Appeals Court Rules "Off-Label" Drugs Marketing is Free Speech

According to the Food, Drug and Cosmetic Act it's illegal to sell prescription drugs for any other purpose than what's written on the label. Consequently, Orphan Medical sales rep Alfred Caronia was criminally prosecuted for making "off-label" promotional comments about his pharmaceutical companies' drug Xyrem, a drug specified as a treatment for Cataplexy (weak and/or paralyzed muscles found in narcolepsy patients.)

Caronia, in a conversation taped by undercover government agents, told a doctor that the drug could also be used to treat other muscle conditions such as Restless Leg Syndrome and Parkinson's. In addition, he told the doctor that the drug could be used in patients under 16, notwithstanding the black box warning on the drug that highlighted that FDA standard safety has not been established for the drug in under patients under 16.

The information provided by Caronia was truthful. Despite this, he was prosecuted for breaking the law. Mr. Caronia successfully appealed the conviction this week arguing that his First Amendment right to free speech was wrongfully and illegally restricted by the drug law. 

Some observers are outraged by the appeal as they believe it endangers pharmaceutical regulation at-large. Dr. Andrew Kolodny, a New York psychiatrist, claims the decision is terrible for public health. "Off-label promotion is not about free speech, it is the medical equivalent of yelling fire in a crowded auditorium." Judge Debra Ann Livingston, the only dissenter on the appeal panel, agreed that such an overturning would be dangerous, suggesting "the majority calls into question the very foundations of our century-old system of drug regulation."

The Pharmaceutical industry, however, has embraced the decision arguing that off-label promotion can play an innovative role in health care provision. The Pharmaceutical and Research Manufacturers of America (PhRMA) issued a statement saying that they believe that "truthful and nonmisleading communication between biopharmaceutical companies and healthcare professionals is good for patients because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments."

The scope of the rulings effect ultimately remains in the hands of the Supreme Court, should they take up the appeal issue, and the government is expected to challenge the repeal in order to bolster the FDA's powers of regulation over the pharmaceutical industry.

Comments

[Fist of Etiquette]

All speech we don't like is the equivalent of yelling fire in a crowded theater.

[GroverinCA]

I pity the patients of Dr. Kolodny. May they successfully sue him for malpractice.

[A Mathematician]

If I owned a theater, could a make a rule saying patrons are allowed to yell "fire"? The reason people don't talk on cell phones in a theater is not because of the law; they don't talk on phones because it's the rules set by the theater.

[VG Zaytsev]

Depends on what part of town the theater is in.

[protefeed]

This is more like yelling, in a theater that is actually on fire, that there is another exit people can use to escape the fire -- and that assertion being true.

[C. Anacreon]

Yup. We docs use many meds
off label. Prior to this there have been billion dollar settlements just because reps would mention offlabel uses even when good practice. Hope this ends this.

[Pagan Priestess]

And off label isn't as weird as it might sound. For example, my son recently had surgery on his foot. The podiatrist prescribed a topical antibiotic steroid combination to keep the swelling and infection down, the labeled use: ear drops. It did what the doc wanted, in the way he wanted, so what if the label said it was made for ears; it worked just as well on a toe.

[mad libertarian guy]

How dare you use a drug contrary to how a bureaucrat in a suit who has never seen a patient in his life says you can.

[Rick Santorum]

This is more like yelling, in a theater that is actually on fire, that there is another exit people can use to escape the fire -- and that assertion being true.

Whoa, now, buddy. Wouldn't want the proles getting those kinds of ideas in their heads. They might decide to use the wrong exit. That might be problematic. What if other people start to use the wrong exit? No, no, we need to make sure they only use the right exit.

[Randian]

Ha ha: author of the decision is a Clinton/Obama appointee (Clinton nominated him to the Eastern District; Obama nominated him to the 2nd Circuit).

[Killazontherun]

Hard working, honest cops take these scumbags off the streets only to see liberal judges release them on these fancy lawyerly technicalities. It's enough to make a LEOfellator cynical.

[Hugh Akston]

I have yet to read about a justifiable undercover operation by any law enforcement agency anywhere.

