Submitted via IRC for AzumaHazuki
[Purdue Pharma] announced this week that the US Food and Drug Administration has granted fast-track status to its investigational drug nalmefene hydrochloride (HCl), an injectable, emergency treatment intended to rescue people suspected of having an opioid overdose. Purdue suggests that nalmefene HCl’s effects last longer than the similar emergency opioid antagonist naloxone. As such, the company hopes nalmefene HCl will out-compete naloxone at reversing overdoses from the most highly potent opioid, namely fentanyl, which is currently driving the alarming numbers of opioid overdose deaths. The FDA’s fast-track status will speed the development and regulatory review of the drug.
[...] In the statement this week, Purdue once again side-stepped any involvement in initiating the epidemic, focusing solely on illicit drug use. Purdue’s president and CEO, Craig Landau was quoted as describing the problem simply as “Fentanyl and illicit opioid deaths continue to increase in the United States, fueled increasingly by overdoses of this class of compounds.”
[...] Purdue announced that it doesn’t intend to make money on the new drug. “As part of Purdue’s commitment to advance meaningful solutions to address the opioid crisis, the company will work to bring forward this option with the commitment not to profit from any future sales of this drug.”
[...] Still, according to internal discussions at Purdue that were made public in a lawsuit brought by the Commonwealth of Massachusetts, Purdue and members of the wealthy Sackler family that owns the company had carefully researched the money-making potential of treatments aimed at reversing the epidemic.
An un-redacted section of the lawsuit describes a secret plan called Project Tango, which explored Purdue’s expansion into selling treatment options.
Related Stories
OxyContin Maker Purdue Pharma to Plead Guilty to Three Criminal Charges
OxyContin maker Purdue Pharma to plead guilty to 3 criminal charges as part of an $8 billion-plus settlement
WASHINGTON (AP) — Purdue Pharma, the company that makes OxyContin, the powerful prescription painkiller that experts say helped touch off an epidemic, will plead guilty to three federal criminal charges as part of a settlement of more than $8 billion, Justice Department officials told The Associated Press.
The company will plead guilty to a criminal information being filed Wednesday in federal court in New Jersey to three counts, including conspiracy to defraud the United States and violating federal anti-kickback laws, the officials said.
The deal does not release any of the company's executives or owners — members of the wealthy Sackler family — from criminal liability. A criminal investigation is ongoing.
The officials were not authorized to discuss the investigation publicly and spoke on condition of anonymity.
Also at: Business Insider, CBS News, and ABC News.
Guilty pleas? You seldom see that - these corporates always seem to get away with weasel word statements to the effect, "We acknowledge no wrongdoing blah blah blah . . . "
Purdue Pharma Pleads Guilty to Opioid Crisis Charges, Will Become a Public Benefit Corporation
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.
"Purdue Pharma actively thwarted the United States' efforts to ensure compliance and prevent diversion," said Drug Enforcement Administration Assistant Administrator Tim McDermott. "The devastating ripple effect of Purdue's actions left lives lost and others addicted."The company doesn't have $8 billion in cash available to pay the fines. So Purdue will be dissolved as part of the settlement, and its assets will be used to create a new "public benefit company" controlled by a trust or similar entity designed for the benefit of the American public. The Justice Department said it will function entirely in the public interest rather than to maximize profits. Its future earnings will go to paying the fines and penalties, which in turn will be used to combat the opioid crisis.
That new company will continue to produce painkillers such as OxyContin, as well as drugs to deal with opioid overdose. Deputy Attorney General Jeffrey Rosen, who announced the settlement, defended the plans for the new company to continue to sell that drug, saying there are legitimate uses for painkillers such as OxyContin.
Also at The New York Times, Bloomberg, NBC, and CBS.
