Now that's a fine!
http://www.valuewalk.com/2012/07/glaxosmithkline-pleads-guilty-illegal-drug-marketing-to-pay-3b-fine/
QuoteGlaxoSmithKline Pleads Guilty illegal Drug Marketing, to Pay $3B Fine
July 2, 2012
By Tabinda Hussain
The biggest player of the pharmaceutical industry, GlaxoSmithKline plc (NYSE:GSK), makes the biggest settlement of healthcare fraud in US trial history. This brings an end to a long-running case against the pharmaceutical giant that was under investigation for many years now. FDA, FBI and Department of Health and Human Services had been probing the matter.
The drugs that the company is paying a huge price for are called Paxil, Wellbutrin and Avandia. While Paxil and Wellbutrin are antidepressants and the criminal charges are 'misbranding', GlaxoSmithKline plc (NYSE:GSK) faced allegations of misrepresenting the drug safety data, in case of Avandia. The settlement includes a payment of $1billion to compensate for criminal fraud and $2billion for civil liabilities such as the pricing fraud surrounding all three above mentioned drugs. The many complaints filed in the US vs GSK lawsuit were:
GSK failed to quote safety data on Avandia when the company clearly knew that its use could elevate risk of heart failure.
Paxil was illegally promoted to patients under 18 when the drug wasn't approved for this age group.
The U.S. court also alleged that the company published and distributed a misleading content in medical journals and grossly misrepresented the drug's efficacy.
GSK sponsored doctors with payments, lavish parties and other luxuries to promote the prescription of Wellbutrin.
The CEO of GSK, Andrew Witty was quoted as saying in a company post-settlement statement, ""Today brings to resolution difficult, long-standing matters for GSK, Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made."
GSK made the largest pay-off but it is certainly not the only one, previously Pfizer Inc. (NYSE:PFE) and Eli Lilly & Co. (NYSE:LLY) have paid $2.3 billion and $1.4 billion in separate settlements.
:hmm: I know fellows who pleaded guilty to illegal drug marketing and got 70 to 84 months...
Quote from: Capetan Mihali on July 02, 2012, 09:27:33 PM
:mmm: I know fellows who pleaded guilty to illegal drug marketing and got 70 to 84 months...
It's different when it's a corporation, though. Since corporations are people, the other people inside them never have to go to jail.
Quote from: jimmy olsen on July 02, 2012, 09:02:39 PM
Paxil was illegally promoted to patients under 18 when the drug wasn't approved for this age group.
I took Paxil as a teenager. Where's my cut?
Quote from: CountDeMoney on July 02, 2012, 09:48:39 PM
Quote from: Capetan Mihali on July 02, 2012, 09:27:33 PM
:mmm: I know fellows who pleaded guilty to illegal drug marketing and got 70 to 84 months...
It's different when it's a corporation, though. Since corporations are people, the other people inside them never have to go to jail.
We should have the reverse logic...if corporations are people, then when guilty of a crime, send everyone who works for the corporation to a penal camp.
Sure, Seedster, let's try for a world without pharmaceuticals.
Quote from: garbon on July 02, 2012, 10:22:28 PM
Sure, Seedster, let's try for a world without pharmaceuticals.
How's this for a fucking change; sending assfucks from corporations to jail, instead of taking their money in exchange of a waiver of civil liability and immunity from prosecution so they can do it all over again sometime? How bout that, you fucking hack?
Avandia coming up again, eh? My former employer conducted much of the Phase III trial for GSK. I think the official corporate line was, "We only collected the data, we didn't interpret it."
Quote from: CountDeMoney on July 02, 2012, 10:35:22 PM
Quote from: garbon on July 02, 2012, 10:22:28 PM
Sure, Seedster, let's try for a world without pharmaceuticals.
How's this for a fucking change; sending assfucks from corporations to jail, instead of taking their money in exchange of a waiver of civil liability and immunity from prosecution so they can do it all over again sometime? How bout that, you fucking hack?
What's interesting is how quick you are to side with the morass of an organization that is the FDA. Not surprising though, you seem to have some hard-on for government agencies as if the talentless fucks that suck on the government teat do so out of altruism.
Quite frankly if there is an off-label drug that would help me if I'm someday suffering from a malady, I'm glad that someone gets the word out there given that off-label might just mean that the FDA didn't like the formatting of the document that presented the clinical trial results.
Now is it right for companies to end-run around the rules that they say they will abide by - certainly not. But it's hardly surprising that some people may take that upon themselves when dealing with a hostile public that is yet all to happy to lap up drugs that help them - regardless of an indication...as well as dealing with the bloated bureaucratic organ that is the FDA.
Side note - Wellbutrin: :x
What's wrong with Wellbutrin?
Quote from: Capetan Mihali on July 02, 2012, 11:41:41 PM
What's wrong with Wellbutrin?
While it's a common intro drug - it can also have some jarring side effects...especially the withdrawal!
Quote from: CountDeMoney on July 02, 2012, 10:35:22 PM
Quote from: garbon on July 02, 2012, 10:22:28 PM
Sure, Seedster, let's try for a world without pharmaceuticals.