[Dunphy (the real one)]

bwahahahahahahahahahahahahahahahahahahahahaha!

[SIV]

I liked the old robbery stakeout undercover operations where one cop would be the clerk in a grocery/liquor store while another hid in the back with a sawed off shotgun. Stick-up man comes in points gun and demands money. Cop in the back says "Police! Drop your weapon!".

More often than not, the scumbag would turn in surprise WITHOUT dropping his piece. Double-ought justice on the spot. No arrest, no jail, no trial, and no taxpayer-funded vacation at the penitentiary.Awful mess to clean up though.

This is what effective police work looks like. Armed robberies drop precipitously as stick-up men become an endangered species and criminals choose a different way to earn a living than sticking up store clerks.

They don't do it anymore (that I'm aware of) and I doubt too many of today's officers would have the nads to be the clerk.

[Eduard van Haalen]

"I doubt too many of today's officers would have the nads to be the clerk."

Why not? The clerks have the nads to be clerks. Are they supermen?

[tarran]

One step to immediately improve the public health in the United States would be to disband the FDA, fire its employees, and use the savings to reduce the public debt and eventually to reduce taxes.

The FDA blocks sick people from getting medical care. Full Stop.

The idea is that they are preventing them from getting access to medical care that hasn't yet been demonstrated as efficacious, but they suck at that. Instead they delay bringing products to market, increase the costs of launching new products and while the manufacturers jump through years' worth of delays, people who could benefit from the treatments being 'tested' suffer untreated.

Their elimination would unleash and explosion of innovation and consequently an improvement in health care - particularly in finding lower cost, more efficient ways to tackle providing treatments.

In the meantime, the billions of dollars saved on public expenditures are billions of dollars fewer in taxes required to balance the budget.

[SIV]

But...but...THALIDOMIDE!

[Sernylan]

FLIPPER BABIES!!!

[The_Choctaw]

Whats a few deformed babies matter I WANT MAH FREEDUM UH SPEECH!!

[Heroic Mulatto]

That is the most disingenuous argument possible.

[SIV]

Hence, the most common 😉

[ShagNasty]

An intersting fact about Xyrem is that it's active ingredient, GHB, is a schedule 1 drug. BUT when sold as the pharmecutical drug Xyrem, its considered to be schedule 3. Yes, US drug policy is that silly.

[BakedPenguin]

It's an interesting drug - bodybuilders use it (for obvious reasons, since it's used to repair / augment muscle tissue), but it's also a sleep aid and a recreational drug.

Prior to roofies, it was known as the 'date-rape drug' due to its sleep inducing ability.

[Hugh Akston]

You seem to know a lot about bodybuilding and rape.

[Episiarch]

Uh, that would be Warty. In fact, all he knows is bodybuilding...and good...and rape.

[db]

Tonight...YOU.

[Episiarch]

Can you back that up?

[ShagNasty]

I don't think it was ever commonly used as a date rape drug, I'm pretty sure that was all propaganda based on a handful of legitimate cases. It has a distinctive flavor and a dose weighs about 1.5-3 grams so it would be really impractical. Also bear in mind that 97% of date rapes involve no other drugs than Alcohol.

[Robert]

And I'll never understand why NaGHB (sodium oxybate) became the article of commerce when, without the high percentage of sodium that that form has, GBL does the same with that much smaller a dose. GBL in water tastes a lot like bourbon and has much the same effect but more tolerable. It's not surprising GBL would taste like bourbon, as it's present in wines. In the body, GBL and GHB rapidly equilibrate with each other. The brain is also producing some GHB from GABA all the time.

[Calidissident]

"legitimate cases"

I assume no one got pregnant from these legitimate rapes?

[John C. Randolph]

97% of date rapes involve no other drugs than Alcohol.

Wasn't that part of the original WCTU propaganda that let to prohibition?

