Purdue Pharma files for bankruptcy with $10B plan to settle claims
bloomberg.com
bloomberg.com
The Sackler Family – A Secretive Billion Dollar Opioid Empire - https://www.youtube.com/watch?v=zGcKURD_osM
However, food for thought on that same subject is the over prescribing of amoxicillin and other similar class of drugs for viruses. The doctor is operating a business and his/her clients want a solution to their problem, so they write a script as they want to keep their customer happy and it “can’t be too bad”.
There’s a case to be made that a certain amount of immediate gratification expected on the part of the consumer is a large contributing factor to overprescribing in general.
However, in this case, Purdue was very much in the wrong and should not have been encouraging over prescription of a highly addictive drug.
Lo and behold, people are addicted to OxyContin, some start looking for more immediate-relase formulations of opioids because they don't feel right even on 80mg Oxy tablets, and hundreds of thousands who otherwise would have been alive with chronic pain are now dead of overdose. Meanwhile, research is showing that opioids are not very good for chronic pain and other approaches, usually multimodal approaches, are better, including NSAIDs, gaba-ergic drugs like gabapentin and pregabalin, ketamine, physical therapy, psychological retraining, meditation, acupuncture, etc.
That was/is the position of the IOM though. Was Purdue involved with convincing the IOM to adopt that position?
Lots of times Doctors are providing a service and the expectation is “I feel bad, give me some pills to help” when in reality many cases are rest & recover but as a client can you imagine paying your social media person $500 for them to say “doing nothing is the right move”? Not really, no.
There are a lot of different drugs. You can't lump them all together!
Actually some of us do. Just open the floodgates when it comes to what you're able to have access to.
Spending money enforcing prohibition feels less helpful than spending that same money on treatment of underlying issues or addressing other social problems that lead to drug use in the first place. Rather than criminalize the use behavior, which doesn't do anything to save lives in any real way, try to fix the actual problem rather than just sweep it under the rug of the criminal justice system.
Legally selling the drug is orthogonal from morally/ethically dealing with the consequences of the drug, including regulating how it is sold, how it is marketed, how it deals with its own consequences.
1. Overprescription, in the US, there were 240 million opioid prescriptions in the US in 2015, enough for one for every adult in the general population.[1]
2. Poor mental health treatment, "in the United States, 18.7% of all patients with mental health conditions receive 51.4% of the total opioid prescriptions distributed each year, meaning that having a mental health disorder was associated with a two-fold greater use of prescription opioids"[1]
3. Greater availability + lower cost and higher purity of opioids sold by criminal orsg. Mexican criminal orgs have been pushing much greater amounts of opioids in the last ten years, probably due to profits from marijuana being undercut. Prescription drug OD deaths have actually decreased as people switch from controlled substances to heroin/other opiates.[2]
4. Lack of access to effective treatment procedures. The US is woefully inadequate in this regard. "n the United States and Canada, rehabilitation programmes are still mainly abstinence based (Annan et al., 2017[75]). More specifically, in the United States only 8-9% of all substance treatment facilities between 2006 and 2016 had MAT programmes certified by SAMHSA...This happens despite evidence showing that opioid users who are treated only with psychological support are at twice greater overdose death risk than those who receive opioid agonist pharmacotherapy (Pierce et al., 2016[77])"
5. Stigmatization causing addicts not to seek treatment. "Research indicates that stigma contributes to individuals poor mental and physical health, non‐completion of substance use treatment, delayed recovery and reintegration processes, and increased involvement in risky behaviour (e.g. needle sharing)"
OxyContin is a controlled substance, so it's not actually legal. Here is an excerpt from an OECD publication on the opioid crisis on a specific case of decriminalization of opioids:
In 2001, Portugal decriminalised the possession and consumption of all narcotics and psychotropic substances for personal use, intended as the quantity required for an average individual consumption during a period of ten days. Exceeding this quantity, criminal procedures apply. Portugal’s decriminalisation reform has been particularly influential, since by introducing a de jure decriminalisation (changes in the law instead of changes in the daily practice), it has been a pioneer of the explicit decriminalisation of all drugs. Some of the main benefits of decriminalisation mentioned by Portuguese authorities can be summarised as follows:
Changes in the mind-set of the general population, contributing to consider drug use disorders as a medical condition rather than a criminal offence.
Creation of supplementary entrance doors to the public health system, particularly, through the Commissions for the Dissuasion of Drug Dependence.
Coherence enhancement between the health and judicial systems, markedly, to provide and expand access to public health interventions.
...