How's this for a fucking change; sending assfucks from corporations to jail, instead of taking their money in exchange of a waiver of civil liability and immunity from prosecution so they can do it all over again sometime? How bout that, you fucking hack?
Cause he was one of those assfucks, that's why. It was true 100 years ago, it's still true today.
QuoteCORPORATION, n.
An ingenious device for obtaining individual profit without individual responsibility.
http://www.alcyone.com/max/lit/devils/c.html
Quote from: garbon on July 02, 2012, 11:10:23 PM
Quote from: CountDeMoney on July 02, 2012, 10:35:22 PM
How's this for a fucking change; sending assfucks from corporations to jail, instead of taking their money in exchange of a waiver of civil liability and immunity from prosecution so they can do it all over again sometime? How bout that, you fucking hack?
What's interesting is how quick you are to side with the morass of an organization that is the FDA. Not surprising though, you seem to have some hard-on for government agencies as if the talentless fucks that suck on the government teat do so out of altruism.
At least the FDA is a government agency, answerable to elected officials, who also happen to be answerable to us.
QuoteNow is it right for companies to end-run around the rules that they say they will abide by - certainly not. But it's hardly surprising that some people may take that upon themselves when dealing with a hostile public that is yet all to happy to lap up drugs that help them - regardless of an indication...as well as dealing with the bloated bureaucratic organ that is the FDA.
More prosecution, less Mickey Mouse fines with waivers from civil and criminal liability.
That's the only way the private sector, from Wellbutrin to Wall Street, will ever learn to Do The Right Thing. The private sector will never willingly do it, institutional morality forever cockblocked by greed, so the only credible alternative is government regulation combined with the very real threat of going to Federal Pound Me In The Ass Prison.
The thread title is quite misleading, considering it was the marketing that was illegal, not the drugs.
Quote from: Martinus on July 03, 2012, 01:39:36 AM
The thread title is quite misleading, considering it was the marketing that was illegal, not the drugs.
:mellow:
Quote from: The Brain on July 03, 2012, 01:48:48 AM
Quote from: Martinus on July 03, 2012, 01:39:36 AM
The thread title is quite misleading, considering it was the marketing that was illegal, not the drugs.
:mellow:
What?
Quote from: CountDeMoney on July 03, 2012, 01:10:17 AM
More prosecution, less Mickey Mouse fines with waivers from civil and criminal liability.
Since when is $3,000,000,000 a Mickey Mouse fine!? :huh:
Quote from: jimmy olsen on July 03, 2012, 01:59:12 AM
Quote from: CountDeMoney on July 03, 2012, 01:10:17 AM
More prosecution, less Mickey Mouse fines with waivers from civil and criminal liability.
Since when is $3,000,000,000 a Mickey Mouse fine!? :huh:
Well, it's less than 10% of their 2011 revenues (which is the kind of fines you pay in normal antitrust investigations which do not carry a civil or criminal immunity with them) so it's not exorbitant. And obviously it will be felt mainly by the shareholders since it's going to eat up almost the entire distributable dividend for 2011, the employees and executives having already received their pay and bonuses.
Pharmaceutical companies are like fucking angels sent from heaven to help you benighted souls, and ease your suffering.
This has nothing to do with the fact that my livelihood comes indirectly from a pharmaceutical company, and frankly I'm shocked that you'd make such an ad hominem attack. For shame.
Quote from: jimmy olsen on July 03, 2012, 01:59:12 AM
Since when is $3,000,000,000 a Mickey Mouse fine!? :huh:
When it buys civil and criminal liability.
Quote from: CountDeMoney on July 03, 2012, 01:10:17 AM
At least the FDA is a government agency, answerable to elected officials, who also happen to be answerable to us.
Yes and we seem to love electing and re-electing corrupt ones. (see: Rangel, Charles)
Quote from: CountDeMoney on July 03, 2012, 01:10:17 AM
That's the only way the private sector, from Wellbutrin to Wall Street, will ever learn to Do The Right Thing. The private sector will never willingly do it, institutional morality forever cockblocked by greed, so the only credible alternative is government regulation combined with the very real threat of going to Federal Pound Me In The Ass Prison.
I've more faith in getting the goods and services I need from private enterprise than Capitol Hill.
Also I wonder at a multinational like GSK if the CEO personally approves all marketing/sales efforts for every brand.
Quote from: Martinus on July 03, 2012, 01:54:50 AM
Quote from: The Brain on July 03, 2012, 01:48:48 AM
Quote from: Martinus on July 03, 2012, 01:39:36 AM
The thread title is quite misleading, considering it was the marketing that was illegal, not the drugs.
:mellow:
What?
Stop parsing the sentence the way that you are reading it.
You see:
Illegal Drug Marketing
We see: Illegal
Drug Marketing
Quote from: garbon on July 03, 2012, 08:47:37 AM
Quote from: Martinus on July 03, 2012, 01:54:50 AM
Quote from: The Brain on July 03, 2012, 01:48:48 AM
Quote from: Martinus on July 03, 2012, 01:39:36 AM
The thread title is quite misleading, considering it was the marketing that was illegal, not the drugs.
:mellow:
What?
Stop parsing the sentence the way that you are reading it.