-jcr

[Robert]

The whole "date rape drug" thing achieved notoriety with rohypnol, and that meme was around when people started widely using GHB similarly to rohypnol as a hypnotic. Supposedly the characteristic of these drugs that facilitates date rape is an anterograde amnesia that they reliably produce when enough is administered to produce stupor. To some extent that's true of most depressant drugs, most notoriously alcohol with its "blackouts", but some drugs better than others, and it's sometimes alleged to be an advantage of them when used for anesthesia during surgery -- like it's supposed to be a benefit to forget about your operation afterward! So the idea here is to make the person forget she's been raped.

[BakedPenguin]

That comment was about GHB, not Xyrem specifically.

[Agammamon]

Wait a minute - the point of schedule I is that those drugs have a high potential for abuse and *no medical use*.

The very fact that Xyrem exists, is approved by the FDA, and the DEA allows its prescription should, by definition, reschedule GBH.

[ShagNasty]

yeah, I'm hazy on the details, but I think it's considered to be a "different thing" for legal purposes, as if a corporation putting GHB in a pill and calling it Xyrem with FDA approval makes it not GHB anymore.

[Robert]

It's the same with THC depending on whether it's present in cannabis and its derivatives or synthesized and put into dronabinol (Marinol). I haven't looked it up, but presumably Xyrem is considered a particular form of GHB (defined by being in a tablet or some such) that's controlled separately. A legal fiction.

Meanwhile GBL is used in, among other ways, cigaret tobacco as a flavor additive. It's listed as 4-hydroxybutanoic acid lactone. It's a "watch list" chemical to DEA, yet AFAIK it's GRAS as a food additive to FDA. Also lots of use as a solvent. I got in a stock some years ago when I was experimenting with polyvinylpyrrolidone in bubble blowing solution and needed a solvent.

Caronia if anything understated it when he said it's as safe as Ambien. It's probably safer.

[SIV]

Heroin works as well or better than morphine and it is cheaper to make. It is only schedule I because of the stigma as a street drug.

[Bill]

Boy are you gullible. The whole point of Schedule I is so that politicians and drug regulators can look like saviors to the public. Also they help the media come up with scary headlines!

[Robert]

Schedule 1 was actually created at the behest of drug makers in the USA who didn't like the p.r. of their narcotic drugs being in the same category as heroin. Previously there'd been 4 classes (labeled by letters similar to the MPAA code's), with morphine and heroin in the same class, although heroin was not licensed for medical use.

[Trespassers W]

Caronia... told a doctor that the drug could also be used to treat other muscle conditions such as Restless Leg Syndrome and Parkinson's.

Well, at least the government TRIED to do something about this obvious sociopath.

[Sevo]

..."it is the medical equivalent of yelling fire in a crowded auditorium."...

Hmm. Officer, arrest this guy for felony hyperbole.

[Dunphy (the real one)]

note, it's FALSELY yelling fire.

it's also a tired meme to say the least and not even current law.

[Agammamon]

Yeah, yell "fire" in a crowded theater - that is actually on fire - and let someone get hurt in the rush to leave and we'll see how legal it is.

You can try to explain to the DA Shooting for higher office why that wasn't depraved indifference or why you weren't interfering with the duties of fire/police.

[db]

That's why you get up calmly, walk to the exit, and then yell "fire."

[iggy]

What if I start the fire and THEN yell fire? That should be okay, right?

[Generic Stranger]

Popehat on why "yelling fire in a crowded theater" adds nothing to the first amendment debate.

TL;DR version: The quote is from an opinion that tried to justify government censorship in wartime that is no longer considered precedent, and has since been disowned by its author.

[Juice]

Can't someone just say "now this opens the door to all sorts of snake oil salesmen saying that guzzling hand sanitizer cures AIDS" or something like that?

[Robert]

It does! And that's what's so fucking great about it!!!

Seriously, the most important thing in Caronia is the 1-judge dissent. What she says is right. And that's what makes it stunningly great!

[Hugh Akston]

Anyone who falls for that deserves what they get.

Everyone knows you cure AIDS by butt-chugging hand sanitizer.

[iggy]

The issue here is that everything he said was accurate. You couldn't say 'guzzling hand sanitizer cures AIDS' because that's not true.

