OxyContin maker to plead guilty to federal criminal charges, pay $8 billion, and will close

[ThatRobGuy]

Purdue Pharma pleads guilty to federal criminal charges related to opioid crisis - CNN

New York (CNN Business)Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to three federal criminal charges for its role in creating the nation's opioid crisis and will pay more than $8 billion and close down the company.

The money will go to opioid treatment and abatement programs. The privately held company has agreed to pay a $3.5 billion fine as well as forfeit an additional $2 billion in past profits, in addition to the $2.8 billion it agreed to pay in civil liability.

 

[wing2000]

The money will go to opioid treatment and abatement programs. The privately held company has agreed to pay a $3.5 billion fine as well as forfeit an additional $2 billion in past profits, in addition to the $2.8 billion it agreed to pay in civil liability.

....isn't Purdue Pharma bankrupt?

 

[iluvatar5150]

Hopefully, they can go after the family with criminal charges and clawback a bunch of their money.

 

[ThatRobGuy]

I'm not sure what the implication is regarding manufacturers of the generic versions at this point.

Given that their exclusivity patents expired, and there are already several approved makers of the generic versions at this point...
Generic OxyContin Availability - Drugs.com

...I'm not sure how much damage is mitigated moving forward by the Name-brand manufacturer being shut down. I'm guessing it's more of a punitive measure in this particular case.

Allowing other drug makers to profit off the exact same concerning (and highly prone to be addictive) compound seems to be counterintuitive.

It's probably one of those drugs that should go the way of Quaaludes back in the day (meaning remove it altogether and find a better alternative)

 

[Tanj]

I'm not sure what the implication is regarding manufacturers of the generic versions at this point.

Given that their exclusivity patents expired, and there are already several approved makers of the generic versions at this point...
Generic OxyContin Availability - Drugs.com

...I'm not sure how much damage is mitigated moving forward by the Name-brand manufacturer being shut down. I'm guessing it's more of a punitive measure in this particular case.

Allowing other drug makers to profit off the exact same concerning (and highly prone to be addictive) compound seems to be counterintuitive.

It's probably one of those drugs that should go the way of Quaaludes back in the day (meaning remove it altogether and find a better alternative)

The issue is not the drug, which is an efficacious opioid analgesic with a far softer lethality and addiction profile than its nearest rival, morphine, and also has oral bioavailaibility. The issue is the activities Perdue engaged in to profit from inappropriate and illegal use, together with yet another example of why free market capitalism in the absence of decent government regulation is a bad idea.

Don't throw the baby out with the bathwater because the only knowledge you have of this drug is newspapers reporting on the crisis.

 

[FireDragon76]

The issue is not the drug, which is an efficacious opioid analgesic with a far softer lethality and addiction profile than its nearest rival, morphine, and also has oral bioavailaibility. The issue is the activities Perdue engaged in to profit from inappropriate and illegal use, together with yet another example of why free market capitalism in the absence of decent government regulation is a bad idea.

Don't throw the baby out with the bathwater because the only knowledge you have of this drug is newspapers reporting on the crisis.

Agreed. I'm not a fan of Oxy, but I think alot of the rhetoric out there in the public space is scapegoating of a drug that has very important practical applications for intractable pain in some individuals.

The opioid crisis exposes a much more pervasive reality in American life, that the US is the biggest drug consumer in the world, and chooses to medicalize its anomie and despair, rather than to address widespread social problems. You can't lay that at the feet of one drug company.

 

[ThatRobGuy]

The issue is not the drug, which is an efficacious opioid analgesic with a far softer lethality and addiction profile than its nearest rival, morphine, and also has oral bioavailaibility. The issue is the activities Perdue engaged in to profit from inappropriate and illegal use, together with yet another example of why free market capitalism in the absence of decent government regulation is a bad idea.

Don't throw the baby out with the bathwater because the only knowledge you have of this drug is newspapers reporting on the crisis.

What you're saying is only partially true...

It has a slightly lower lethality risk than morphine, but it doesn't have a softer addiction profile.

According to the NIH/CDC

They're also not in the same opioid family as morphine...

