GlaxoSmithKline to pay $3 billion for health fraud

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http://www.sfgate.com/news/article/G...ud-3678945.php

WASHINGTON (AP) — GlaxoSmithKline LLC will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement in U.S. history, the Justice Department said Monday.

The $3 billion fine also will be the largest penalty ever paid by a drug company, Deputy Attorney General James M. Cole said. The corporation also agreed to be monitored by government officials for five years to attempt to ensure the company's compliance, Cole said..........

It really sounds very stupid that such a successful drug company could allow what they did.

Originally Posted by fcit

http://www.sfgate.com/news/article/G...ud-3678945.php

WASHINGTON (AP) — GlaxoSmithKline LLC will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement in U.S. history, the Justice Department said Monday.

The $3 billion fine also will be the largest penalty ever paid by a drug company, Deputy Attorney General James M. Cole said. The corporation also agreed to be monitored by government officials for five years to attempt to ensure the company's compliance, Cole said..........

Looks like its the end of free drug company vacations

nm

From the article:

"For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business," Acting Assistant Attorney General Stuart F. Delery, head of Justice's civil division, said at the news conference. "That is why this administration is committed to using every available tool to defeat health care fraud."

I wonder how they came up with the $3 billion figure? Because, while a large fine indeed, all those drugs over all those years certainly made GSK more than $3 billion. So it would seem this settlement is just a cost of doing business after all.

Originally Posted by Abdi509

It really sounds very stupid that such a successful drug company could allow what they did.

What blows my mind is they can shrug off a $3 billion dollar fine. Does this mean that buproprion is actually not helpful in smoking cessation, or are they referring to other substances?

Yeah, I was thinking that too. Anyone care to answer that?

"CEO Andrew Witty expressed regret and said that they have learned 'from the mistakes that were made.' "


Hahahahahaha.

Originally Posted by mmmcdowe

What blows my mind is they can shrug off a $3 billion dollar fine. Does this mean that buproprion is actually not helpful in smoking cessation, or are they referring to other substances?

For this fine in particular, I don't think that it means that any of those off label uses WEREN'T effective. It just means that they were never approved for the off label uses, whether they actually worked or not.

Originally Posted by CaptainSSO

"CEO Andrew Witty expressed regret and said that they have learned 'from the mistakes that were made.' ".

...after which he offered the prosecuting attorney a job with GSK for a handsome salary to keep that revolving door going....

Originally Posted by Rothbard

Bro, they're successful precisely because they do this sort of thing. We just never hear about most of their fraudulent activity. Many of the drugs we use are pretty much worthless, or the risk benefit ratio sits right at 1:1, or they're straight up harmful.

I dont know about that, competition is pretty quick to figure out if a drug is worthless...there is more than one drug company competing against each other remember.

What the government is calling "fraud" seems to be "off-label use of a drug". I don't think there is any allegation that GSK said a particular drug was FDA-approved for a purpose when it wasn't. So what's wrong with giving physicians data on their drugs and letting physicians and patients decide if they want to try a drug for off-label purposes?

Originally Posted by Rothbard

Bro, they're successful precisely because they do this sort of thing. We just never hear about most of their fraudulent activity. Many of the drugs we use are pretty much worthless, or the risk benefit ratio sits right at 1:1, or they're straight up harmful.

Mistakes do happen in drug development but covering up the mistakes is unacceptable.

Blair Hamrick was one of the GlaxoSmithKline whistle-blowers whose firsthand revelations about off-label prescription drug marketing helped lead to the historic $3 billion settlement announced Monday... Of the $3 billion settlement, $1.04 billion in civil fines is connected to Hamrick's case, according to his attorneys. Whistle-blowers in similar cases often receive 15 to 25 percent of the civil fine.
http://www.tampabay.com/news/busines...s-lips/1238388

Originally Posted by Dr Love

What the government is calling "fraud" seems to be "off-label use of a drug". I don't think there is any allegation that GSK said a particular drug was FDA-approved for a purpose when it wasn't. So what's wrong with giving physicians data on their drugs and letting physicians and patients decide if they want to try a drug for off-label purposes?

Physicians are allowed to use a drug for "off-label" purposes. Pharma companies are not allowed to promote a drug for "off-label" purposes because it was never approved for those purposes in the first place. The difference is that physicians are supposed to use clinical judgement to decide whether to give it for off label purposes on a case by case basis, not just give it to anyone with a condition because a pharma company paid for their vacation. Plus I don't call giving physicians a million bucks to speak at conferences and vacations to Hawaii "giving data on drugs".