[Robert]

How do you know it's not true? The question is, is the represent'n made in good faith?

[Rick Santorum]

How do you know it's not true? The question is, is the represent'n made in good faith?

Are you seriously comparing saying "this drug can be used to treat this condition" and "HAND SANITIZER CURES AIDS."

Please tell me you aren't that autistic.

[darius404]

Please tell me you aren't that autistic.

Well someone woke up on the wrong side of the Buttplug.

[Robert]

In terms of medical rx, there's practically no such thing as "true"; rather it's how much reason you have to believe something. If you don't believe it yourself, then you're lying about it, making a statement in bad faith. If you do believe it yourself, someone else still might not, but that doesn't make yoru statement about it a lie. There's so much uncertainty in medicine, it could scarcely be otherwise.

[Hugh Akston]

Dr. Andrew Kolodny, a New York psychiatrist, claims the decision is terrible for public health. "Off-label promotion is not about free speech, it is the medical equivalent of yelling fire in a crowded auditorium."

Three generations of quoting Oliver Wendell Holmes is enough.

[ant1sthenes]

I at least wish that they would acknowledge that he was saying that people should go to jail for criticizing the draft.

[Bill]

Good point. I had forgotten this and just re-learned it. Thanks.

[mad libertarian guy]

And not even criticizing all that harshly. The anti-draft pamphlets were little more than simply saying 'the draft is bad."

[Eduard van Haalen]

and unconstitutional. Can't have that.

[Hyperion]

Meh. I am home, on a Friday evening, with beer and nothing to do, wifey is watching something stoopid on TV. Come on Reason, post something half way interesting or I am going to have to think up something to hijack this crappy thread or start gaming. And you guys want donations, right before Christmas, my wedding anniversary, and both mine and my wifes birthdays, of all times.

[Killazontherun]

I feel ya. I'm home drinking beer and playing on the PSIII (Dynasty Warriors -corny dialog and boring game play) with my nephew. The wife is at work, and I'm somewhat watching the kid. Actually, he's playing with his cousin in the den. My teenage cousin and neighbor got knocked up a few years ago at the same time my wife did, so I pay her to sit because I hate yucky diapers and she could use the money.

[Episiarch]

Fuck you both, you complaining little bitches. I'm at work still. Of course, I'm still riding the buzz from the beer I had at lunch and I'm not actually doing any work but instead watching videos of how to kill particular bosses in Borderlands and clips from terrible, terrible movies. BUT I'M STILL AT WORK.

[Hugh Akston]

So I'm the only one on the west coast who's still at work and still working?

Also Borderlands is lame.

[Gojira]

I'm in the central time zone and still at work.

[Hugh Akston]

I'm sure all the drive-thru customers at Steak n' Shake are grateful for your dedication, Jimbo.

[Episiarch]

JJ works on his back, Hugh. Or his stomach. He works prone, is what I'm trying to say.

[Gojira]

Hey, you can't beat having wifi access and letting me post on here while I'm flipping burgers.

Livin' the dream man, livin' the dream.

[Episiarch]

You're lame.

[EDG reppin' LBC]

Simply awesome. Thank you for posting this. My wife and I love terrible movies. We're going to watch this online tonight.

http://www.1channel.ch/watch-1.....Connection

[EDG reppin' LBC]

Well that may have been the single worst movie I have ever watched. Hilarious!

[Jim K]

worse than Star Trek II?

[EDG reppin' LBC]

Yes. Besides, you're just trolling for conversation and know that Star Trek will liven up things around here.

[Jim K]

Why would the mere mention of Star Trek do such a thing?

[EDG reppin' LBC]

Why would the mere mention of Star Trek do such a thing?

New to these threads, are we? Here is a list of topics that will bring out some lively discussion:

Star Trek
Circumcision
Abortion
Deep dish vs. "real" pizza
Beer
Atheism vs. Agnosticism vs. Religion
Artisanal Mayonnaise
Definition of "Prog Rock"
Should Rush be in the RnR Hall of Fame?
Is British syntax/grammar/spelling acceptable?
What the fuck is wrong with Canada?
Food trucks
The Civil War
George Zimmerman

[Ted S.]