OxyContin's closest "drug-relative" would actually be Vicodin...and per the snippet above, oxycodone has a "substantially elevated abuse profile" when compared to both morphine an vicodin (hydrocodone).
We identified nine studies that met inclusion criteria. All were double-blinded, randomized, placebo-controlled crossover studies and scored 5 out of 5 Jadad scale. There was no consistent clinically significant difference between abuse liability of morphine and hydrocodone (Vicodin). Oxycodone (OxyContin) demonstrated high abuse liability on the basis of its high likability scores and a relative lack of negative subjective effects.

The reason I was drawing the comparison between OxyContin and Quaalude's is because of a trait they both share. They both solved a legitimate issue that sometimes needs medicinal intervention, but both also created a "very pleasurable euphoric high with fewer negative effects" than their counterparts, and were easy to misuse for non-medicinal purposes.

So I wasn't suggesting that we eliminate all opioids (severe pain cases definitely need them), my suggestion was that, much like Quaaludes were removed from the market, and replaced with better alternatives like Ambien (which isn't as easy to abuse as a party drug like "Ludes" were back in the day), the same needs to happen with oxycodone.

So your statement of "the issue is not the drug" is false. With regards to oxycodone (much like was the case with quaaludes), the issue is stemming from something unique about the particular drug, itself.


As far as the "capitalism absent regulation" aspect...I'd give that partial agreement, as the type of direct-to-consumer advertising (the whole "ask your doctor about XYZ" commercials) is something pretty unique to us and probably has fewer pros than cons.

 

[ThatRobGuy]

The opioid crisis exposes a much more pervasive reality in American life, that the US is the biggest drug consumer in the world, and chooses to medicalize its anomie and despair, rather than to address widespread social problems. You can't lay that at the feet of one drug company.

There's truth to that, but I don't even think it's confined to "despair" or "social problems". I think it's more of a "I want a quick fix that involves no effort on my part for this problem".

For instance, look at usage of statins, blood pressure medications, and even more extreme measures like gastric bypass procedures. (which don't carry a recreational abuse profile like painkillers)

You have a large number of people (regardless of race/economic status/etc...) who've basically said:
"I wanna eat whatever I want to eat, I want to eat till I feel stuffed every meal, and I don't want to exercise or make any changes to my diet whatsoever...gimme this pill or procedure that will cancel out the effects of that"

 

[RestoreTheJoy]

Purdue Pharma pleads guilty to federal criminal charges related to opioid crisis - CNN

New York (CNN Business)Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to three federal criminal charges for its role in creating the nation's opioid crisis and will pay more than $8 billion and close down the company.

The money will go to opioid treatment and abatement programs. The privately held company has agreed to pay a $3.5 billion fine as well as forfeit an additional $2 billion in past profits, in addition to the $2.8 billion it agreed to pay in civil liability.

I really don't get this. They made a pain control pill that was widely disseminated - and still is. I don't know how they are responsible for people misusing it - nor even how this is possible, given that this drug constipates like no other. ;0

That's like holding Ford or Toyota responsible for intentional car accidents.

 

[RestoreTheJoy]

What you're saying is only partially true...

It has a slightly lower lethality risk than morphine, but it doesn't have a softer addiction profile.

According to the NIH/CDC
View attachment 286972

They're also not in the same opioid family as morphine...
View attachment 286973
OxyContin's closest "drug-relative" would actually be Vicodin...and per the snippet above, oxycodone has a "substantially elevated abuse profile" when compared to both morphine an vicodin (hydrocodone).
We identified nine studies that met inclusion criteria. All were double-blinded, randomized, placebo-controlled crossover studies and scored 5 out of 5 Jadad scale. There was no consistent clinically significant difference between abuse liability of morphine and hydrocodone (Vicodin). Oxycodone (OxyContin) demonstrated high abuse liability on the basis of its high likability scores and a relative lack of negative subjective effects.

The reason I was drawing the comparison between OxyContin and Quaalude's is because of a trait they both share. They both solved a legitimate issue that sometimes needs medicinal intervention, but both also created a "very pleasurable euphoric high with fewer negative effects" than their counterparts, and were easy to misuse for non-medicinal purposes.