Originally Posted by Dr Love

What the government is calling "fraud" seems to be "off-label use of a drug". I don't think there is any allegation that GSK said a particular drug was FDA-approved for a purpose when it wasn't. So what's wrong with giving physicians data on their drugs and letting physicians and patients decide if they want to try a drug for off-label purposes?

Patients can decide that, but pharma companies can't promote their sleeping aid as a cure for cancer.

Naughty Dr. Drew:
http://gawker.com/5923057/prosecutor...ium=socialflow

Originally Posted by Rothbard

Bro, they're successful precisely because they do this sort of thing. We just never hear about most of their fraudulent activity. Many of the drugs we use are pretty much worthless, or the risk benefit ratio sits right at 1:1, or they're straight up harmful.

I just absolutely love how clearly unverifiable this claim is like all good conspiracy theories, "If we know this, just think of all the things we DONT know, maaaaaaannnnnnnn" (the "man" was intended to be read in the voice of Cheech Marin)

And then there is the unsubstantiated extrapolation that since we dont know xxxx, that obviously many of the drugs are worthless, and then is is totally appropriate to just label them as harmful since "close enough, right?". You don't even seem aware that you are basically rounding 3 up to 10....... "Well, 3 is basically 5 if we want to keep the units easy, and 5 easily rounds to 10, so yes, my junk is not 3 inches long, it is 10" You're doing the exact same thing every time you talk about the harm with drugs. Fact: most of the drugs we use are safe and do far more good than harm. Fact: all drugs have capacity for harm since the drugs we use are actually effective. Fact: the drugs that have zero harm also have zero efficacy.

That said, it is absolutely inappropriate for a drug company to market (and promoting data is in fact marketing, as defined) a drug for off label use. This is not evidence of the reckless nature of modern medicine, this is evidence of the system working to protect the patient and I can come up with 3 billion reasons as to why

Originally Posted by facetguy

Naughty Dr. Drew:
http://gawker.com/5923057/prosecutor...ium=socialflow

that dude is a hack and a sell-out. It doesnt surprise me at all that the TV docs are paid to promote the snake oil and miracle cures. (This next part is not directed at you, btw.... but its hard to make the point without potentially having it received that way ) Ironically it is the alternative therapies that very often do the least amount of real work to ensure their therapies are safe and, except for the low level of efficacy that I brought up in my last post, would be doing the most harm to patients.

Originally Posted by facetguy

Naughty Dr. Drew:
http://gawker.com/5923057/prosecutor...ium=socialflow

When is the secret of Kevin Spacey and Chevy Chase's conception going to come out in nature?

Originally Posted by Rothbard

Many of the drugs we use are pretty much worthless, or the risk benefit ratio sits right at 1:1, or they're straight up harmful.

And the efficacy of "successful" drugs is sometimes manufactured.

Originally Posted by Dr Love

What the government is calling "fraud" seems to be "off-label use of a drug". I don't think there is any allegation that GSK said a particular drug was FDA-approved for a purpose when it wasn't. So what's wrong with giving physicians data on their drugs and letting physicians and patients decide if they want to try a drug for off-label purposes?

The issue was GSK's promotion of the off-label use, which is not allowed.

Originally Posted by Freddie Mercury

The issue was GSK's promotion of the off-label use, which is not allowed.

From an uniformed pre-med, how are off-label beneficial actions discovered if not for the drug companies letting people know?

They're discovered by studying its effects and publishing the results and getting them approved. Thereby becoming not 'off label' anymore. Off label by definition means unproved so there is no evidence that the effects are beneficial - it's simply the drug companies claiming they are.

Originally Posted by Lokhtar

They're discovered by studying its effects and publishing the results and getting them approved. Thereby becoming not 'off label' anymore. Off label by definition means unproved so there is no evidence that the effects are beneficial - it's simply the drug companies claiming they are.

Fair enough, thanks!

Originally Posted by Lokhtar

They're discovered by studying its effects and publishing the results and getting them approved. Thereby becoming not 'off label' anymore. Off label by definition means unproved so there is no evidence that the effects are beneficial - it's simply the drug companies claiming they are.

