Commercial speech is not exactly the same as personal expression, I expect a SCOTUS smackdown in the coming months.

 

Ah the good old days....

All the time I was on a drug (Neurontin) which was not approved for use as an MS drug, but was recommended as such pretty widely, was time my nervous system was getting shot to shiat because instead of taking drugs that had been tested for good efficacy, I was taking the advice of my doctor, who was taking the advice of a drug rep. =/ Fark those lying sons of biatches with rusty spoons... when you're poor and scratching together a third of your pay to afford drugs, mistakes like these are bad... but when they cause you to miss time when irreversible damage is needlessly done because you're on the wrong drug, it totally blows donkey balls.

Seems pretty strong evidence that the court was purchased... not exactly a surprise, but it sucks when they don't even try to hide it anymore... I fully expect at some point in the near future, the "judge" will request his payments from the representing counsel and whoever provides the highest check will get the winning judgement.

firefly212: All the time I was on a drug (Neurontin) which was not approved for use as an MS drug, but was recommended as such pretty widely, was time my nervous system was getting shot to shiat because instead of taking drugs that had been tested for good efficacy, I was taking the advice of my doctor, who was taking the advice of a drug rep. =/ Fark those lying sons of biatches with rusty spoons... when you're poor and scratching together a third of your pay to afford drugs, mistakes like these are bad... but when they cause you to miss time when irreversible damage is needlessly done because you're on the wrong drug, it totally blows donkey balls.

"Goorrram balls."

Whoo-Hoo! Time to break out the piss and ink and warm up the vats! Phil's Miracle Hair Tonic is back in business!

tricycleracer: fuk yea free makret

Is that anything like a Meerkat?

"The government clearly prosecuted Caronia for his words - for his speech," the majority wrote in the 2-to-1 decision. It concluded that "the government cannot prosecute pharmaceutical manufacturers and their representatives" under the Food, Drug and Cosmetic Act for speech promoting off-label drug uses.

"Off-label" usage is not the same thing as making up uses for a drug out of whole cloth and claiming your snake oil will cure brain tumors and retardation. I've been using off-label meds for years, since the process for approving psychotropic medications is very slow--as it should be. I certainly wouldn't want pharmaceutical companies to ban off-label usage completely; but I don't want to see their reps allowed to run around claiming whatever they want to, either.

It sounds like either this was a paid-for decision...or, just as likely, some judges didn't bother to understand what "off-label" really meant before they ruled. Either way, it better get overturned.

My father is taking some drug for back pain, but its only approved use is for something else. The company that made it marketed it for a laundry list of uses, and got sued for 8 figures.over the practice.

However, it is still prescribed all the time for those uses so the company easily recouped the money paid out.

/I thought I was contributing originally, but I think that qualifies for True Story Bro instead.

super_grass: Commercial speech is not exactly the same as personal expression, I expect a SCOTUS smackdown in the coming months.

Yup. Farking with meds can create (in the light of the recent meningitis scare) panic in the public, distrust in their physicians and is one of the worst ideas this century. This is the free-speech equivalent of yelling fire in a crowded theater.

Spiffy? That's farking scary!

Well, perhaps it can.Just like Fosters is Australian for beer, because texas and georgia are clearly down under

HindiDiscoMonster: tricycleracer: fuk yea free makret

Is that anything like a Meerkat?

Related. Different genus.

Alt-med peddlers are likely celebrating the decision.

Nowhere in the article does it say where this cancer-curing hand sanitizer may be purchased. It sounds convenient to keep in the glove box, in case I ever get cancer on the road, or just want to clean my hands and yet remain cancer free.

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.

Gyrfalcon: "The government clearly prosecuted Caronia for his words - for his speech," the majority wrote in the 2-to-1 decision. It concluded that "the government cannot prosecute pharmaceutical manufacturers and their representatives" under the Food, Drug and Cosmetic Act for speech promoting off-label drug uses.

"Off-label" usage is not the same thing as making up uses for a drug out of whole cloth and claiming your snake oil will cure brain tumors and retardation. I've been using off-label meds for years, since the process for approving psychotropic medications is very slow--as it should be. I certainly wouldn't want pharmaceutical companies to ban off-label usage completely; but I don't want to see their reps allowed to run around claiming whatever they want to, either.

It sounds like either this was a paid-for decision...or, just as likely, some judges didn't bother to understand what "off-label" really meant before they ruled. Either way, it better get overturned.

But "off-label" literally means "indications not validated by the FDA" - not "clinically proven indications not validated by the FDA". And there was no such clause attached to this ruling.

A doctor is allowed to prescribe medications for any purpose they deem valid. Because our medical licensing is pretty strict about doctors providing science-based care, that opening has generally meant the latter. But this opens the door to more bad information interfering with their practice.

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.

mgshamster: 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.