You forgot to mention the monsters from An Ohio State University.

[JW]

Is that Buck Norris?

Seriously, I don't remember the 80's being that awful.

[Hyperion]

I have to side with Epi on this one, Borderlands is awesome so far. Took me a couple of hours to decide that. The sound track is incredible, nice artsy graphics, very different, and the killin is sweeeet! Addictive as hell. I will be playing a lot tonight.

[JW]

I just finished about a 3 hour session. Level 46 with a bullet, baby!

BTW, Shift has a shiftload of key codes tonight.

Since Claptrap won Character of the Year ?SHiFT codes to celebrate!

In celebration, tonight's codes will be active through the whole weekend!

For more about Golden Keys and how to redeem them, visit http://bit.ly/RZzXaC
Let's celebrate Borderlands 2 winning Best Multiplayer with some SHiFT codes!

PC / Mac: C3C3J-KFTHW-WX3JJ-3BTJ3-ZR6B9
Xbox 360: WTWTJ-ZRHCZ-RZXJ6-5XJJB-ZKKH3
PlayStation 3: C3CBT-BT695-BWCKT-S3KBT-BCSSR

PC / Mac: K3KJ3-3RT95-KXB3B-BBTBT-CB6KH
Xbox 360: CJ53B-66ZC9-RZR3X-5XJB3-JHC5T
PlayStation 3: 5T5J3-ZHWSW-3K5K3-SJCJB-SCRFB

PC / Mac: W3KTT-ZW39K-56TJ3-J333T-X9FKH
Xbox 360: KJCBB-CXSWH-6ZXT6-WXTBJ-RSHHZ
PlayStation 3: 5J5B3-FZC9W-JC5C3-STC3B-6TF3W

PC / Mac: 5TCTJ-XC3S5-C6JJT-3JTTT-HFBW9
Xbox 360: CT5TB-B6HWS-XSR3F-KR3BB-H6B6R
PlayStation 3: KJ53T-CZWZK-3KC5J-HJC3T-HCC59

PC / Mac: WTKT3-BSJSK-5XBTT-B333T-963SF
Xbox 360: CBWTT-SBFSK-35WKT-HB5TT-RRRHH
PlayStation 3: K3W33-5SX95-35K53-935T3-H6WW6

[Hyperion]

Haahahaha, serves you right, Epi, you Biaatchh, fer talking me into buying that dern Borderlands game. Damn soundtrack is like some sort of a hypnotic drug, and the game is addictive as fuck. I killed that nine toes dude a few minutes ago.

Are you smoking some herb when you are playing that? Cause it makes me want to smoke some and I haven't smoked any herb in many moons.

[Episiarch]

I told you it was tons of fun. No shit it's addictive. I wish I had more time to play. But tonight I have to lift and then company holiday party time...at a karaoke bar. I wonder what I'll sing? I'm thinking "The Final Countdown".

I don't smoke weed any more. But I do drink martinis while playing. Oh yes I do.

[Hyperion]

You talking about that song from the 80s.... early 90s? What was the name of that band? Something about Europa...

You can sing that?

[Episiarch]

I can sing anything. How it sounds varies. And the band is Europe.

[Hyperion]

Well, shit, I can sing anything also, just that it sucks mostly.

[Hyperion]

I can sing anything

Dude, then you have to do ain't no rest for the wicked as your tribute to Borderlands. Just do it, or you're stupid!

[Killazontherun]

I fucking love the bus scene.

[Gojira]

I don't smoke weed any more.

Pfft, what, once it became legal it wasn't "edgy" enough for you anymore? Queer.

[Hyperion]

Fuck! He lives in WA doesn't he?, or is it OR? Shit, if I lived there, in WA, I would have lit up under the Space Needle just to say a giant FU to the feds.

[Episiarch]

I'm the hipster-est monster since hipster came to Hipstertown!

[Hyperion]

I'm the hipster-est monster since hipster came to Hipstertown!

Then you will karaoke ain't no rest for the wicked, or else you suck.