You see: Illegal Drug Marketing
We see: Illegal Drug Marketing
I think it can be legitimately read both ways, especially if you consider that several people made jokes/comments implying they read it (whether in jest or seriously) my way. The way I see it, news headlines should avoid ambiguity.
Quote from: Martinus on July 03, 2012, 09:52:25 AM
The way I see it, news headlines should avoid ambiguity.
Good thing no one cares how you see it. :)
Quote from: garbon on July 03, 2012, 08:47:37 AMStop parsing the sentence the way that you are reading it.
You see: Illegal Drug Marketing
I like to think the newspaper would have phrased that "Marketing of Illegal Drugs"
Quote from: garbon on July 03, 2012, 08:46:18 AM
Quote from: CountDeMoney on July 03, 2012, 01:10:17 AM
At least the FDA is a government agency, answerable to elected officials, who also happen to be answerable to us.
Yes and we seem to love electing and re-electing corrupt ones. (see: Rangel, Charles)
Representative democracy, Susie. It's what's for dinner.
QuoteI've more faith in getting the goods and services I need from private enterprise than Capitol Hill.
Yeah, because private enterprise always has your best interests in mind. Sucker.
QuoteAlso I wonder at a multinational like GSK if the CEO personally approves all marketing/sales efforts for every brand.
Who gives a fuck. Somebody needs to be held accountable. and sometimes they need to be prosecuted.
Quote from: Syt on July 03, 2012, 09:58:27 AM
Quote from: garbon on July 03, 2012, 08:47:37 AMStop parsing the sentence the way that you are reading it.
You see: Illegal Drug Marketing
I like to think the newspaper would have phrased that "Marketing of Illegal Drugs"
I guess I don't hold ValueWalk to the same standards as you. Looks like essentially an internet blog with articles by many non-native speakers.
Quote from: CountDeMoney on July 03, 2012, 09:58:47 AM
Representative democracy, Susie. It's what's for dinner.
So then you can see why I've little faith in the gov't or the FDA in these matters...and the thought that we have little control over them.
Quote from: CountDeMoney on July 03, 2012, 09:58:47 AMYeah, because private enterprise always has your best interests in mind. Sucker.
Thankfully my physician does the prescribing, not the pharma company. Not so bad if my doc has more information than less.
Quote from: CountDeMoney on July 03, 2012, 09:58:47 AM
Who gives a fuck. Somebody needs to be held accountable. and sometimes they need to be prosecuted.
It is very relevant. Doesn't seem fair to convict someone of a crime they didn't commit. :huh:
Quote from: garbon on July 03, 2012, 10:08:31 AM
Thankfully my physician does the prescribing, not the pharma company. Not so bad if my doc has more information than less.
:rolleyes: Corporations are teh evol, docs are teh wholesome and altruistic. Sure.
Remember Pfizer getting busted for this? Remember how much fallout there was from doctors that lost their medical licenses over improperly prescribing based on the perks they were getting from their drug reps?
You go to the doctor. He submits claims to your insurer, who are going to find any and every reason they can not to pay and stick the doctor with a tab on you that may or may not get settled when it goes to collections. The same doctor gets all kinds of comps from his drug reps; whose interests do you think the doc is going to favor?
Quote from: garbon on July 03, 2012, 10:08:31 AM
It is very relevant. Doesn't seem fair to convict someone of a crime they didn't commit. :huh:
They're still responsible. Being the boss is about more than the seven-figure salary and the private jet. We live in a wonderful time for removing the freedom of action from your subordinates via technology.
Quote from: DontSayBanana on July 03, 2012, 10:52:46 AM
Quote from: garbon on July 03, 2012, 10:08:31 AM
Thankfully my physician does the prescribing, not the pharma company. Not so bad if my doc has more information than less.
:rolleyes: Corporations are teh evol, docs are teh wholesome and altruistic. Sure.
Remember Pfizer getting busted for this? Remember how much fallout there was from doctors that lost their medical licenses over improperly prescribing based on the perks they were getting from their drug reps?
You go to the doctor. He submits claims to your insurer, who are going to find any and every reason they can not to pay and stick the doctor with a tab on you that may or may not get settled when it goes to collections. The same doctor gets all kinds of comps from his drug reps; whose interests do you think the doc is going to favor?
Maybe you should get a better physician. I wouldn't go to a physician who didn't think helping me out was important and was willing to give me shitty drugs instead. :blink:
Quote from: Neil on July 03, 2012, 10:57:34 AM
Quote from: garbon on July 03, 2012, 10:08:31 AM
It is very relevant. Doesn't seem fair to convict someone of a crime they didn't commit. :huh:
They're still responsible. Being the boss is about more than the seven-figure salary and the private jet. We live in a wonderful time for removing the freedom of action from your subordinates via technology.
Responsible in a way that they should go to jail?
Quote from: garbon on July 03, 2012, 11:03:22 AM
Quote from: Neil on July 03, 2012, 10:57:34 AM
Quote from: garbon on July 03, 2012, 10:08:31 AM
It is very relevant. Doesn't seem fair to convict someone of a crime they didn't commit. :huh:
They're still responsible. Being the boss is about more than the seven-figure salary and the private jet. We live in a wonderful time for removing the freedom of action from your subordinates via technology.