Not quite... in fact, I would hope the physician chose to use the drug 'off label' precisely because there was considerable evidence that the effects will be beneficial. "Off label" means that you are using the drug not in accordance with what is listed on the label. Drug labels list the specific conditions the drug is FDA approved for the treatment of.

For example, drug X may be indicated for the treatment of patients with lung cancer who have a mutation in gene AAA. This will specifically be indicated on the label. However, suppose a patient with pharynx cancer fails all standard therapy, but appears to have a mutation in gene AAA. The physician may decide to give this patient drug X, but this will be 'off label' since drug X is not FDA-approved for pharynx cancer. There actually may be tremendous amounts of published evidence and even case studies pointing towards the therapeutic potential of drug X in pharyngeal cancer patients; the only thing presently lacking is FDA-approval.

Originally Posted by Lokhtar

They're discovered by studying its effects and publishing the results and getting them approved. Thereby becoming not 'off label' anymore. Off label by definition means unproved so there is no evidence that the effects are beneficial - it's simply the drug companies claiming they are.

That is not true. It doesn't mean there is no evidence. The definition of off label means the FDA hasn't approved those usages yet.

Many times either the drug company or other research body publish evidence of efficacy in other diseases but there is really little benefit for the drug company to pay large sums of money to reapply to the FDA.

There are actually quite a few "off-label" usages which are commonplace and strongly supported by tons of research.

Originally Posted by link2swim06

That is not true. It doesn't mean there is no evidence. The definition of off label means the FDA hasn't approved those usages yet.

Many times either the drug company or other research body publish evidence of efficacy in other diseases but there is really little benefit for the drug company to pay large sums of money to reapply to the FDA.

There are actually quite a few "off-label" usages which are commonplace and strongly supported by tons of research.

Or clinicians publish data on unexpected (beneficial) effects of the drug which prompt a full trial to get approval

Originally Posted by Freddie Mercury

Not quite... in fact, I would hope the physician chose to use the drug 'off label' precisely because there was considerable evidence that the effects will be beneficial. "Off label" means that you are using the drug not in accordance with what is listed on the label. Drug labels list the specific conditions the drug is FDA approved for the treatment of.

For example, drug X may be indicated for the treatment of patients with lung cancer who have a mutation in gene AAA. This will specifically be indicated on the label. However, suppose a patient with pharynx cancer fails all standard therapy, but appears to have a mutation in gene AAA. The physician may decide to give this patient drug X, but this will be 'off label' since drug X is not FDA-approved for pharynx cancer. There actually may be tremendous amounts of published evidence and even case studies pointing towards the therapeutic potential of drug X in pharyngeal cancer patients; the only thing presently lacking is FDA-approval.

Right right I think what needs to really be emphasized here is that it was necessarily NOT the off-label useage that was incorrect. Many of these drugs are actually pretty well known by now to have some beneficial off-label uses. It's the fact that GSK was basically paying off physicians to prescribe the drug off-label that was the problem.

Originally Posted by calvnandhobbs68

Right right I think what needs to really be emphasized here is that it was NOT the off-label useage that was incorrect. Many of these drugs are actually pretty well known by now to have some beneficial off-label uses. It's the fact that GSK was basically paying off physicians to prescribe the drug off-label that was the problem.

Its hard to get people to not think, "its poison!!!! " whenever a drug company is in trouble. They are in trouble with or without negative outcomes. Off label prescription is common. Off label promotion by the drug co is illegal. Totally different ball games here

http://www.forbes.com/sites/robwater...iness-expense/
GlaxoSmithKline's $3 Billion Hit: Deterrent or Business Expense?

"So will the penalties imposed on GSK really deter nefarious behavior in the future? Baum agreed with his former client, Angela Reich, that while the fine itself is serious money, it doesn’t compare to the revenue the company made from fraudulent marketing. “The public exposure of the conduct may be more of a deterrent than the fines,” Baum said."

“If pharma companies can flout the law and then simply write a check when they get caught, they’re never going to stop,” said Sean Tracey. “The money is too large. Until and unless someone’s liberty comes to jeopardy, they simply consider this the cost of doing business.”

Maybe some jail time would hit home a little more than a fine.

Originally Posted by SpecterGT260

Its hard to get people to not think, "its poison!!!! " whenever a drug company is in trouble. They are in trouble with or without negative outcomes. Off label prescription is common. Off label promotion by the drug co is illegal. Totally different ball games here

In this case it does appear there were many negative effects.

