws that allow them to operate never intended for them to be manufacturing the medicines they were using.
2012-12-07 11:21:36 PM
1 votes:

BoxOfBees: BronyMedic: Amos Quito: On the contrary, the FDA is a safeguard of oligarchic monopoly.

You don't study history much, do you?

Pure food and Drug act of 1906, i.e. what the world was BEFORE pharmaceuticals were regulated.
What happens when the Government has no teeth to enforce prescription drug standards, i.e. the Elixir of Sulfonamide disaster.
What happens when AltMed Shills get friends in congress.

I agree that it's good to help people get medicine that will supposedly help them, but consider:

1. Information is widely available. The Internet. Libraries. Books. Magazines. Informative T-shirts.
2. Physicians can help people come to decisions about medications. Sometimes.
3. Not everyone has a physician or pharmacist, so some people, in order to save money, might just take x random drug and hope it cures them. This sounds like a travesty, but considering the number of people self-medicating with various opioids and some other drugs, the pendulum won't swing very far in terms of real consequences.

the Elixir of Sulfonamide case is interesting

so is the recent fungal meningitis outbreak. Some companies will engage in unsafe practices even when strict regulations are (supposedly) enforced.

I generally advocate for across-the-board legalization of all drugs. Keeping people in the dark and nanny-stating them out of harm's way is not a fool-proof system. Knowledge is power. I don't take any drugs, and I have rarely taken even prescription medication in the past, so I really have nothing to gain except that I want to encourage my fellow citizens to be responsible and free.


I I agree that knowledge is power, and we should empower consumers to know about the medicines they purchase. The problems comes when there is so much information that is untrue that it is difficult for a lay person to distinguish between what is factual and helpful and what is not.

When it comes to meds, the Internet can be a horrible place to get info.

/got my first tablet. Typing on these things accurately can be difficult.
2012-12-07 11:21:09 PM
1 votes:

Amos Quito: BronyMedic: Amos Quito: On the contrary, the FDA is a safeguard of oligarchic monopoly.

You don't study history much, do you?

Pure food and Drug act of 1906, i.e. what the world was BEFORE pharmaceuticals were regulated.
What happens when the Government has no teeth to enforce prescription drug standards, i.e. the Elixir of Sulfonamide disaster.


I'll see your Sulfonamide, and raise you a Thalidomide (or any one of DOZENS of FDA approved "safe and effective" products that have killed, maimed, and CONTINUE to kill and maim Americans in their tens (hundreds?) of thousands annually.

Show me an "herbal supplement" that compares to the hell raised by NSAIDS or even PPI's, and I'll show you a product that was yanked from the market.


You idiot, you need to read up on thalidomide and FDA, AND WHY THERE WERENT ANY THALIDOMIDE PRESCRIPTIONS to pregnant women in U. S.

This ruling may not protect pharma companies from civil judgments for off label promotions, and SCOTUS may get involved.

Free speech should be jealously guarded and patients sgould be protected.
2012-12-07 11:20:48 PM
1 votes:

Amos Quito: BronyMedic: Amos Quito: On the contrary, the FDA is a safeguard of oligarchic monopoly.

You don't study history much, do you?

Pure food and Drug act of 1906, i.e. what the world was BEFORE pharmaceuticals were regulated.
What happens when the Government has no teeth to enforce prescription drug standards, i.e. the Elixir of Sulfonamide disaster.


I'll see your Sulfonamide, and raise you a Thalidomide (or any one of DOZENS of FDA approved "safe and effective" products that have killed, maimed, and CONTINUE to kill and maim Americans in their tens (hundreds?) of thousands annually.

Show me an "herbal supplement" that compares to the hell raised by NSAIDS or even PPI's, and I'll show you a product that was yanked from the market.


Ya, Ephedra... you're arguing which of the deadly dumbass things is deadlier. It's like you two are having a hemlock v. cyanide argument. You're both right, in that there are clearly bad things on the other side... but also both in quite possibly the dumbest pissing war I've witnessed on fark, and that's really saying something.
2012-12-07 10:52:08 PM
1 votes:
2012-12-07 10:25:27 PM
1 votes:
Sorry to interrupt the circle jerk of ignorance going on here, but it doesn't seem like any of you understand what the ruling means.

It doesn't mean selling medications that don't work or are dangerous is protected by free speech.

Many drugs can be used for multiple conditions. The FDA wants the drug companies to do years and years of tests for every condition a drug is supposed to be marketed for. Now once a drug has been approved for any reason, a Dr can prescribe it 'off label' for whatever the Dr wants. The drug still went through years and years of tests showing its level safety, just not a new process showing how effective it is for every specific condition.

It is up to you and your Dr to decide if he/she wants to have you try an off label medication, and usually there's a good reason. All this ruling says is that the drug rep is aloud to talk about the off label uses.

It's ultimately up to your Dr to prescribe it, and your right to find a be Dr
2012-12-07 10:17:26 PM
1 votes:

AliceBToklasLives: Meh, caveat emptor.

/why do we have the FDA anyway? It's restraint of trade.
//I don't need nanny government to run drug trials I can damn well perform myself.


Because neither you nor I (a trained toxicologist with a higher education) nor anyone else is able to tell exactly what is in that medicinal bottle (or pill or whatever) you're being sold without equipment that cost hundreds of thousand of dollars to purchase and years of training to operate and analyze.
2012-12-07 10:03:29 PM
1 votes:
Spiffy? That's farking scary!
 
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