The decriminalisation of drugs is controversial in nature. However, empirical evidence shows that following decriminalization, Portugal has not witnessed major increases in drug use, but has experienced reductions in problematic use, drug-related harms (e.g. HIV-AIDS, hepatitis, overdose deaths) and criminal justice overcrowding (EMCDDA, 2018[223]; Hughes and Stevens, 2010[224]; Greenwald, 2009[225]). In addition, decriminalisation seems to have caused no harm through lower illicit drugs prices, which would lead to higher drug usage and dependence (Félix and Portugal, 2017[226]).[1]
I recommend checking out the sources I've linked, there's a lot of interesting information in them.
1. https://www.oecd-ilibrary.org/social-issues-migration-health...
2. https://www.overdosefreepa.pitt.edu/wp-content/uploads/2017/...
Sounds like this arm of the company will end up controlled by a government trust. The best outcome would probably be the government running the operation at break even, lowering costs, and heavily regulating how much product it could give to hospitals.
But also the Sacklers are only like 8% of the problem. All the rest of the opioids, (92%), came from other companies. So, theoretically, if we confiscated all of the wealth of all of the owners and stockholders in all of these companies we'd get the money we need to at least ameliorate some of the carnage. Because we'd have at least 90% more than we'd have by just confiscating the Sackler wealth alone.
All that's just theory though. I don't even know if it's possible to hold ownership responsible? Because wouldn't that put people who buy stock in whatever company at risk if the company was doing something sufficiently untoward?
But I get it. Someone dies and it’s the drug dealers fault, and punishing them will make everyone feel better. Except it doesn’t do anything about the actual problem (opioid addiction).
It feels to me like the elation here is because the Sacklers are rich and people really don’t like that, rather than any sort of victory in combating opiate addiction.
That’s far more than just manufacturing and opened them up to significantly increased liability.
The lying in marketing, over the period 1995-2001, was already litigated in 2007.
https://katherineclark.house.gov/_cache/files/a/a/aaa7536a-6...
https://www.statnews.com/2016/09/22/abbott-oxycontin-crusade...
But again, the Sackler's are only 8% of the problem. So if you go after them, and the owners and stockholders of the companies that provided the other 92% of opioids, and the doctors who wrote the prescriptions in bad faith, you probably come up with an amount of money that could make a dent.
https://arstechnica.com/science/2019/05/world-health-organiz...
When they learned doctors were prescribing it for eight hours, they tried to "re-train" them to use the "proper" (read: their) dosing recommendation, because there were cheaper drugs with six of eight hour doses.
Sure, the doctors made the prescriptions, but you, and I, and everyone who thinks honestly about it for two and a half seconds realizes that no matter what the recommendation is, enough people who are in bad enough pain to be prescribed oxy will take it when they need it, recommendation be damned, that to have issued that recommendation in the first place was an act of bad faith.
They marketed the drug on a lie in order to get doctors to prescribe it, which fueled — if not created — an epidemic, which has killed tens of thousands of people. Their hands are not clean, here.
This seems a bit of a stretch to me.
The doctors prescribed it, even given readily available research, the FDA approved it, knowing full well this was a risk. Those are the guilty parties here. Purdue filled their role just fine, they just happened to be making an opiate and so they're getting chased for it now because China is dumping fentanyl. Pretty ridiculous really.
“Purdue Pharma used front organizations and sponsored research to deceive the World Health Organization and corrupt global public health policies”
If that is true and public policy was corruptly manipulated , how can you claim that this is all ok because it was allowed by public policy?
Public policy that can be readily manipulated by bad actors (as the drug industry is certainly full of) should not be used as the final say for anything. Systems need to be able to tolerate: corruption, false information, and true but misleading information. Our regulatory systems in general seem to struggle with any of the above. If "health authorities" (to avoid naming any particular organization) can only effectively screen out good actors inadvertently engaged in bad behavior, then they're effectively useless - because bad actors do exist, and they're vastly more dangerous than the former.
The same is even true of things such as the FAA and the aviation industry where there were analogous issues. All of this is emphasizing that these organizations, which can be quite the burden on 'good players', are ultimately ineffective at restraining bad players which (I suppose depending on your philosophical view) should be their primary purview.
Making wide sweeping statements based on very specific issues simply demonstrates ignorance of how these organizations actually interact with the systems they regulate.
PS: As to FDA ‘rubber stamping’ the drug, using opioids for treatment of end of life cancer pain is perfectly reasonable. OxyContin is just one of a huge list of similar drugs that have been in use long before this outbreak. It’s not the chemical that’s the problem is the other actions by the company.