Speak for yourself. If necessary, I will pull myself by my bootstraps, buy the equipment, and learn how to work it, baby.

/I suppose you think you're not 'educated' enough to inspect meat, right?
//SOCIALISM SOCIALISM

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

mgshamster: Alt-med peddlers are likely celebrating the decision.

This.

Peddlers of false hope and cancer woo are scum of the earth, and deserve to be punched in the cock for what they do.

tricycleracer: If the ATF is monitoring the 50% ethanol claim, I'm down to buy a case. It would be a hit at parties.

If you're using anything less than 66% Alcohol Content as a hand sanitizer, you ain't doing shiat. 66-70% is the lethal range for most pathogenic microorganisms.

We have to use Alcohol/Chlorahexadine Based water less scrubs before we even set foot in the NICU or PICU at BronyMedic's job.

Wait, physicians and patients should make informed, intelligent decisions about drug prescription and use, and not simply buy into everything a 23-year-old rep who just graduated with a 2.8 GPA in marketing from the local state university extension campus has to tell them?

The more you know.

I find it humorous that at this point in the thread, everyone is floating in space, literally and figuratively...

tricycleracer: Fart_Machine: [3.bp.blogspot.com image 360x600] 

Ah the good old days....

If the ATF is monitoring the 50% ethanol claim, I'm down to buy a case. It would be a hit at parties.

/Is it laudanum? I hope it's laudanum.

Oo laudanum. I could go for some of that right about now.

mgshamster: 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.

You do realize you're a personal hero of mine on FARK for this stuff, right?

Indubitably: I find it humorous that at this point in the thread, everyone is floating in space, literally and figuratively...

Listen to whom you trust.

Woe be to you if you trust tired dogma.

For dogma is out, and new times are afoot.

Learn.

/Lots & lots of laudanum

FTA: "Moreover, it would seem that a serious blow has been dealt to the Food and Drug Administration's power to ensure the safety of prescription meds."

That would be tragic - if prescription meds were "safe" in the first place.

/They're not

JonPace: 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

The shiat of the real application of this, from experience, is that you are not a biochemist (in most cases), so when your doctor prescribes something for off-label use, you'll look it up, and by the by, find that it is a common off-label use, but not studies indicating its efficacy. The drug companies can test the efficacy of things on their own, and without FDA requirements for them to add it to the labeled uses, release the studies, often funded surreptitiously by the drug companies through outside research groups so they look independent. Sometimes (as with Neurontin) the fake research is good enough to even fool doctors.

And guess what, when you're poor, and you spent a good chunk of your income on a drug, even when you find out that the drug company knew the drug was ineffective, you might, if you fight hard for years on end and find a lawyer to take your case or join the class action, you just maybe might get a couple hundred bucks of compensation for the thousands you spent on the drug and the years that you weren't taking effective drugs because they did a good job duping you and your doctor. This speech is anything but free... I think it's cute of you to call people ignorant, when it's pretty plain to see you haven't the first idea of how bad the system is when big companies abuse it.

AliceBToklasLives: Meh, caveat emptor.

/why do we have the FDA anyway? It's restraint of trade.


On the contrary, the FDA is a safeguard of oligarchic monopoly.

Amos Quito: That would be tragic - if prescription meds were "safe" in the first place.

/They're not

And if you ever develop a medicine that is 100% safe, you'll win a noble prize. No medicine is 100% safe. Every substance - even giving something as simple as isotonic normal saline, is a trade off between risk and benefit.

On the other hand, neither are "herbal medicines". Anything with biological activity is going to do harm as well as good in some manner.

Of course, homeopathy is 100% safe. Because it doesn't do anything, period.

mgshamster: 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.


And even with all of those fun toys and elaborate skills, the makers and analyzers of these pharmaceuticals often (usually?) can't fully explain why certain drugs do what they (supposedly) do, let alone why they "work" on SOME people, but not others.

Innatrite?

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.

Amos Quito: And even with all of those fun toys and elaborate skills, the makers and analyzers of these pharmaceuticals often (usually?) can't fully explain why certain drugs do what they (supposedly) do, let alone why they "work" on SOME people, but not others.

Innatrite?

So because some people can't explain why certain drugs work, when they do, we don't need to regulate the pharmaceutical industry because consumers can let free market forces ddo the choosing for them?

If that's not your argument, then you really need to explain your position on this one.

Pharma companies can get WORSE in their deceptive and unethical marketing practices, and quacks can become more predatory on the desperate?

Wait. Does it support cancer or help promote cancer?

BronyMedic: Amos Quito: And even with all of those fun toys and elaborate skills, the makers and analyzers of these pharmaceuticals often (usually?) can't fully explain why certain drugs do what they (supposedly) do, let alone why they "work" on SOME people, but not others.

Innatrite?