[Killazontherun]

Last time I did karaoke, this was the tune.

[darius404]

I think my favorite part was the World's Largest Bullet. Best. Tour. Ever. Worth every dollar. Take the tour as soon as you find it. It's only in The Secret Armory of General Knoxx DLC though.

[iggy]

I'm deeply sorry that Reason didn't ask you what time of year would be best for you to donate. That was thoughtless of them.

[Hyperion]

Damn right, fuckers.

[Hyperion]

Well, and you do know that most of us have Christmas at the same time of year, right? And there's this pesky tradition that requires us to spend lots of $$$ on presents for other people, and stuff. Oh, and drink more alcohol than normal, there is that also.

[iggy]

Maybe they were assuming that everyone would be super drunk around Christmas and would accidentally donate to reason in an alcohol induced fugue state.

Those libertarians sure can be sneaky.

[darius404]

I have the perfect pitch, too:

Got a special milestone or event coming up?

Instead of another gift card you'll forget to use, ask your friends and family for something that will go a little further: a donation to Reason for America. Register your next celebration?whether it's a birthday, bar or bat mitzvah, wedding, or anniversary?with Reason magazine. It's a great way to show your support for a cause that's important to you on your big day.

[Sevo]

How about a juicy CA gov't boondoggle?
In response to Bush's ban on further embryonic stem cells, the CA voters decided to show him! So they cut off their noses and sent them to a gov't agency to hand out to, well, who knows.
Anyhow, they've been blowing the dough and now want to fund a 'study' to find out how to keep their cushy jobs:
"It also asked that the review consider how the agency's responsibilities might change in the long term, especially after it runs out of public money. In theory, the agency could request more public funding in another statewide vote, or look for alternative funding sources."
http://www.sfgate.com/default/.....098508.php

Read more: http://www.sfgate.com/health/a.....z2EPk14rHD

[darius404]

But they got back at their faces, and that's the important thing, right?

[Archduke Pantsfan]

Find a crappy movie on Netflix and post about it while you watch it.

[Killazontherun]

Wife wanted me to call Netflix customer service because a movie has been delayed for two months. I hate talking on the phone but this was going to be fun because I had a brown M&M of my own I've been keeping around. I tell the guy the situation, and he gives the spew that you would expect. I say, 'well, I guess since there is nothing you can do about that, you wont be able to anything about 'Things To Do In Denver When Your Dead.' He digest this, and discovers why I pointed out. It's been on my list since 2008. He sputters with an obscene degree of apology, and promises to raise it to his manager's attention. I got both of the movies this week. 'Denver' was in the okay to good range. Terrific acting in numerous scenes, the one introducing Christopher Lloyd being a standout, but a few distractions I wished they left out to extend the more active part of the narrative. And it fulfilled my search for young Gabrielle Anwar sightings for the month.

[Hyperion]

Have you ever seen Gummo?

[Episiarch]

DON'T TALK SHIT ABOUT GUMMO

I love that movie. The scene where the drunk guys aggressively beat up the chair is fucking amazing. You know that most of the "actors" in that were locals, right?

[Hyperion]

Dude, I was in Cincy the day that tornado hit Xenia.

You just like the part where the 13 year old girls are using duct tape on their boobs, right? Just admit it, you perv!

[Killazontherun]

Sorry, can't talk about that.

[Killazontherun]

Chloe use to be so cute.

[Robert]

He wasn't given prominent play in the movies. I know of only one that he was in.

[Hyperion]

One of the best unexpected movies I have ever seen on Netflix is a Brazilian film named 'O Homem do Ano' - The Man of the Year. I think it is in English on there. Well worth watching, great film.

[EDG reppin' LBC]

Thanks for the heads up about Man of the Year. I'm going to watch that in a few minutes. But if it sucks, I'll reach through my monitor and knock your beer over into your keyboard.

Also, are you a Los Angeles area Reasonoid?

[Hyperion]

Balmer, hon. I lived in LA for 5 years, well, outside of LA, Simi Valley, long time ago.