So I wasn't suggesting that we eliminate all opioids (severe pain cases definitely need them), my suggestion was that, much like Quaaludes were removed from the market, and replaced with better alternatives like Ambien (which isn't as easy to abuse as a party drug like "Ludes" were back in the day), the same needs to happen with oxycodone.

So your statement of "the issue is not the drug" is false. With regards to oxycodone (much like was the case with quaaludes), the issue is stemming from something unique about the particular drug, itself.


As far as the "capitalism absent regulation" aspect...I'd give that partial agreement, as the type of direct-to-consumer advertising (the whole "ask your doctor about XYZ" commercials) is something pretty unique to us and probably has fewer pros than cons.

Eh, I've been agreeing with some of your posts lately, but I'm going to disagree here. The existence of oxy isn't the problem; the overuse is intentional and fueled by both patients and doctors who served them.

It is exactly the same as the existence of marijuana or the existence of alcohol. Some people abuse them, and most do not, but no one is suing the manufacturers.

And again....how is this even possible (as an aside)? Anyone who has ever had a surgery gets this drug and it is impossible to go to the bathroom while taking it. They actually warn you in advance to take a stool softener to escape misery - and they aren't joking. So I really will never understand how anyone abused this particular one

 

[ThatRobGuy]

Eh, I've been agreeing with some of your posts lately, but I'm going to disagree here. The existence of oxy isn't the problem; the overuse is intentional and fueled by both patients and doctors who served them.

It is exactly the same as the existence of marijuana or the existence of alcohol. Some people abuse them, and most do not, but no one is suing the manufacturers.

And again....how is this even possible (as an aside)? Anyone who has ever had a surgery gets this drug and it is impossible to go to the bathroom while taking it. They actually warn you in advance to take a stool softener to escape misery - and they aren't joking. So I really will never understand how anyone abused this particular one

Per the NIH/CDC info I posted, the propensity for abuse is driven by a few different factors.

As I clarified before, I'm not suggesting that "opioids are the problem, we need to get rid of them", I'm suggesting that "oxy, in particular, has a trait that makes it a more prime candidate for abuse than others in the similar drug families"


Take this hypothetical...let's say there were two different medications aimed at preventing dental infections after oral surgery (and they both work nearly equally well with regards to their intended/stated purpose)

Drug A) causes severe loss of appetite as a side effect, and has no easy mechanism for recreational use.

Drug B) causes only a very mild loss of appetite, but is discovered that if you crush it up, and mix it in with an alcoholic beverage, can produce a euphoric feeling resembling that of MDMA (ecstacy).


There's something very unique about Drug B that makes it a prime candidate for misuse that's not shared by Drug A.


That's the aspect of oxycodone that's unique when compared to other opioids in the same family (like hydrocodone) or when compared to opioids in other families like morphine.

If all are aimed at pain relief, but one has fewer of the negative effects, and the added effect of a pleasurable euphoric feeling when misused, that one is going to be more of a target for abuse than the others.

So the simple comparison of "there are some people who smoke weed and drink who get very addicted, and others who don't" isn't really applicable.

A comparable example would be if there were a particular beverage (in the alcohol family) that produced more mild hangovers when consumed to excess, and created a much stronger feeling of euphoria compared to other alcoholic beverages. That drink would have a higher propensity for being abused than others.

 

[FireDragon76]

There's truth to that, but I don't even think it's confined to "despair" or "social problems". I think it's more of a "I want a quick fix that involves no effort on my part for this problem".

For instance, look at usage of statins, blood pressure medications, and even more extreme measures like gastric bypass procedures. (which don't carry a recreational abuse profile like painkillers)

You have a large number of people (regardless of race/economic status/etc...) who've basically said:
"I wanna eat whatever I want to eat, I want to eat till I feel stuffed every meal, and I don't want to exercise or make any changes to my diet whatsoever...gimme this pill or procedure that will cancel out the effects of that"

True.