Previously:
City of Everett, Washington Sues OxyContin Maker Purdue Pharma
South Carolina Sues OxyContin Maker Purdue
Purdue Pharma to Cut Sales Force, Stop Marketing Opioids to Doctors
Colorado Attorney General Sues Purdue Pharma
OxyContin Maker Purdue Pharma May File for Bankruptcy to Disrupt Lawsuits
After Pushing Addictive OxyContin, Purdue Now Pursuing Overdose Antidote
Purdue Pharma to Pay $270 Million Settlement to Oklahoma
Report Finds that Purdue Pharma Infiltrated WHO, Manipulated Opioid Policies to Boost Sales
Opioid Talks Fail, Purdue Bankruptcy Filing Expected
Makers of OxiCotin, Purdue Pharma, Files Reorganization Chapter 11 "Bankrupty"
Sacklers Threaten to Scrap Opioid Deal If They Aren't Shielded From Lawsuits
Report: Sacklers Using Fake Doctors, False Marketing to Sell OxyContin in China
OxyContin Maker Purdue Pharma LP Said to be Brokering Plea Deal in Criminal Probe
(Score: 0) by Anonymous Coward on Sunday March 17 2019, @12:07PM (10 children)
This is horrible for people, but good for stockholders. These actions do not come as a surprise and may have been part of their long term strategy.
I wonder if these people are related to Shkreli somehow?
(Score: 2) by Runaway1956 on Sunday March 17 2019, @12:10PM (6 children)
For that reason, I think we should explore that bit in the constitution about "cruel and unusual punishment".
Is being drawn and quartered truly cruel? Or, being fed to ravenous lions, wolves, or just some mangy dogs? Surely, firing squad isn't terribly cruel or unusual?
(Score: 0) by Anonymous Coward on Sunday March 17 2019, @12:20PM (3 children)
Still resenting the merger of your health insurer, I see.
(Score: 2) by Runaway1956 on Sunday March 17 2019, @12:54PM (2 children)
I have a plan. I'm going to invite all of them to a festival on Komodo Island . . . the dragons will be quite festive!
(Score: 2) by Azuma Hazuki on Sunday March 17 2019, @07:02PM
Watch out for that freaking go-karting bandicoot and his friends when you do.
I am "that girl" your mother warned you about...
(Score: 0) by Anonymous Coward on Sunday March 17 2019, @09:58PM
That's not a health insurance plan, though, it won't solve your problem.
(Score: 2, Insightful) by Anonymous Coward on Sunday March 17 2019, @01:01PM (1 child)
Or making their patent portfolio public domain.
(Score: 2) by Runaway1956 on Sunday March 17 2019, @01:13PM
WINNER WINNER, CHICKEN DINNER!!
(Score: 2) by takyon on Sunday March 17 2019, @12:20PM
Martin Shkreli Points Fingers at Other Pharmaceutical Companies [soylentnews.org]
The Martin Shkreli Redemption Arc
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 0) by Anonymous Coward on Sunday March 17 2019, @01:12PM
It's like eating hot chili peppers, stings at the in and stings at the exit.
(Score: 2) by The Mighty Buzzard on Sunday March 17 2019, @02:53PM
We covered this [youtube.com] back in the 90s. It wasn't supposed to be an instruction manual though.
My rights don't end where your fear begins.
(Score: 4, Insightful) by Rosco P. Coltrane on Sunday March 17 2019, @12:21PM
go to jail. CEO of companies pushing drugs don't - and get to propose solutions without flinching. Welcome to corporate America.
(Score: 1, Insightful) by Anonymous Coward on Sunday March 17 2019, @01:52PM (18 children)
From a moral standpoint,
Making and especially marketing the drug in the first place was bad.
Making the antidote for the drug is not an antidote for the bad.
The FDA seems confused on this.
Instead of preventing the company from doing anything else in the pain arena,
they are providing encouragement them with fast track.
The only way this could be good is if the antidote is required to be free along with marketing the help reverse the damage from the original drug's marketing.
I won't hold my breath.
(Score: 1, Troll) by The Mighty Buzzard on Sunday March 17 2019, @03:02PM (17 children)
Making something that's useful if used properly and deadly if improperly used by idiots is immoral? Guess we need to send Stihl, Ford, most everyone else who's ever marketed a product to the woodshed too then. Seriously, this is just Darwin skimming monumental stupidity out of the gene pool.