Responsible in a way that they should go to jail?
Depending on the circumstances but it should not be excluded. Bosses can be held criminally responsible if they created an environment (e.g. by failing to implement supervision measures or failing to observe them) in which crime became systemic or unchecked.
Quote from: garbon on July 03, 2012, 11:02:50 AM
:rolleyes: Corporations are teh evol, docs are teh wholesome and altruistic. Sure.
Remember Pfizer getting busted for this? Remember how much fallout there was from doctors that lost their medical licenses over improperly prescribing based on the perks they were getting from their drug reps?
You go to the doctor. He submits claims to your insurer, who are going to find any and every reason they can not to pay and stick the doctor with a tab on you that may or may not get settled when it goes to collections. The same doctor gets all kinds of comps from his drug reps; whose interests do you think the doc is going to favor?
Maybe you should get a better physician. I wouldn't go to a physician who didn't think helping me out was important and was willing to give me shitty drugs instead. :blink:
[/quote]
I don't have a doctor I "go to." A) I can't afford it, and B) I don't trust anybody, let alone somebody who's going to be so far in debt from school that they're going to desperately need deep pockets to survive.
Quote from: Martinus on July 03, 2012, 11:21:21 AM
Depending on the circumstances but it should not be excluded. Bosses can be held criminally responsible if they created an environment (e.g. by failing to implement supervision measures or failing to observe them) in which crime became systemic or unchecked.
Certainly but then I don't see that discussed here. I just see pitchforks and torches.
Quote from: DontSayBanana on July 03, 2012, 11:26:14 AM
I don't have a doctor I "go to." A) I can't afford it, and B) I don't trust anybody, let alone somebody who's going to be so far in debt from school that they're going to desperately need deep pockets to survive.
I'm not really sure what you expect me to say.
Quote from: garbon on July 03, 2012, 11:03:22 AM
Quote from: Neil on July 03, 2012, 10:57:34 AM
Quote from: garbon on July 03, 2012, 10:08:31 AM
It is very relevant. Doesn't seem fair to convict someone of a crime they didn't commit. :huh:
They're still responsible. Being the boss is about more than the seven-figure salary and the private jet. We live in a wonderful time for removing the freedom of action from your subordinates via technology.
Responsible in a way that they should go to jail?
I think it would depend on the circumstances, but it's certainly a tool in the arsenal.
Quote from: garbon on July 03, 2012, 11:32:13 AM
I'm not really sure what you expect me to say.
*shrugs* I'm a little paranoid; I'm just surprised that you're showing to be the most trusting individual in this case.
That being said, in case of a wide-spread practice like that of GSK, I think the onus should be on the bosses to prove that this was a work of some rogue chemists and marketing people and not done with an approval of the management.
In any event, the issue is moot, since the entire corporation got an immunity from prosecution so whoever was responsible will certainly not face any criminal liability in the US.
Quote from: DontSayBanana on July 03, 2012, 11:35:09 AM
Quote from: garbon on July 03, 2012, 11:32:13 AM
I'm not really sure what you expect me to say.
*shrugs* I'm a little paranoid; I'm just surprised that you're showing to be the most trusting individual in this case.
Trusting? This isn't a trust issue here but more of a - really do I actually think that most doctors out there want to harm their patients? (Even if that harm just comes in the form of benign neglect and poor treatment plans.) Of course the news is replete with stories of doctors that got kickbacks and prescribed things they shouldn't have - that's what is exciting and "newsworthy". That says next to nothing about the actual incidence of "evil" docs.
Besides, I'm not saying that one than slavish follows the orders of one's doctor. Hell, shopping around is an important part of the process.
Quote from: Martinus on July 03, 2012, 11:39:40 AM
That being said, in case of a wide-spread practice like that of GSK, I think the onus should be on the bosses to prove that this was a work of some rogue chemists and marketing people and not done with an approval of the management.
You would like them to prove that they didn't tell their marketing people to do so? Short of showing that they have training programs in place to coach people not to promote off-label usages, how would you have them prove this negative proposition?
Quote from: garbon on July 03, 2012, 11:58:59 AM
Trusting? This isn't a trust issue here but more of a - really do I actually think that most doctors out there want to harm their patients? (Even if that harm just comes in the form of benign neglect and poor treatment plans.) Of course the news is replete with stories of doctors that got kickbacks and prescribed things they shouldn't have - that's what is exciting and "newsworthy". That says next to nothing about the actual incidence of "evil" docs.
Besides, I'm not saying that one than slavish follows the orders of one's doctor. Hell, shopping around is an important part of the process.
I'm not suggesting doctors are out to deliberately harm their patients- what I'm saying is that in a perfect world, a doctor's primary focus would be the patient's best interest, and they would defer judgment on prescribing for other than the approved use. In practice, at least a small amount of doctors have shown an "it couldn't hurt" attitude reinforced by drug reps egging them on and offering perks.
Quote from: garbon on July 03, 2012, 12:00:03 PM
You would like them to prove that they didn't tell their marketing people to do so? Short of showing that they have training programs in place to coach people not to promote off-label usages, how would you have them prove this negative proposition?