So because some people can't explain why certain drugs work, when they do, we don't need to regulate the pharmaceutical industry because consumers can let free market forces ddo the choosing for them?

If that's not your argument, then you really need to explain your position on this one.

Pharma companies can get WORSE in their deceptive and unethical marketing practices, and quacks can become more predatory on the desperate?

Having been on the receiving end of Pfizer's farkjob with Neurontin, it's pretty hard to imagine how they could be worse in terms of deception and unethical marketing... commissioning hundreds of studies, publishing the few good ones, and throwing away the dozens with results you didn't like, all to push off-label uses of a drug you know is ineffective, and to circumvent FDA labeling requirements. They didn't just take my money, they took my chance to use effective drugs for several years away.

BronyMedic: Amos Quito: That would be tragic - if prescription meds were "safe" in the first place.

/They're not

And if you ever develop a medicine that is 100% safe, you'll win a noble prize. No medicine is 100% safe. Every substance - even giving something as simple as isotonic normal saline, is a trade off between risk and benefit.

On the other hand, neither are "herbal medicines". Anything with biological activity is going to do harm as well as good in some manner..


The determination of "safety and efficacy" of any drug is largely dependent on its patentability/profitability: No one is going to spend a billion dollars proving the "safety and efficacy" of a product that they can't patent and profit from.

Conversely, it is in the best interests of the makers of patented drugs to defame the "safety and efficacy" of any product that might tend to compete with their monopoly. No?

Ladies and Gentlemen, I give you PREMARIN, a "drug" (estrogens derived from horse piss) whose patent has held fast for decades.

[applause]

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.

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.

firefly212: BronyMedic: Amos Quito: And even with all of those fun toys and elaborate skills, the makers and analyzers of these pharmaceuticals often (usually?) can't fully explain why certain drugs do what they (supposedly) do, let alone why they "work" on SOME people, but not others.

Innatrite?

So because some people can't explain why certain drugs work, when they do, we don't need to regulate the pharmaceutical industry because consumers can let free market forces ddo the choosing for them?

If that's not your argument, then you really need to explain your position on this one.

Pharma companies can get WORSE in their deceptive and unethical marketing practices, and quacks can become more predatory on the desperate?

Having been on the receiving end of Pfizer's farkjob with Neurontin, it's pretty hard to imagine how they could be worse in terms of deception and unethical marketing... commissioning hundreds of studies, publishing the few good ones, and throwing away the dozens with results you didn't like, all to push off-label uses of a drug you know is ineffective, and to circumvent FDA labeling requirements. They didn't just take my money, they took my chance to use effective drugs for several years away.

That is exactly why pharmaceutical drugs need to be heavily regulated. Otherwise, they would do that shiat all the time (as compared to now, where they do it just when they think they can get away with it).

Conversely, the supplement industry is far less regulated than the pharmaceutical industry, and what you're complaining about with Pfizer happens all the time with supplements and alternative medicine. All they have to do is write "this product not approved by the FDA, and this product will not diagnose, cure, or treat any product (wink, wink)."

Amos Quito: 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.

What?

Thalidomide was never widely used in the United States BECAUSE of the concerns brought up to the FDA regarding it's teratogenicity and the lack of safety in Pregnant Women. It actually is a safe and effective drug for the conditions it's used for, however it's HIGHLY regulated to the point where you have to visit your MD every month for a refill, you have to have pregnancy tests, and you have to either be on birth control, or have your tubes tied. Every patient on it actually has to be on a nationwide patient registry through the FDA, and only a small amount of pharmacies can fill prescriptions for it.

Amos Quito: 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.

False comparison. Herbal supplements in concentrations to have a clinical effect have major side effects just like the drugs they are intended to replace. In addition, you can get toxicity from other compounds, or the plants themselves. NSAIDS like Vioxx WERE effective but dangerous drugs. We had studies that showed this, but they were downplayed by the drug companies, and a completely unethical and illegal marketing campaign touted them as safe for use in patient populations which they were explicitly contraindicated in.

Years later, there are still patients who have their VIoxx and Celebrex because they stockpiled them. They worked for them.

In addition, have you ever seen the side effect profile of Asprin, an Herbal Substance, and an NSAID? Or for that matter any salicylate? And yet it's one of the most cost-effective cardiovascular drugs on the market.

PPIs have their use. However, we have research showing their overuse and long-term use in ICU is harmful. Amazingly enough, it's driven practice changes in their use. On the other hand, Alternative Medicine quacks still promote vitamins, minerals, and supplements as effective for conditions which they have been shown worthless for.

It's all a conspiracy. They don't want you to know the truth, you know.

BronyMedic: mgshamster: 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.

You do realize you're a personal hero of mine on FARK for this stuff, right?

[i.imgur.com image 236x48]

Aw. Thanks. I did not know that. :)

You made my day.