My rights don't end where your fear begins.
(Score: 0) by Anonymous Coward on Sunday March 17 2019, @03:33PM (14 children)
If Ford had sold his first cars without brakes, waited ten years for enough people to die, and only then started selling brakes as add-ons for twice the price of the car itself, then yes, that's immoral.
(Score: 3, Interesting) by bzipitidoo on Sunday March 17 2019, @03:58PM
While we're on the car analogies, this action is like the tire shop inventing and stocking up on run flat tires in the midst of a plan to spread bags of nails on nearby roads.
This situation calls for some strongarm negotiations. Like, maybe Purdue should release this antidote to the public domain, in exchange for reduced damages and jail time for having precipitated an opioid addiction epidemic. Antidotes aren't enough to make up for what they did, but they are of some value, and we don't want to discourage their creation. All this is presuming that Purdue really did come up with this antidote themselves, and didn't mooch it off the discoveries of a public university, as happens so often in this industry.
(Score: 2, Disagree) by The Mighty Buzzard on Sunday March 17 2019, @04:04PM (10 children)
It's not people using the drug properly and as prescribed that are overdosing. It's the idiots who use it improperly, know they're using it improperly, know it's dangerous as fuck to do so, and predictably overdose. You're essentially saying that tidepods need to come with a "for external use only" disclaimer.
My rights don't end where your fear begins.
(Score: 4, Insightful) by Whoever on Sunday March 17 2019, @06:01PM (3 children)
No, its the people who used the drug, as prescribed by their doctor, but got addicted anyway. Then overdosed.
The company pled guilty to "misbranding" -- failing to correctly disclose the risks of addiction.
This company paid doctors with the expectation that the doctors would prescribe their drugs, lied about the risk of addiction and now hope to profit from the addiction.
Why am I not surprised that TMB is once again blaming the victims, while asserting the rights of companies to make illegal profits?
(Score: 1, Troll) by The Mighty Buzzard on Sunday March 17 2019, @10:44PM (2 children)
Their actions, their responsibility. You can't overdose taking them as prescribed unless your doctor fucked up bad, so it was your choice. And pretty much all opiates are addictive and anyone who's even heard the word opiate knows this.
My rights don't end where your fear begins.
(Score: 2) by Whoever on Sunday March 17 2019, @11:08PM (1 child)
No, but you can get addicted, and many people did. The overdose results from the addiction.
You expect people who are in a lot of pain to refuse the drugs that the doctor is prescribing? Really? Yes, some people will, but most will assume that the doctor's advice is safe.
(Score: 2) by The Mighty Buzzard on Sunday March 17 2019, @11:50PM
Bullshit. Overdosing isn't addiction maintenance, it's going overboard while pleasure seeking.
If they're prescribing something you know to be both dangerous and addictive? Fuck yes I do. Unless you've been committed or are comatose, you and only you are in charge of your healthcare decisions.
My rights don't end where your fear begins.
(Score: 2) by sjames on Sunday March 17 2019, @07:22PM (5 children)
No, just that Tide Pods should never be advertised as a perfect sauce to get your kids to eat their vegetables.
(Score: 2) by The Mighty Buzzard on Sunday March 17 2019, @10:45PM (4 children)
If you're stupid enough to think an opiate isn't addictive and dangerous to abuse, you're really not any smarter than people who eat Tide Pods.
My rights don't end where your fear begins.
(Score: 2) by sjames on Monday March 18 2019, @07:06AM (3 children)
They fooled quite a few doctors. I'll leave you to your conclusions.
(Score: 2) by The Mighty Buzzard on Monday March 18 2019, @11:42AM (2 children)
Yet more proof that education doesn't mean you're not occasionally a dumbass.
My rights don't end where your fear begins.
(Score: 1, Insightful) by Anonymous Coward on Monday March 18 2019, @02:01PM (1 child)
It's sad when people blame others for trusting and don't blame those who abused the trust.