Yes, actually. When we're talking ultra-massive distribution of international household names like Wellbutrin or Avandia, so much of the company's going to be tied up in marketing that specific product that to believe the CEO isn't going to be looking over marketing's shoulder is, at best, naive.
We're not talking about a niche vaccine that's only being distributed to one affected area in isolation, where the team's just going to get a marketing plan rubber-stamped by the marketing department.
Quote from: garbon on July 03, 2012, 10:08:31 AM
Quote from: CountDeMoney on July 03, 2012, 09:58:47 AM
Who gives a fuck. Somebody needs to be held accountable. and sometimes they need to be prosecuted.
It is very relevant. Doesn't seem fair to convict someone of a crime they didn't commit. :huh:
Well, now that they paid their speeding ticket, we don't have to worry about anybody going to jail now for anything, now do we?
Quote from: CountDeMoney on July 03, 2012, 12:23:38 PM
Quote from: garbon on July 03, 2012, 10:08:31 AM
Quote from: CountDeMoney on July 03, 2012, 09:58:47 AM
Who gives a fuck. Somebody needs to be held accountable. and sometimes they need to be prosecuted.
It is very relevant. Doesn't seem fair to convict someone of a crime they didn't commit. :huh:
Well, now that they paid their speeding ticket, we don't have to worry about anybody going to jail now for anything, now do we?
Your comments in this thread didn't seem to be about just this case.
Quote from: DontSayBanana on July 03, 2012, 12:10:36 PM
Quote from: garbon on July 03, 2012, 11:58:59 AM
Trusting? This isn't a trust issue here but more of a - really do I actually think that most doctors out there want to harm their patients? (Even if that harm just comes in the form of benign neglect and poor treatment plans.) Of course the news is replete with stories of doctors that got kickbacks and prescribed things they shouldn't have - that's what is exciting and "newsworthy". That says next to nothing about the actual incidence of "evil" docs.
Besides, I'm not saying that one than slavish follows the orders of one's doctor. Hell, shopping around is an important part of the process.
I'm not suggesting doctors are out to deliberately harm their patients- what I'm saying is that in a perfect world, a doctor's primary focus would be the patient's best interest, and they would defer judgment on prescribing for other than the approved use. In practice, at least a small amount of doctors have shown an "it couldn't hurt" attitude reinforced by drug reps egging them on and offering perks.
Not sure why this is particularly relevant then if there are a small amount of doctors who are unethical. Nothing is ever ideal, so I'm not sure why that means we should treat healthcare providers as evil.
Quote from: DontSayBanana on July 03, 2012, 12:16:18 PM
Yes, actually. When we're talking ultra-massive distribution of international household names like Wellbutrin or Avandia, so much of the company's going to be tied up in marketing that specific product that to believe the CEO isn't going to be looking over marketing's shoulder is, at best, naive.
We're not talking about a niche vaccine that's only being distributed to one affected area in isolation, where the team's just going to get a marketing plan rubber-stamped by the marketing department.
I think it is a bit unfair to assume that the CEO is going to oversee all marketing/sales efforts. And especially given the no-no that is promoting off label usage, it seems a bit of a stretch to think that a CEO would approve such a plan.
But he's the CEO, if he's not responsible for that, what is he there for? Delegation doesn't free you of responsability.
Quote from: Grey Fox on July 03, 2012, 01:18:35 PM
But he's the CEO, if he's not responsible for that, what is he there for? Delegation doesn't free you of responsability.
The president doesn't go to jail every time the government is caught doing criminal shit. He has to get blowjobs for that.
Quote from: The Brain on July 03, 2012, 01:21:18 PM
Quote from: Grey Fox on July 03, 2012, 01:18:35 PM
But he's the CEO, if he's not responsible for that, what is he there for? Delegation doesn't free you of responsability.
The president doesn't go to jail every time the government is caught doing criminal shit. He has to get blowjobs for that.
Maybe he should :hmm: However criminal & civil laws aren't the same thing.
Quote from: DontSayBanana on July 03, 2012, 11:35:09 AM
*shrugs* I'm a little paranoid;
There are pills for that. Well, they're for something else, but insurance will cover it anyway.
Quote from: DGuller on July 03, 2012, 01:30:45 PM
Quote from: DontSayBanana on July 03, 2012, 11:35:09 AM
*shrugs* I'm a little paranoid;
There are pills for that. Well, they're for something else, but insurance will cover it anyway.
He can't afford a doctor.
Quote from: The Brain on July 03, 2012, 01:21:18 PM
The president doesn't go to jail every time the government is caught doing criminal shit. He has to get blowjobs for that.
Quote from: garbon on July 02, 2012, 11:55:29 PM
Quote from: Capetan Mihali on July 02, 2012, 11:41:41 PM
What's wrong with Wellbutrin?
While it's a common intro drug - it can also have some jarring side effects...especially the withdrawal!
Wellbutrin picked my ass up off the ground. I'm maxed out on it, and the only side effect for me was dry mouth in the beginning.
Withdrawing from Celexa, however, was miserable.
Quote from: Capetan Mihali on July 03, 2012, 05:55:03 PM
Wellbutrin picked my ass up off the ground. I'm maxed out on it, and the only side effect for me was dry mouth in the beginning.
Withdrawing from Celexa, however, was miserable.