The article facet guy posted below explains how they were promoting Paxil for teens (which was off-label, and apparently increased the prevalence of suicide) and withholding CV risk for Avandia.

Edit: Plus Advair for patients with mild asthma, which supposedly wasn't the proper treatment choice.

So to refute calvinhobess point I would say the off-label use WAS incorrect, although that might not be specifically what they were sued for.

Originally Posted by CaptainSSO

In this case it does appear there were many negative effects.

The article facet guy posted below explains how they were promoting Paxil for teens (which was off-label, and apparently increased the prevalence of suicide) and withholding CV risk for Avandia.

Edit: Plus Advair for patients with mild asthma, which supposedly wasn't the proper treatment choice.

So to refute calvinhobess point I would say the off-label use WAS incorrect, although that might not be specifically what they were sued for.

I am actually pretty confused as to how these examples contradict my statements. I was talking legalities only. Any negative effects found are probably real and noteworthy, but the point stands that people associate "wrong doing" with "dey killt mah baybay!" irregardless (somewhat surprised google didnt mark that as misspelled) of any actual harmful effect

Originally Posted by SpecterGT260

I am actually pretty confused as to how these examples contradict my statements. I was talking legalities only. Any negative effects found are probably real and noteworthy, but the point stands that people associate "wrong doing" with "dey killt mah baybay!" irregardless (somewhat surprised google didnt mark that as misspelled) of any actual harmful effect

Well the post you quoted said "the off-label usage was not incorrect," which was more of what I was addressing rather than any legalities.

But to address your point as to people's typical perceptions, I think in the case of pharmaceutical companies, in my opinion they definitely don't need any apologists. For Big Pharma I think it's always better to be skeptical of them rather than give them the benefit of the doubt.

Irregardless. What were you somewhat surprised at.

Originally Posted by CaptainSSO

Well the post you quoted said "the off-label usage was not incorrect," which was more of what I was addressing rather than any legalities.

But to address your point as to people's typical perceptions, I think in the case of pharmaceutical companies, in my opinion they definitely don't need any apologists. For Big Pharma I think it's always better to be skeptical of them rather than give them the benefit of the doubt.

Irregardless. What were you somewhat surprised at.

are you sure about that? here is what i said:

Originally Posted by SpecterGT260

Its hard to get people to not think, "its poison!!!! " whenever a drug company is in trouble. They are in trouble with or without negative outcomes. Off label prescription is common. Off label promotion by the drug co is illegal. Totally different ball games here

I was speaking about societal reaction without ANY notion of benefit or harm.

"irrelevant".... you need to understand this word

also, did you mean to quote calvin instead? your statement and its subsequent defense would make better sense....


EDIT: wait! re-read... "the post you quoted" i read as "in your post"... gimme a break, its friday night and my GF defended comps tonight so we are celebrating

irregardless.... My post had nothing to do with whether or not the harm or the benefit was real and everythign to do with the fact that if Joe Schmoe Amercian hears that Pfizer is in trouble he automatically assumes that they pushed a drug that "Kilt mah baybay"

I also DO NOT give pharma the benefit of the doubt honestly I dont give many people that at all. Its been problematic since the GF's dad is in dev for pfizer

on the one hand, it's sort of funny when drugs have multiple very beneficial off-label uses, and drug companies are legally not allowed to acknowledge or promote them. on the other, i think it's correct that physician experience and clinical trials (and not the opinion of the company that makes a drug) should determine what a medication is good for.

often, fda approvals are somewhat arbitrary and based upon what was done in the clinical trials. so, if a trial didn't include kids under 6, then the drug isn't approved for kids under 6. if a trial administered the medication in the doctor's office, then the med is only approved for administration in the doctor's office.

Originally Posted by SpecterGT260

I am actually pretty confused as to how these examples contradict my statements. I was talking legalities only. Any negative effects found are probably real and noteworthy, but the point stands that people associate "wrong doing" with "dey killt mah baybay!" irregardless (somewhat surprised google didnt mark that as misspelled) of any actual harmful effect

I've told you before that you sound like a Big Pharma attorney sometimes.

Originally Posted by facetguy

I've told you before that you sound like a Big Pharma attorney sometimes.

Yes you have. However, I actually sound like someone who is being indiscriminately critical. Your own biases are what lead you to conclude what was in your statement

Originally Posted by CaptainSSO

In this case it does appear there were many negative effects.