And this story repeats over and over since our entire regulatory system is, when it comes to the big and influential players from Purdue to Boeing, mostly just glorified self regulation. And that leads to a worst of both worlds scenario. We get the lack of oversight inherent in self regulation, yet it's paired with an undue faith in our regulatory systems as many people don't understand the actual regulatory processes, or lack thereof.
[1] - https://www.washingtonpost.com/national/health-science/fda-d...
Opioids are addictive and become less effective over time. Opioids can also be a valuable tool for relief of severe pain over a short to moderate period. The actual issue is not the drug in this case it’s a drug company pushing for more scales.
PS: I have seen a friend become addicted while in cancer treatment. But, I have also been prescribed opioids after major surgery. So yes they are clearly extremely dangerous, but they can treat levels of pain that are difficult to describe.
(Under capitalism) many costs of having PtLds are externalized.
The possibility to bankrupt a company without losing more than you put into the venture is in my eyes a feature of capitalism, not a bug.
There probably needs to be some exceptional way in law to pierce the shell of limited liability and go after officers, perhaps even claw back from investors and shareholders.
(In practice, however, managers are only rarely put in jail, both because it's notoriously difficult to prove white-collar crime (except in few cases, like insider trading, which are the pursued with extra vigor), and because CEOs are generally rich and well connected... but the problem there is corruption, not some inherent feature/bug of the idea of limited liability company.)
We take money earned from theft and drug dealing, we take the stolen car from the person who innocently bought it. There's an offence of receiving stolen property. We don't take the millions from the execs who made millions pushing pharmaceuticals illegally, or the nuclear plant CEO and shareholder that has now, by dint of closure, given the job of decommissioning to the state - i.e. all of us. Once in a blue moon there's a criminal prosecution, but they just about always manage to stay wealthy.
We need to rethink the limits of limited liability as it's become a convenient shield to hide all sorts of unethical, shitty and outright illegal behaviour behind.
> Limited liability only protects the capital of the shareholders,
No, it also protects shareholders from crimes the PtLd commits in order to "serve them". This is a main problem with PtLds imho.
1) the fine needs to be fair to the society (often we see these "slap on the wrist" fines for big corps, that's just disgusting and shows how much our democracies are disfunctional)
2) i suggest this because i want the shareholders to be pushing their companies to ethical behavior.
3) it is very important that companies are also held liable for unethical behavior in other countries, and/or even for unethical behavior of subsidiaries (the foxcons and the likes).
4) When the fine is larger than the company's worth, collect it from the shareholders.
No, the correct solution already exists - the criminal justice system going after criminals that did crime - it just doesn't work very well (especially when criminals are rich - e.g. Epstein - no need for "limited liability company").
> Then noone would invest.
i disagree, you just only invest in ethically sound endeavours. and thats exactly what im trying to achieve by my suggestions. starve bad-business from investment and/or people willing to take ownership. and make investors also do dilligence on the ethical side, instead of only an assessment of books+team+product+market.
"Sorry Grandpa, I know you thought that company was on the up and up, but we're gonna have to take your retirement."
russia didn't have the economic basis to get rid of basic material scarcity in 1917, and also was constantly under attack by capitalism, and so it devolved into an undemocratic mess until it reverted (now everything is even worse there).
The important thing to recognize is that the ruling class - whoever owns property and is able to use that to exploit workers - will control the government and make laws that benefit them.
this is a big differences... I think tomp is explaining this difference somewhere in this thread.
This is why I think the argument that a corporation only has a duty to it's stockholders is rank bullshit.
I'd wager that at a societal level we roughly break even +/- a little bit in either direction. For every mega-corp abusing their legal status there's a few thousand small and medium businesses that do not have to worry (as much) about being sued into oblivion by some ambulance chaser over something that is not the result of malice. (I'm speaking about various private liability limiting corporate structures in general here.)
Limited liability is directly as and exactly an externalization of costs; that's all that it is.
It's one that evolved hand in hand with capitalism, sure, but if it exists in a non-capitalist system it has the same effect.
The system is bought by folks like these. If you think the system will punish them, then I suggest taking a look at precedence for folks like them. It's not in the favor of the general public.
[1] https://www.dea.gov/press-releases/2019/05/13/pill-mill-doct...
The problem is that the prescribing guidelines, which were written by the pharmaceutical companies themselves, described a regimen that would get pretty much anyone physically addicted to their product.
So you had doctors acting in good faith, prescribing medications only when indicated and following their manufacturer's prescribing guidelines, inadvertently creating new addicts where the manufacturer's literature said there would be none.