I tapped in real quick to Wellbutrin's side effect of increased agitation. The littlest things pissed me off for hours on end. When coming off it - and I think I only took it about a month - I had awful headaches/spells of dizziness.
I don't really recall much in the way of withdrawal from Lexapro, which I demanded over Celexa. :D
Quote from: garbon on July 03, 2012, 12:53:54 PM
Quote from: DontSayBanana on July 03, 2012, 12:16:18 PM
Yes, actually. When we're talking ultra-massive distribution of international household names like Wellbutrin or Avandia, so much of the company's going to be tied up in marketing that specific product that to believe the CEO isn't going to be looking over marketing's shoulder is, at best, naive.
We're not talking about a niche vaccine that's only being distributed to one affected area in isolation, where the team's just going to get a marketing plan rubber-stamped by the marketing department.
I think it is a bit unfair to assume that the CEO is going to oversee all marketing/sales efforts. And especially given the no-no that is promoting off label usage, it seems a bit of a stretch to think that a CEO would approve such a plan.
Okay, then perhaps we should just arrest people in marketing. Or Marketing Research or whatever.
Quote from: Razgovory on July 03, 2012, 08:41:07 PM
Okay, then perhaps we should just arrest people in marketing. Or Marketing Research or whatever.
Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.
Got a question about this part:
QuotePaxil was illegally promoted to patients under 18 when the drug wasn't approved for this age group
Now, my understanding was that once the FDA approves a drug, doctors aren't restricted to prescribing it for a certain purpose or to a certain group of patients. For example, a few years ago when the FDA was being asked to approve Thalidomine as a medicine to help people undergoing chemo or radiation therapy from being constantly nauseated, there were fears that if it were approved, some doctors would stupidly prescribe it to pregnant women to combat morning sickness (which was what it was originally developed to do). So if doctors could legally prescribe Paxil to patients under 18 (even if it wasn't specifically approved for them) what's the problem?
Quote from: dps on July 03, 2012, 09:13:51 PM
Got a question about this part:
QuotePaxil was illegally promoted to patients under 18 when the drug wasn't approved for this age group
Now, my understanding was that once the FDA approves a drug, doctors aren't restricted to prescribing it for a certain purpose or to a certain group of patients. For example, a few years ago when the FDA was being asked to approve Thalidomine as a medicine to help people undergoing chemo or radiation therapy from being constantly nauseated, there were fears that if it were approved, some doctors would stupidly prescribe it to pregnant women to combat morning sickness (which was what it was originally developed to do). So if doctors could legally prescribe Paxil to patients under 18 (even if it wasn't specifically approved for them) what's the problem?
Issue is the promotion by GSK for use in patients under 18. Drug companies can only market to the indications that the FDA has approved not simply whatever patients the drug company might think it appropriate for. If the FDA doesn't grant you a juvenile indication then you can't go out and tell doctors to prescribe it for their patients under 18. Doctors, of course, are totally still able to do so, they just can't receive information about doing so from big pharma.
Quote from: garbon on July 03, 2012, 09:17:13 PM
Quote from: dps on July 03, 2012, 09:13:51 PM
Got a question about this part:
QuotePaxil was illegally promoted to patients under 18 when the drug wasn’t approved for this age group
Now, my understanding was that once the FDA approves a drug, doctors aren't restricted to prescribing it for a certain purpose or to a certain group of patients. For example, a few years ago when the FDA was being asked to approve Thalidomine as a medicine to help people undergoing chemo or radiation therapy from being constantly nauseated, there were fears that if it were approved, some doctors would stupidly prescribe it to pregnant women to combat morning sickness (which was what it was originally developed to do). So if doctors could legally prescribe Paxil to patients under 18 (even if it wasn't specifically approved for them) what's the problem?
Issue is the promotion by GSK for use in patients under 18. Drug companies can only market to the indications that the FDA has approved not simply whatever patients the drug company might think it appropriate for. If the FDA doesn't grant you a juvenile indication then you can't go out and tell doctors to prescribe it for their patients under 18. Doctors, of course, are totally still able to do so, they just can't receive information about doing so from big pharma.
Is there not a free speach issue there?
Quote from: dps on July 03, 2012, 09:21:44 PM
Is there not a free speach issue there?
I'm not a lawtalker so I don't know but I'd guess concerns about undue influence from pharmaceuticals (potentially in ways that actually harm patients - although pharmas would lose in the long run if they promote harmful off-label usages) has been found to be a trumping issue.
Quote from: garbon on July 03, 2012, 09:30:15 PM
I'm not a lawtalker so I don't know but I'd guess concerns about undue influence from pharmaceuticals (potentially in ways that actually harm patients - although pharmas would lose in the long run if they promote harmful off-label usages) has been found to be a trumping issue.
Prescription drugs are on most, if not all, states' schedules of restricted substances- since possessing a prescription drug without a valid prescription is a misdemeanor at least, the state has an interest in controlling distribution of those substances.
Quote from: DontSayBanana on July 03, 2012, 09:41:24 PM
Quote from: garbon on July 03, 2012, 09:30:15 PM
I'm not a lawtalker so I don't know but I'd guess concerns about undue influence from pharmaceuticals (potentially in ways that actually harm patients - although pharmas would lose in the long run if they promote harmful off-label usages) has been found to be a trumping issue.