The article facet guy posted below explains how they were promoting Paxil for teens (which was off-label, and apparently increased the prevalence of suicide) and withholding CV risk for Avandia.

Edit: Plus Advair for patients with mild asthma, which supposedly wasn't the proper treatment choice.

So to refute calvinhobess point I would say the off-label use WAS incorrect, although that might not be specifically what they were sued for.

I'm not going through all the drugs just to make the point that some of the off label uses could be legit. Here's one example: Bupropion is only approved as an antidepressant but multiple studies have shown that it's effective for smoking cessation.

http://onlinelibrary.wiley.com/doi/1...BC1F3B1.d02t02

http://www.biomedcentral.com/1471-2458/6/300

Yes some of the off-label uses were probably not supported by anything but some also have legit off-label uses. That's neither here nor there because THATS NOT THE POINT OF THE FINE. Physicians are allowed to prescribe off-label. The point of physicians being able to do this is so when new studies come out showing a drug works for something they don't have to wait for a new FDA submission by the drug company to prescribe it.

Drug companies are not allowed to promote off-label. The end. Whether it works or not doesn't really matter from this standpoint. I'm sure quite a few of these off-label uses did have many negative side effects considering GSK was basically bribing physicians to prescribe them without looking at the evidence for or against off-label usage. My point was that fine did not necessarily equal incorrect usage even though it may have. I think SpecterGT260 and I are both speaking from a legal standpoint here and you didn't quite catch that. Apologies for not clarifying that in the first post but I figured this thread was about why they received the fine.

You're also confusing different points. The increased CV risk for Avandia is a side effect of the drug. Promoting it for patients with mild asthma is an off label use. Withholding side effects and promoting off-label use are two different things.

Edit: Another example, Zofran has four listed off-label uses currently being investigated (neuropsychiatric disorders, substance use, IBS, and post anesthetic shivering). Just because an article throws out a few examples of kids taking anti-depressants and comitting suicide (which is really a known side effect of anti-depressants anyway) doesn't mean that other off-label uses are wrong.

I just hope their new drug, Paracetamoxyfrusebendroneomycin, is a success.

Originally Posted by calvnandhobbs68

I'm not going through all the drugs just to make the point that some of the off label uses could be legit. Here's one example: Bupropion is only approved as an antidepressant but multiple studies have shown that it's effective for smoking cessation.

http://onlinelibrary.wiley.com/doi/1...BC1F3B1.d02t02

http://www.biomedcentral.com/1471-2458/6/300

Yes some of the off-label uses were probably not supported by anything but some also have legit off-label uses. That's neither here nor there because THATS NOT THE POINT OF THE FINE. Physicians are allowed to prescribe off-label. The point of physicians being able to do this is so when new studies come out showing a drug works for something they don't have to wait for a new FDA submission by the drug company to prescribe it.

Drug companies are not allowed to promote off-label. The end. Whether it works or not doesn't really matter from this standpoint. I'm sure quite a few of these off-label uses did have many negative side effects considering GSK was basically bribing physicians to prescribe them without looking at the evidence for or against off-label usage. My point was that fine did not necessarily equal incorrect usage even though it may have. I think SpecterGT260 and I are both speaking from a legal standpoint here and you didn't quite catch that. Apologies for not clarifying that in the first post but I figured this thread was about why they received the fine.

You're also confusing different points. The increased CV risk for Avandia is a side effect of the drug. Promoting it for patients with mild asthma is an off label use. Withholding side effects and promoting off-label use are two different things.

Edit: Another example, Zofran has four listed off-label uses currently being investigated (neuropsychiatric disorders, substance use, IBS, and post anesthetic shivering). Just because an article throws out a few examples of kids taking anti-depressants and comitting suicide (which is really a known side effect of anti-depressants anyway) doesn't mean that other off-label uses are wrong.

I did quite catch that, as the last sentence of my post said "that may not be what the fine was specifically for."

Also, I understand that failure to disclose CV risk isn't an off-label use, heh. Give me a little more credit than that. Didn't mean to imply that specifically was an off-label use, I was just trying to shed more light on what the company was doing, as it was all mentioned in the article. Paxil and Advair were the two mentioned in the article being promoted off-label.

Anyway, I was mainly responding to your point that "the off-label usage was not incorrect." If you meant that it was not incorrect in terms of relevance to the fine, then ok, that is one thing, I just interpreted it differently. My point was to try to not shed GSK in a favorable light at all. Anyway I think you're backpedaling like a star NFL cornerback right now and you're defending statements you did not at all make in your first post.