And that attitude comes from a place of alienation and despair. Mentally healthy people simply do not think that way.

 

[ThatRobGuy]

True.

And that attitude comes from a place of alienation and despair. Mentally healthy people simply do not think that way.

That could be part of it.

However, in countries that have similar (or even higher) rates of depression and anxiety than we do, there's still not this same love affair with the idea of "I'm not going to change anything, just give me a quick fix for it".

For instance, we're on par in terms of depression/anxiety rates when compared to countries like The Netherland, Norway, Canada, Portugal, Ireland, etc... (Australia and New Zealand are even higher)


I think part of it could be a cultural aspect as well, specifically with regards to this notion that "not having absolutely everything on want in life like I see on TV" becomes a catalyst for depression and substance abuse...and that seems to be a luxury of being spoiled in westernized cultures... or that "being average" is somehow something to be depressed about.

This infographic is quite interesting I thought...

Objectively speaking (in terms of everything that a person could be happy or sad about in life or that could cause undo mental stress), there's no tangible reason why people living in Belgium/Finland/Norway should suffer from higher rates of anxiety and depression than people living in Uzbekistan, Burkina Faso, or Somalia.

I guess my only theory would be (and it's just a theory), that growing up with unreasonable expectations being instilled of what "a good life" or "success" is (that most people will never be able to accomplish) from a very young age could be playing a role.

https://www.psychologytoday.com/us/...-countries-citizens-are-more-likely-depressed

This article explains the phenomenon, but the author/article preemptively admit it's a tough puzzle to solve, but at the end, espouses a somewhat similar theory to what I mentioned, which was

Why is it that having more money as a country does not buffer its citizenry against mood problems, and in fact, the opposite is true? Ronald Kessler, a professor at the Harvard Medical School, and one of the study authors, may be on the right track when he said,"U.S. expectations know no bounds and people in other countries are just happy to have a meal on the table."

If a young person is dead set on becoming a professional athlete, movie star, etc... "I'm going to have millions of dollars, drive 5 sports cars, and travel the world in luxury", they're likely going to be let down by statistical reality...as to where a person of my humble origins is likely to set more reasonable goals, and be more likely to accomplish them.

 

[FireDragon76]

That could be part of it.

However, in countries that have similar (or even higher) rates of depression and anxiety than we do, there's still not this same love affair with the idea of "I'm not going to change anything, just give me a quick fix for it".

For instance, we're on par in terms of depression/anxiety rates when compared to countries like The Netherland, Norway, Canada, Portugal, Ireland, etc... (Australia and New Zealand are even higher)


I think part of it could be a cultural aspect as well, specifically with regards to this notion that "not having absolutely everything on want in life like I see on TV" becomes a catalyst for depression and substance abuse...and that seems to be a luxury of being spoiled in westernized cultures... or that "being average" is somehow something to be depressed about.

This infographic is quite interesting I thought...
View attachment 286988

Objectively speaking (in terms of everything that a person could be happy or sad about in life or that could cause undo mental stress), there's no tangible reason why people living in Belgium/Finland/Norway should suffer from higher rates of anxiety and depression than people living in Uzbekistan, Burkina Faso, or Somalia.

I guess my only theory would be (and it's just a theory), that growing up with unreasonable expectations being instilled of what "a good life" or "success" is (that most people will never be able to accomplish) from a very young age could be playing a role.

https://www.psychologytoday.com/us/...-countries-citizens-are-more-likely-depressed

This article explains the phenomenon, but the author/article preemptively admit it's a touch puzzle to solve, but at the end, espouses a somewhat similar theory to what I mentioned, which was

Why is it that having more money as a country does not buffer its citizenry against mood problems, and in fact, the opposite is true? Ronald Kessler, a professor at the Harvard Medical School, and one of the study authors, may be on the right track when he said,"U.S. expectations know no bounds and people in other countries are just happy to have a meal on the table."

If a young person is dead set on becoming a professional athlete, movie star, etc... "I'm going to have millions of dollars, drive 5 sports cars, and travel the world in luxury", they're likely going to be let down by statistical reality...as to where a person of my humble origins is likely to set more reasonable goals, and be more likely to accomplish them.