[EDG reppin' LBC]

Ohhhhhhh. Rightrightrightrightrightrightrightright. I forgot you were in MD. I was just curious because your handle is Hyperion, and there are a few landmarks around LA with the Hyperion handle.

[SIV]

I miss Tim Cavanaugh posting witty,well written, link-rich pieces with the pixels still wet at oddly late hours. Seems like Reason has gone to a 9-5 posting schedule with scheduled canned stuff 7-9 AM. Maybe everything has to clear Matt or KM-W or Nick now but it seemed like editor/contributors used to occasionally turn in their homework fresh and late.

[Jim K]

DRINK!!

[Hyperion]

You're late to the party. I've been here drankin since 6pm EST.

[EDG reppin' LBC]

*clinks martini glass

[Pinky]

Judge Debra Ann Livingston said, "the majority calls into question the very foundations of our century-old system of drug regulation."

By trumping it with our two century old system of first amendment rights! Yeah Baby!

[iggy]

Who cares about either of those things? They're both over a hundred years old!

[Archduke Pantsfan]

It's Always Sunny in Homeland

[Jim K]

What are you all doing tonight? I just finished baking some amazing gluten free chocolate orange shortbread for the bake sale tomorrow!

[Hyperion]

gluten free shortbread? FTW? Bake sale? You fucking with us, dude?

[Jim K]

why would I do that?

[Hyperion]

I dunno. Cause you're bored? Why the fuck else would someone be posting about shortbread and gluten free shit? Is there any weed in da shortbread?

[Jim K]

can't a libertarian like making gluten free shortbread?
is there a code?

[Hyperion]

NO! Not unless it has weed in it. Or maybe some explosives.

[Jim K]

you probably hate bake sales too.

[Hyperion]

you probably hate bake sales too

I totally do, unless they are being done by hot girls in bonnets who don't shave their legs, and are also selling porn and moonshine under the counter.

[Jim K]

bake sales are totally free market. no coercion whatsoever.

[Hyperion]

And bersides, there is no fucking body here. Reason writers are out somewhere counting all the money that they just conned us out of, and all of the posters here are watching Episiarch do gay karaoke by a band named Europa.

[General Butt Naked]

Not me!

I'm drinking cheap beer, listening to House of Pain, and thinking about all the people that I've smacked in the mouth!

Like a man does.

[Hyperion]

But, the question is.... have you ever ate the still beating heart of your slain enemies, while you were fighting nekked?

[General Butt Naked]

YES. To gain their powers!

The only powers my enemies seem to have, though, is violently vomiting when eating nasty ass raw bloody heart.

[Jim K]

sounds awful violent. coercive like violence.

[General Butt Naked]

There are three types of libertarians out there.

One believes in spreading the message through the soap box.
Another uses the ballot box.
And some choose the murder box.

We all have our ways, don't judge.

[AlmightyJB]

You forgot the about the ones who just like to watch the world burn.

[Hyperion]

sounds awful violent

Alright dude, first bake sales and now this anti-violence rhetoric.... I am a gettin mighty suspicous bout you. We don't take kindly to no .... anybody.... round here...

[Jim K]

ain't nothin' more coercive than killing a man.

[General Butt Naked]

Deserve ain't got nuthin' to do with it.

Just wanted to say that, and it seemed to fit.

[Hyperion]

YES. To gain their powers!

Well, then you are ok, welcome to the cloob.

[Hyperion]

I'm drinking cheap beer

What is cheap beer? Please tell me that means Heineken(my favoritist cheep beer) and not coors light, which is not beer, but dog piss with a trace amount of alcohol in it.

[SIV]

I enjoy the occasional 24oz can of regular Coors "Banquet Beer". Especially as a .$99 iced-down special from some ghetto mart where they want $8 for a 6 of Bud.

Coors Light sucks for anything other than washing down 'script analgesics.

[Hyperion]

I can't drink any American mass produced lager beer, not any of it. It makes me gag even when ice cold. It has a strange chemical taste, that I never noticed until I hadn't had it for years. Blecch!

[General Butt Naked]

Dude, Heineken is like thirty eight bucks a case here. I ain't drinkn' for the taste; I wants to get fucked up.