Not only that, but we spent several decades treating chronic pain patients with opioids, such that they are completely dependent on that class of drugs to manage their condition. Only very recently have prescribing guidelines adjusted to reflect the reality that opioids are not a good treatment for chronic pain. When those pain patients are driven off of their opioid prescriptions, even if their doctor is well-meaning, some of them turn to heroin/fentanyl to manage their pain.
I can't recall the story exactly but there was a doctor who spoke out against a popular medication. He found that it increased a chance of a heart attack I believe by over 50%. They released a small study in a journal and his existence became a living hell. Eventually, the knowledge became main stream.
I for example had a serious reaction to cipro, left me with chronic pain. This reaction is starting to become common knowledge, yet I have found a single doctor willing to put down possible side effects of cipro in my chart. People have been reporting these side effects to FDA for 15+ years, it is affecting many people but symptoms take up to 12 months to surface and doctors don't want to accept it. I have talked to number of people diagnosed with fibromyalgia for example that later realized they took cipro for UTI right before symptoms began. Plus, the FDA has been making the label more severe almost every year. The European organization EMA suggested doctors use these medication only in life threatening infections.
what kind of chronic pain do you have?
i've had persistent joint issues that started shortly after a round of levaquin, a very similar drug.
Popping/clicking joints, and not intense pain just dull/achy. These drugs are known to cause peripheral nephropathy and tendinitis. I actually just read an interesting blog about a guy that is insanely fit, recently was given levaquin with prednisone, and continued to lift. Then, tendon in his arm snapped. He is documenting very well how his body is deteriorating and what new symptoms he is experiencing week to week. I think it would be worth posting on HN, I will send you a link when I find it.
Edit: It appears any flouroquinolone can cause these symptoms, this includes levaquin, cipro, avelox. Also, symptoms can develop after a single pill or 150 pills. It is insanely odd. Taking it with a steroid significantly increases chances of having a very negative reaction.
Excess payments to ownership (especially if you think the company is about to face a huge liability) is a classic example of one of the justifications for a judge to do just that: make the owners personally liable rather than just the company.
Don’t store your gold next to a nuclear reactor and all.
https://www.statnews.com/2019/09/09/purdue-pharma-data-downp...
As far as I know, generic manufacturers of off-patent drugs usually aren't sued.
On the one side, they don't actively promote/market their products to prescribers or patients, but I'd still think they share some blame by manufacturing it.
Nah. Opioids are an essential medication. The problem is not that OxyContin exists, it's the creation of irregular demand for it through the actions that Purdue Pharma are having to settle for.
The news in that piece is that NY discovered the transfers at all. The transfers themselves are a decade old. The payments to the Sacklers from Purdue are from 2008-2016 but the lawsuits only date to 2018. All of this is in the article if you read it.
I.e., no self-payments after lawsuits became material threat.
Who's misreading what now?
Those substantial transfers ($1B) were a decade ago.
The sentence you quote does not appear in the NYTimes piece and is, in comparison, peanuts. I do not have access to the Bloomberg piece for full context, but the sentence you quote does not say the movements were self-payments from Purdue rather than just personal transfers between personal accounts. It also does not say all $20M was in 2018; there could be a $1k wire in 2018 for all we know from the single sentence.
I'm pretty sure that was obvious to many people. But it was probably especially obvious to the people lying about it to make billions of dollars.
The lawsuit is alleging systematic fraud and requests an order for the Sacklers to return any transferred assets; and to restrain them from disposing of any property. https://ag.ny.gov/sites/default/files/oag_opioid_lawsuit.pdf
Interesting that these decisions are so political. States with republican majority and AGs agreed to settlement, the states with democratic majority did not. Only four AG's favoring the settlement are democrats.
Dont get me started on testorone or ADHD medication hypocrisy.
Shouldn't they look at the fund the company had on the "day that the lawsuit started".
Where ever they funneled the money, I am sure they are just look at the bank statement.
Also not all US based litigants are part of the settlement that is being worked out. There are also individuals who are being personally sued that aren't part of this as well.
Their fortune is safe.
> "Piercing the corporate veil" refers to a situation in which courts put aside limited liability and hold a corporation's shareholders or directors personally liable for the corporation’s actions or debts.
Even within traditional US Bankruptcy codes, there could instead be a Chapter 7 liquidation bankruptcy. In which the company is simply (or not so simply) liquidated and all assets used to pay creditors. Purdue pharma isn't a public company. I'm not sure how to look up it's net worth.
The Sacklers will of course prefer whichever will lose them the least money.
That's before we start talking about the ways in which a company's owners can indeed legally be liable for the company's fraudulent or criminal behavior, and long before we start talking about the guillotines.
https://www.drugabuse.gov/related-topics/trends-statistics/o... Fig 3-5 & descriptions.