Prescription drugs are on most, if not all, states' schedules of restricted substances- since possessing a prescription drug without a valid prescription is a misdemeanor at least, the state has an interest in controlling distribution of those substances.
Except that as dps helped point out, docs aren't prevented from prescribing for off-label usages as long as they can get insurance approval or patient doesn't care about such.
Quote from: garbon on July 03, 2012, 09:46:41 PM
Except that as dps helped point out, docs aren't prevented from prescribing for off-label usages as long as they can get insurance approval or patient doesn't care about such.
As long as it's got a rational basis. Good luck defending a scrip for antidepressants to treat an infection in a malpractice suit.
Quote from: DontSayBanana on July 03, 2012, 09:52:18 PM
Quote from: garbon on July 03, 2012, 09:46:41 PM
Except that as dps helped point out, docs aren't prevented from prescribing for off-label usages as long as they can get insurance approval or patient doesn't care about such.
As long as it's got a rational basis. Good luck defending a scrip for antidepressants to treat an infection in a malpractice suit.
Of course, off-label usages promoted by pharma companies generally aren't like that...as again, you don't make a profit in the long run if people don't actually want to keep using the drug for said use. ;)
Quote from: dps on July 03, 2012, 09:21:44 PM
Is there not a free speach issue there?
Commercial speech historically has been less protected than other forms of speech. There are all kinds of regulations specifically regarding pharmaceuticals- for instance banning advertising of investigational products, bans of direct to consumer ads for Schedule II drugs, drugs with "black box" warnings, etc.
However, recently the Supreme Court has began to protect commercial speech more and more. In fact, the Court has decided several First Amendment cases relating to pharmaceuticals- one case held that regulations limiting pharmacy advertisements of compounding services was unconstitutional and another case held that a law forbidding data mining of patient prescriptions was unconstitutional. I took a class on the law of medical technology this past semester and the professor predicted that a lot of these regulations could potentially be challenged based on how the Court has been going.
In this thread I learned: Al Capone's liability = Corporate CEO liability. :P
Quote from: Tonitrus on July 03, 2012, 10:34:55 PM
In this thread I learned: Al Capone's liability = Corporate CEO liability. :P
They'd never get a corporate CEO for tax evasion these days. Their liars are too good for that.
Quote from: dps on July 03, 2012, 09:21:44 PM
Quote from: garbon on July 03, 2012, 09:17:13 PM
Quote from: dps on July 03, 2012, 09:13:51 PM
Got a question about this part:
QuotePaxil was illegally promoted to patients under 18 when the drug wasn't approved for this age group
Now, my understanding was that once the FDA approves a drug, doctors aren't restricted to prescribing it for a certain purpose or to a certain group of patients. For example, a few years ago when the FDA was being asked to approve Thalidomine as a medicine to help people undergoing chemo or radiation therapy from being constantly nauseated, there were fears that if it were approved, some doctors would stupidly prescribe it to pregnant women to combat morning sickness (which was what it was originally developed to do). So if doctors could legally prescribe Paxil to patients under 18 (even if it wasn't specifically approved for them) what's the problem?
Issue is the promotion by GSK for use in patients under 18. Drug companies can only market to the indications that the FDA has approved not simply whatever patients the drug company might think it appropriate for. If the FDA doesn't grant you a juvenile indication then you can't go out and tell doctors to prescribe it for their patients under 18. Doctors, of course, are totally still able to do so, they just can't receive information about doing so from big pharma.
Is there not a free speach issue there?
Commercial speech may be regulated in ways that political and artistic speech cannot.
In this case, it could either fall under deceptive speech (unprotected entirely) or, if that didn't fly, they could still uphold such regulation under Central Hudson's test, simply requiring the restriction to advance an important government interest (check) and that it be no broader than necessary (arguable, but I'll say check).
Quote from: stjaba on July 03, 2012, 10:17:10 PM
Quote from: dps on July 03, 2012, 09:21:44 PM
Is there not a free speach issue there?
Commercial speech historically has been less protected than other forms of speech. There are all kinds of regulations specifically regarding pharmaceuticals- for instance banning advertising of investigational products, bans of direct to consumer ads for Schedule II drugs, drugs with "black box" warnings, etc.
However, recently the Supreme Court has began to protect commercial speech more and more. In fact, the Court has decided several First Amendment cases relating to pharmaceuticals- one case held that regulations limiting pharmacy advertisements of compounding services was unconstitutional and another case held that a law forbidding data mining of patient prescriptions was unconstitutional. I took a class on the law of medical technology this past semester and the professor predicted that a lot of these regulations could potentially be challenged based on how the Court has been going.
I wonder if the Coyote Publishing case ever got to the Ninth en banc. Nevada's brothel advertising restrictions are ripe to be struck down.
Quote from: Ideologue on July 04, 2012, 12:17:20 AM
In this case, it could either fall under deceptive speech (unprotected entirely) or, if that didn't fly, they could still uphold such regulation under Central Hudson's test, simply requiring the restriction to advance an important government interest (check) and that it be no broader than necessary (arguable, but I'll say check).