I drink the real nasty shit: Pabst, Busch, Old Milwaukee(not milwaukee's best though, i have some standards) yuengling in a can, etc...

Never light beer, ever. If I have money I'll buy Guinness, it's the only fancy beer I like. All that other shit tastes like rotten cake.

[Hyperion]

WTF??? Where the hell do you live? I am in MD and it's $19 a case here at the big emporium type store if I want to drive 8 miles. Mile down the road it's $22 a case.

Yuengling is ok, I can get that for $15 a case here.

[Trespassers W]

That sounds good, but you know what would make it better?

Shitload of gluten.

[Hyperion]

And weed

[AlmightyJB]

And Bacon

[Jim K]

unlike the others, bacon isn't a vegetarian friendly option. why do you impose your meat eating ways on everyone?

[darius404]

Micro-aggression! DRINK!

[Trespassers W]

Welp, I just killed off a bottle of Art of Darkness, and so I have this to say:

COUGH UP YOU SKINFLINTS

[Hyperion]

bottle of Art of Darkness

That sounds dark and artsy. WTF isit?

[Trespassers W]

A Belgian dark ale brewed by Ommegang.

[John C. Randolph]

Some observers are outraged by the appeal as they believe it endangers pharmaceutical regulation at-large.

And the downside of that would be what, exactly?

-jcr

[Hyperion]

edzachary nuffin, hon

[SIV]

Man I'm gettin' old when this sounds hot:

Nigella Lawson's workout routine

[Hyperion]

Looks good to me, she's same age as me and wifey, so I suppose that's normal for me for her to look good. But to be honest, I remember plenty of 40 something women who I thought was hot when I was in my 20s... 50 somethings seem to have looked old back then, maybe it's an evolution thing, or just age, but I see lots of 50 something year old women that look hot to me now.

[AlmightyJB]

I think she's very sexy. She's not afraid to be woman.

[Jerryskids]

Sucks that the link goes to such a poor take on the story. I mean, right off the bat the headline bemoans the fact that 'public health' fails to trump that nasty old first amendment crap. And then the big lie - that this very post blandly repeats - that "it's illegal to sell prescription drugs for any other purpose than what's written on the label".

No, it's not. It's called off-label use. It is legal for your doctor to prescribe Viagra to cure your pink-eye and legal for your pharmacist to fill that prescription. What's *not* legal is for Pfizer to *promote* Viagra as a cure for pinkeye - even if their clinical trials indicate that Viagra does actually cure pinkeye.

With this decision Pfizer is now free to promote Viagra as a cure for pinkeye, right? Well, no - that would be fraud, which is still illegal. Unless, of course, Viagra does actually cure pinkeye, in which case, why the hell shouldn't Pfizer be free to inform doctors of this fact?

The American Enterprise Institute has a better article on this issue - making a good point that the pharmaceutical companies are deathly afraid of the FDA and aren't likely to be pushing the envelope on freeing up the drug market. (Because the FDA are the sort of nazi nannies with guns and badges that will fuck. you. up. if you dare to question their authoritah.)

[Robert]

No, it was illegal to sell it for off-label use. It wasn't illegal to use it that way, though. It all goes to the state of mind of whoever's selling it, not whoever's buying it -- except in the case of human growth hormone.

[waaminn]

Sometimes you jsut gotta roll with it.

http://www.AnonTyme.tk

[??? ??????]

thank you

[waaminn]

Dude is not making a whole lot of sense.

http://www.AnonTyme.tk

[hair follicle drug test]

Thanks for the useful info. well done and arranged very good.

[Dorris]

This had to happen along time ago. These days anyone can supply themselves with any drug they want, just because they have "someone" who they know at the drug store or their doctor can prescribe for their needs.

I totally sustain this act and hope order can be once again respected. I have watched and documentary movie on http://www.onchannel.net/54165-how-drugs-work.html about this subject, hope you can watch it too

[WendiBush]

Off label drugs shouldn't be sold, as surely they won't be clinically tested that's why they are off label.
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