* Rate of conversion from on-label opioid prescription to addiction ("opioid use disorder") is lowish; this metastudy[1] claims 8-12% on average, but the 95% CI is anywhere from 3-17% and I'm not sure what they're measuring the percentage of (i.e., long-term prescriptions might both be more represented in the data and have higher conversion rates) — I doubt 8-12% of people who get 3 days of vicodin for their wisdom teeth extraction develop an opiate use disorder. They also point out that some studies showed misuse rates below 1% and "significant variability remains in this literature." We should expect these rates to fall as tighter prescription quantities from the last several years impact "leftover" pill rates.
* The rate of conversion from prescription opioid addiction to heroin is low; 4-6% per the government.[2]
* Overall opioid-involved overdose annual deaths in the US rose from 8000 in 1999 to 47600 in 2017; of those, the prescription-involved number rose by 13600 deaths (+300%), from 3400. Conversely, the non-prescription-involved deaths rose from by 26000 deaths (+465%), from 4600.[3](Figs 3-4) 26000/39600 = ~66%. (The population has also grown about 17% over that period, but that doesn't change the calculus too much.)
* Therefore: the overall growth pattern in opioid deaths in the last two decades is largely accounted for by heroin and other non-Rx use, which are a tiny population with a very high (and rising) death rate. The rising death rate is mostly due to the surge in black market sale of fentanyl as "heroin."[3] (esp. figures 4-5 and associated text) (Perhaps as a result of DEA and other restriction on the supply of the relatively safer, but less dense, heroin, and restriction on supply of the vastly safer prescription opioids.)
* Notably, the number of non-fentanyl-involved prescription opioid-involved deaths has actually been in decline since 2011![3] (fig. 4.), despite a rising population. Let me echo that since it's really important: prescription opioid-involved overdose, ex fentanyl, both in number and per capita rate, HAS BEEN IN DECLINE SINCE 2011! Why doesn't any news story on opioids in the US headline with that? The primary reason the overall prescription opiate-involved death rate hasn't tracked that decline is rising co-(ab)use with illicit fentanyl, and its relatively higher death rate.
If we could wave a magic wand and wipe (illicit) fentanyl off the earth, our annual opioid death rate would fall by something like half.
[1]: https://www.ncbi.nlm.nih.gov/pubmed/25785523
[2]: https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdos...
[3]: https://www.drugabuse.gov/related-topics/trends-statistics/o...
https://news.ycombinator.com/item?id=20973171
Excerpt:
Given we don't have a magic wand, what can we do? Obviously we can't stop fentanyl
from entering our borders or being synthesized illicitly here. We can (and have)
leaned on illicit fentanyl-producing countries like China and Mexico to make those
businesses less lucrative. We can do harm reduction things for the vulnerable
population — which is mostly heroin users. We could legalize heroin with a
prescription for existing addicts?
Harm reduction stuff: Provide free/cheap testing for fentanyl adulteration? Make
naloxone available without prescription, on the shelf, for cheap or free, and
encourage businesses and residents to keep some around, even if they aren't users and
don't know any users? Maybe provide monitored, safe injection sites where addicts
overdosing can be assisted immediately if needed but are not arrested or forced into
any overbearing programs. Maybe even supply quality- and quantity-controlled heroin
to these addicts for use on-site to reduce likelihood of overdose and even allow
people to taper off if they want to.
Pick any level of government. This doesn't really have populist mandate even in Blue states and you can be damn sure Republican Governors are going to reject any "give drugs to addicts" proposal on their desk, if it even makes it through state legislatures. Meanwhile, Congress is stalled with a Democrat-controlled house and a Republican Senate that won't pass any laws. I don't see Trump taking ... positive executive action on this, either.
Maybe some harm reduction can be done at the municipal level, but that probably leaves some of the worst hit parts of the country (rural areas in Red states) without help.
And there we already have a problem. Off-label prescribing of opioids are a huge problem.
They’re really not supposed to be used so frequently for chronic non-cancer pain, but they’re used all the time for it.
And that’s a much bigger market than chronic cancer pain patients, because of life expectancy.
Cancer will often kill you, your back pain won’t.
I know off-label is specific industry jargon and it doesn't mean the way I tried to use it; sorry for the confusion.
Totally agree that chronic pain is a hard problem and tolerance effects make opioids a non-ideal long term solution. That said, I am neither a Doctor nor a researcher in the pharma industry so I don't have a lot of helpful suggestions for anything better than opioids today.
In this specific context? Sure, it's subjective and reasonable people can disagree.