Regarding restrictions on advertising of pharmaceutical products, my prof's argument was that in recent cases the Supreme Court has broadly construed the no broader than necessary test, and that the Court's current preferred approach is to not restrict speech, but rather to require additional disclosures or go through non-speech alternatives, if there is no potentially misleading/false speech.
I am basing this off my class notes from early February, so I might be missing a nuance. Now that I'm going through bar review and covering the First Amendment in depth for the first time, I get the sense he might be overreacting, but who really knows.
I haven't looked at cases directly applicable to pharma issues. The last time I really looked in depth into it was for writing a paper on Coyote Publishing, involving brothel advertising.
In general they've really been moving toward the protection of commercial speech, though; I'd agree with your prof on that.
Quote from: garbon on July 03, 2012, 09:06:46 PM
Quote from: Razgovory on July 03, 2012, 08:41:07 PM
Okay, then perhaps we should just arrest people in marketing. Or Marketing Research or whatever.
Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.
The knowledge that you are breaking the law is not necessary to be criminally liable.
Quote from: Martinus on July 04, 2012, 01:19:42 AM
Quote from: garbon on July 03, 2012, 09:06:46 PM
Quote from: Razgovory on July 03, 2012, 08:41:07 PM
Okay, then perhaps we should just arrest people in marketing. Or Marketing Research or whatever.
Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.
The knowledge that you are breaking the law is not necessary to be criminally liable.
Market researchers are more than trained on what is permissible and not. If they break applicable laws, I'd say throw the book at them. :menace:
Quote from: DontSayBanana on July 03, 2012, 09:41:24 PM
Quote from: garbon on July 03, 2012, 09:30:15 PM
I'm not a lawtalker so I don't know but I'd guess concerns about undue influence from pharmaceuticals (potentially in ways that actually harm patients - although pharmas would lose in the long run if they promote harmful off-label usages) has been found to be a trumping issue.
Prescription drugs are on most, if not all, states' schedules of restricted substances- since possessing a prescription drug without a valid prescription is a misdemeanor at least, the state has an interest in controlling distribution of those substances.
Antidepressants and antibiotics are Rx-only, but they aren't scheduled.
Quote from: Martinus on July 04, 2012, 01:19:42 AM
Quote from: garbon on July 03, 2012, 09:06:46 PM
Quote from: Razgovory on July 03, 2012, 08:41:07 PM
Okay, then perhaps we should just arrest people in marketing. Or Marketing Research or whatever.
Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.
The knowledge that you are breaking the law is not necessary to be criminally liable.
Ignorance of the law is not a defense, but ignorance of fact is.
Quote from: dps on July 04, 2012, 04:01:45 AM
Quote from: Martinus on July 04, 2012, 01:19:42 AM
Quote from: garbon on July 03, 2012, 09:06:46 PM
Quote from: Razgovory on July 03, 2012, 08:41:07 PM
Okay, then perhaps we should just arrest people in marketing. Or Marketing Research or whatever.
Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.
The knowledge that you are breaking the law is not necessary to be criminally liable.
Ignorance of the law is not a defense, but ignorance of fact is.
Ignorance of fact *may* be a defense but does not have to be. It's only a defense if the ignorance is justified (so is not a result of negligence for example).
As garbon has pointed out, the issue is that phyiscians are not restricted by law as to what they can prescribe drugs for - in that they can prescribe "off label" (leaving aside liability concens). On the other hand, manufacturers cannot "promote" drugs for off-label uses. Yet it takes years and millions of dollars for manufacturers to have a drug indication approved.
This creates an obvious incentive, when a hot new use for a drug is discovered, to promote "off label" to physicians.
The lines are not at all clear-cut, as some types of "off label" promotion to docs is not only allowed, but is required. For example, in order to get a new indication, manufacturers must do clinical testing, which requires recruiting docs and patients for clinical trials ... to generate scientific debate about drugs, it is necessary to hold scientific conferences ... all of which can potentially be used (or abused) to promote "off label" to physicians. Hence a proliferation of rules concering these activities (not nearly as elaborate in Canada as in the US, btw).
Quote from: Martinus on July 04, 2012, 04:17:39 AM
Quote from: dps on July 04, 2012, 04:01:45 AM
Quote from: Martinus on July 04, 2012, 01:19:42 AM
Quote from: garbon on July 03, 2012, 09:06:46 PM
Quote from: Razgovory on July 03, 2012, 08:41:07 PM
Okay, then perhaps we should just arrest people in marketing. Or Marketing Research or whatever.
Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.
The knowledge that you are breaking the law is not necessary to be criminally liable.
Ignorance of the law is not a defense, but ignorance of fact is.
Ignorance of fact *may* be a defense but does not have to be. It's only a defense if the ignorance is justified (so is not a result of negligence for example).
Yes, it's not an absolute defense.
Quote from: dps on July 04, 2012, 12:49:46 PM
Yes, it's not an absolute defense.
"Ignorance of fact" is not only not an absolute defence, it really can't be characterized as a defence at all. It depends entirely on the situation. You can be convicted of stealing property that turned out to be your own, if you intended to steal someone else's property. Or you can be acquitted of stealing property if you had reasonable grounds to believe it was already your own.