Well, some of it is uniquely American, especially due to the rapacious form of capitalism we have, now that the US is a center of a global hegemony/empire built upon psychological manipulation of a mass consumer culture. Chris Hedges discusses this in the short documentary, American Psychosis.

In reference to your observation you made that seems very keen, there's some evidence that countries that were highly influenced by Calvinism and Puritanism have more depression in response to job losses than those that don't. As you point out, having high expectations for material success, which is part of the so-called Protestant Work Ethic, tends to engender that.

 

[iluvatar5150]

I really don't get this. They made a pain control pill that was widely disseminated - and still is. I don't know how they are responsible for people misusing it - nor even how this is possible, given that this drug constipates like no other. ;0

That's like holding Ford or Toyota responsible for intentional car accidents.

Opiate addiction isn't always intentional. A lot of people get hooked because they were overprescribed for legitimate pain conditions.

I'm going from memory, so I hope I get everything right.... Purdue didn't just manufacture Oxy. They also advertised it as being safer than it was and didn't institute any safeguards over its abuse even though they could have and should have. There were rural appalachian counties, for example, where prescription rates approached 1 pill/day for every single person in the county.

If you're going to make a car analogy, it would be more like Ford or Toyota selling you a car that they advertised as having 150 hp and being safer than previous cars, when it actually had 1000 hp, a sticky throttle and bad brakes such that it was easy to get yourself into trouble but hard to get out of trouble. Then they conveniently ignored the underground racing clubs that started favoring their cars and the fact that they were shipping train loads of new cars to the middle of nowhere.

 

[RestoreTheJoy]

Opiate addiction isn't always intentional. A lot of people get hooked because they were overprescribed for legitimate pain conditions.

I'm going from memory, so I hope I get everything right.... Purdue didn't just manufacture Oxy. They also advertised it as being safer than it was and didn't institute any safeguards over its abuse even though they could have and should have. There were rural appalachian counties, for example, where prescription rates approached 1 pill/day for every single person in the county.

If you're going to make a car analogy, it would be more like Ford or Toyota selling you a car that they advertised as having 150 hp and being safer than previous cars, when it actually had 1000 hp, a sticky throttle and bad brakes such that it was easy to get yourself into trouble but hard to get out of trouble. Then they conveniently ignored the underground racing clubs that started favoring their cars and the fact that they were shipping train loads of new cars to the middle of nowhere.

Ok, if one is overprescribed, back it up. Who doesn't know to back off a drug when they aren't feeling right or are feeling too doped up? Besides, even accepting that one was given too high a dosage, how is this the manufacturer's fault and not the prescriber's fault?

They are all in it for the money. Make no mistake about that. We are bombarded with drug ads all day every day, with an implicit erroneous assumption that one lives a better life through prescriptions.

No, the car analogy does not work. It's the driver's fault if he drives too fast, regardless of the hp. It's the manufacturer's fault if the brakes are bad, not driver error, and that should be caught in manufacturing and testing.

 

[iluvatar5150]

Ok, if one is overprescribed, back it up. Who doesn't know to back off a drug when they aren't feeling right or are feeling too doped up? Besides, even accepting that one was given too high a dosage, how is this the manufacturer's fault and not the prescriber's fault?

Over-prescribing isn't merely about the patient feeling too doped up, it's also about prescribing something that's stronger than necessary and about keeping somebody on the medication for longer than necessary.

Yes, some of this is on the prescribers - and in some cases, a lot of it is on them. But Purdue also sold this medication as being safer than it was. Even ignoring their aggressive marketing and quasi-bribery, they still lied about its behavior so that even the most cautious doctors and patients could wind up in trouble.

They are all in it for the money. Make no mistake about that. We are bombarded with drug ads all day every day, with an implicit erroneous assumption that one lives a better life through prescriptions.

No, the car analogy does not work. It's the driver's fault if he drives too fast, regardless of the hp.