Edit: Where did I say that all off-label use is all incorrect? That's a straw man, bro. Yes, some of them could be legit. In this particular case it seems like most of them weren't.

Edit2: Also, Advair is an asthma drug, and Avandia is a diabetes drug. You're confusing two different drugs. Maybe in the future you SHOULD EDUCATE YOURSELF SO YOU DON'T LOOK SO IGNORANT NEXT TIME. The end.

Hello? Calvin?

Originally Posted by CaptainSSO

I did quite catch that, as the last sentence of my post said "that may not be what the fine was specifically for."

Also, I understand that failure to disclose CV risk isn't an off-label use, heh. Give me a little more credit than that. Didn't mean to imply that specifically was an off-label use, I was just trying to shed more light on what the company was doing, as it was all mentioned in the article. Paxil and Advair were the two mentioned in the article being promoted off-label.

Anyway, I was mainly responding to your point that "the off-label usage was not incorrect." If you meant that it was not incorrect in terms of relevance to the fine, then ok, that is one thing, I just interpreted it differently. My point was to try to not shed GSK in a favorable light at all. Anyway I think you're backpedaling like a star NFL cornerback right now and you're defending statements you did not at all make in your first post.

Edit: Where did I say that all off-label use is all incorrect? That's a straw man, bro. Yes, some of them could be legit. In this particular case it seems like most of them weren't.

Edit2: Also, Advair is an asthma drug, and Avandia is a diabetes drug. You're confusing two different drugs. Maybe in the future you SHOULD EDUCATE YOURSELF SO YOU DON'T LOOK SO IGNORANT NEXT TIME. The end.

I think you are missing the major point. The fact that there were harmful effects to the off-label use is 100% coincidental. When I read Calvin's post I dont see him at all saying that the the uses were correct. Just that whether or not the use was correct is irrelevant. If the off-label use of the drug caused immortality it would still be illegal for the drug company to push it.

Originally Posted by SpecterGT260

I think you are missing the major point. The fact that there were harmful effects to the off-label use is 100% coincidental. When I read Calvin's post I dont see him at all saying that the the uses were correct. Just that whether or not the use was correct is irrelevant. If the off-label use of the drug caused immortality it would still be illegal for the drug company to push it.

No, I understand that. I know that the fine was due to their off-label promotion in general and not the specific purposes for which they were prescribing the drugs-- I just felt like his post was sarcastic and condescending. Maybe I misinterpreted it, but if I was trying to write a passive-aggressive post that I could later defend as harmless I would have written it like he wrote his.

Originally Posted by CaptainSSO

No, I understand that. I know that the fine was due to their off-label promotion in general and not the specific purposes for which they were prescribing the drugs-- I just felt like his post was sarcastic and condescending. Maybe I misinterpreted it, but if I was trying to write a passive-aggressive post that I could later defend as harmless I would have written it like he did.

oh yeah, well.... that's totally not appropriate behavior

Originally Posted by SpecterGT260

oh yeah, well.... that's totally not appropriate behavior

Hey...all's fair in love, war, and the internets.

Originally Posted by CaptainSSO

I did quite catch that, as the last sentence of my post said "that may not be what the fine was specifically for."

Also, I understand that failure to disclose CV risk isn't an off-label use, heh. Give me a little more credit than that. Didn't mean to imply that specifically was an off-label use, I was just trying to shed more light on what the company was doing, as it was all mentioned in the article. Paxil and Advair were the two mentioned in the article being promoted off-label.

Anyway, I was mainly responding to your point that "the off-label usage was not incorrect." If you meant that it was not incorrect in terms of relevance to the fine, then ok, that is one thing, I just interpreted it differently. My point was to try to not shed GSK in a favorable light at all. Anyway I think you're backpedaling like a star NFL cornerback right now and you're defending statements you did not at all make in your first post.

Edit: Where did I say that all off-label use is all incorrect? That's a straw man, bro. Yes, some of them could be legit. In this particular case it seems like most of them weren't.

Edit2: Also, Advair is an asthma drug, and Avandia is a diabetes drug. You're confusing two different drugs. Maybe in the future you SHOULD EDUCATE YOURSELF SO YOU DON'T LOOK SO IGNORANT NEXT TIME. The end.

Calm down there brah. No need to get worked up.

I wasn't sure why you included the side effect in your post if you understood that. Again, we were talking about the legality of it and I thought that was pretty clear...but it just looks like that was a misunderstanding. I absolutely agree that there were off label uses that were incorrect and if you were to interpret that post in any way it would be to say that it was not necessarily the off-label usage that was incorrect. I've edited it so future generations won't be so confused. I'm really not backpedaling at all, that's just my main point was in the first place.

I also did say the wrong drug because you put them right after each other in the post...didn't even read the name in the next line. Whoops. The point is still that one is a side effect and one is an incorrect off label use but I think we've got that down by now.

I think that post was much less sarcastic than you thought. I was really trying to clarify what I meant in the first place because you made it clear that I didn't explain that well enough. That's why the post was so long.

Ugh finally here's what I said in the first place since you're upset about this "straw man" I threw out there:

Right right I think what needs to really be emphasized here is that it was NOT the off-label useage that was incorrect.

And here's what you said:

So to refute calvinhobess point I would say the off-label use WAS incorrect, although that might not be specifically what they were sued for.

We use the exact same wording except you say the off-label use WAS incorrect. So either we're both talking about SOME of the drugs or we're both talking about ALL of the drugs. If you're "refuting my point" then you're saying that ALL of the drugs off label use was incorrect because you're assuming I meant that ALL of the off label use was correct. You're not actually "refuting" any point if you mean SOME usage was incorrect because then I just mean SOME usage was correct and we're both right. In the end we're either both right or both wrong but if you actually think you're "refuting" some point that means we're both wrong.

So let's just agree to both be right?

Originally Posted by Freddie Mercury

The issue was GSK's promotion of the off-label use, which is not allowed.

I know. But physicians and patients often use a drug for off-label purposes. In many cases this is the best treatment available. So what is wrong with pharm companies advocating for off-label uses of their drugs? They did not market these drugs as FDA-approved for that purpose, which implies stronger evidence of its beneficial effect and would not be true, it seems like they only provided data to physicians. Why is that illegal? As a physician, I would want access to as much data on drugs as possible so that I could make the best recommendations to my patients. What is wrong with that?

Originally Posted by Dr Love

I know. But physicians and patients often use a drug for off-label purposes. In many cases this is the best treatment available. So what is wrong with pharm companies advocating for off-label uses of their drugs? They did not market these drugs as FDA-approved for that purpose, which implies stronger evidence of its beneficial effect and would not be true, it seems like they only provided data to physicians. Why is that illegal? As a physician, I would want access to as much data on drugs as possible so that I could make the best recommendations to my patients. What is wrong with that?

They do not have the training to practice medicine and therefore prescribe medications. Such practices are dangerous and unethical. There are obvious conflicts of interest (which also has implications to the data). If you want to look into off-label use data, do not get it from drug companies plenty of studies are going on in a continual fashion which look at unexpected outcomes with drug use.

Originally Posted by calvnandhobbs68

Calm down there brah. No need to get worked up.

I wasn't sure why you included the side effect in your post if you understood that. Again, we were talking about the legality of it and I thought that was pretty clear...but it just looks like that was a misunderstanding. I absolutely agree that there were off label uses that were incorrect and if you were to interpret that post in any way it would be to say that it was not necessarily the off-label usage that was incorrect. I've edited it so future generations won't be so confused. I'm really not backpedaling at all, that's just my main point was in the first place.

I also did say the wrong drug because you put them right after each other in the post...didn't even read the name in the next line. Whoops. The point is still that one is a side effect and one is an incorrect off label use but I think we've got that down by now.

I think that post was much less sarcastic than you thought. I was really trying to clarify what I meant in the first place because you made it clear that I didn't explain that well enough. That's why the post was so long.

Ugh finally here's what I said in the first place since you're upset about this "straw man" I threw out there:


And here's what you said:


We use the exact same wording except you say the off-label use WAS incorrect. So either we're both talking about SOME of the drugs or we're both talking about ALL of the drugs. If you're "refuting my point" then you're saying that ALL of the drugs off label use was incorrect because you're assuming I meant that ALL of the off label use was correct. You're not actually "refuting" any point if you mean SOME usage was incorrect because then I just mean SOME usage was correct and we're both right. In the end we're either both right or both wrong but if you actually think you're "refuting" some point that means we're both wrong.

So let's just agree to both be right?

Calvin...no, see...no. You got it all wrong.

You clearly meant "all," and I clearly meant "some."