It's not the driver's fault if he unwittingly gets into a car that he's unable to handle. Youtube is full of videos of folks in high-end sports cars doing what are otherwise innocuous maneuvers and inadvertently spinning out and crashing because they don't know how to handle that much power. Making a left turn, for example, from a dead stop in a 700hp rwd mid-engine Ferrari is not the same as doing it in a 150 hp fwd front-engine Mazda. I would have to try really hard to mess up that move in my Mazda - and even if I did, the recovery is basically just letting off the gas and starting over. But feather the throttle wrong in something like an F8 with traction control off and you're gonna lose the back end and plow into something.

It's the manufacturer's fault if the brakes are bad, not driver error, and that should be caught in manufacturing and testing.

Purdue lied to people about the safety of their product and then pushed them to use a lot of that product. As I stated earlier, the nature of this product is such that 1.) it's easy to get yourself into trouble without realizing it and 2.) it's hard to get out of trouble once you realize there's a problem. It's on point #2 where the brakes analogy comes in - okay, you're going faster than you should be, so the corrective measures are to lift off the gas and apply the brakes. But if the throttle sticks and the brakes don't work, you now can't get out of trouble. Purdues products are very addictive and breaking that addiction is hard.

 

[RestoreTheJoy]

Over-prescribing isn't merely about the patient feeling too doped up, it's also about prescribing something that's stronger than necessary and about keeping somebody on the medication for longer than necessary.

Yes, some of this is on the prescribers - and in some cases, a lot of it is on them. But Purdue also sold this medication as being safer than it was. Even ignoring their aggressive marketing and quasi-bribery, they still lied about its behavior so that even the most cautious doctors and patients could wind up in trouble.

....

Purdue lied to people about the safety of their product and then pushed them to use a lot of that product. As I stated earlier, the nature of this product is such that 1.) it's easy to get yourself into trouble without realizing it and 2.) it's hard to get out of trouble once you realize there's a problem. It's on point #2 where the brakes analogy comes in - okay, you're going faster than you should be, so the corrective measures are to lift off the gas and apply the brakes. But if the throttle sticks and the brakes don't work, you now can't get out of trouble. Purdue's products are very addictive and breaking that addiction is hard.

No...Purdue didn't have access to the customer to "push them to use a lot". That's squarely on anyone who prescribed them - and on the user.

Don't tell me the user has no responsibility because he does.

 

[iluvatar5150]

No...Purdue didn't have access to the customer to "push them to use a lot". That's squarely on anyone who prescribed them - and on the user.

I didn't say they had access to the end-user; I said they lied to "people." The bulk of their marketing was to physicians, who are "people." Purdue lied to physicians and pushed physicians to use a lot of their product.

The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy

Don't tell me the user has no responsibility because he does.

I don't know what your beef is, but patients are typically not qualified to make determinations about which medications are or are not appropriate for their conditions - especially when we're talking about medications that are relatively new to the market and at a time (late 90's-early 2000's) when Dr Google wasn't the fount of information it (sort of) is now.

If my doctor tells me something is safe and I don't have anything suggesting otherwise, I'm probably going to trust him. Maybe he's lazy; maybe he was conned by a family of billionaire fraudsters. Either way, it's not my fault if I get hooked because somebody upstream of me screwed up. The patients who innocently got hooked on this stuff (and there were a lot of them) were the least culpable in all of this. The Saklers, OTOH, knew they had a dangerous product, lied about its safety, and made billions of dollars pumping it into communities that had no possible legitimate need for those quantities.

 

[sesquiterpene]

No...Purdue didn't have access to the customer to "push them to use a lot". That's squarely on anyone who prescribed them - and on the user.

Nonsense. Their customers were the physicians, some of whom they knew were diverting sales to the black market - they even kept a list - and did nothing about it. They lied about the potential for addiction, while promoting higher and higher doses of the drug, and for patients to stay on them longer.

There' a reason for the criminal convictions, and for the many lawsuits they lost: They were guilty of reckless and criminal behavior, and over a lengthy period of time. Here's a source for dozens of articles Ars Search | Ars Technica

You don't need to be so ignorant of their wrongdoing