(Score: 2) by sjames on Monday March 18 2019, @06:46PM
Agreed.
(Score: 1) by Ethanol-fueled on Sunday March 17 2019, @09:03PM (1 child)
Ford, were he to still be alive, would have quite a few interesting and very correct things to say about the owners of Purdue Pharma.
(Score: 0) by Anonymous Coward on Sunday March 17 2019, @09:20PM
You mean some nasty anti-semitic shit about jews poisoning wells or similar?
Why am I not surprised this is you, Eth?
(Score: 2) by HiThere on Sunday March 17 2019, @04:53PM
The drug, if properly used, *may* be preferable to alternatives. Perhaps. But the marketing lied about the addictive potential, and bribed doctors to over-prescribe it. The bribe was so that the doctors wouldn't question how safe the drug was, and so that they would prefer it over alternatives.
FWIW, I suspect the processed drug is more addictive and less effective than raw opium, but I don't think I'll try either, and certainly don't want to get addicted to either, so suspicion is all I've got.
So, yes, their actions were immoral. The top management of the company should all be tortured daily for six months, but to alleviate the "cruel" punishment aspect, they should be allowed to take all the oxy pills of their commercial formulation that they desire. Maybe make that a year. Or two. (Some people have chronic pain that no current treatment will cure.)
Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
(Score: 4, Informative) by sjames on Sunday March 17 2019, @07:20PM
The part you're missing is how they chose to market their product as having a minimal risk of addiction while knowing damned well the risk was significant. Their intent, of course was to mis-inform doctors so they would prescribe OxyContin in more marginal cases where the benefit didn't outweigh the true risk.
Add to that, evidence that the company had a no questions asked shipping policy currently under investigation.
So it's not making the drug that is the problem it's how it was sold and marketed.
(Score: 3, Interesting) by Gaaark on Sunday March 17 2019, @04:36PM
Like making tooth whiteners that strip the enamel off your teeth leaving them sensitive, then MAKING TOOTHPASTE FOR SENSITIVE TEETH!
You get the morons coming AND going.
--- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
(Score: 3, Interesting) by Azuma Hazuki on Sunday March 17 2019, @07:04PM (6 children)
If it were up to me, everyone involved in this would be stripped of all wealth and assets, and forced to work minimum wage for the rest of their lives...but first, held in a secure setting where they were administered their own drugs and thoroughly addicted to them. THEN set free. Let the Sacklers die howling in a gutter somewhere like so many innocent people their greed killed.
I am "that girl" your mother warned you about...
(Score: 1, Troll) by The Mighty Buzzard on Sunday March 17 2019, @10:47PM (3 children)
Guess that whole empathy thing is only for people you like, eh?
My rights don't end where your fear begins.
(Score: 2) by Azuma Hazuki on Monday March 18 2019, @05:37AM (2 children)
A swing and a miss! Your fallacy is the unspoken assumption that "empathy" means "lack of moral fibre and/or sense of justice." I suppose it would, to people who think like you, but that's not the case out here in the real world. And it's a sad commentary on you and the state of your mind that you think this way.
Remember, my guiding principle is karma: what goes around comes around. It's a law of physics, or metaphysics. Empathy doesn't enter into it, because it *can't,* any more than feeling sorry for someone who pitched himself off a roof will interfere with gravity.
I am "that girl" your mother warned you about...
(Score: 2) by The Mighty Buzzard on Monday March 18 2019, @11:54AM (1 child)
It also dictates you do the minimum necessary amount of horrible shit to people because of how their suffering is going to reflect in you as empathy. Not caring about that is reserved for psychopaths, not feeling it in the first place is the province of sociopaths. And karma doesn't give you a free pass on the actions you take administering someone else's karmic debt. I don't envy you your next incarnation; it's going to be extremely unpleasant.
My rights don't end where your fear begins.
(Score: 2) by Azuma Hazuki on Monday March 18 2019, @09:21PM
So you'd better dismantle the entire justice system and forget about, for example, the death penalty then. After all, "karma doesn't give you a free pass on the actions you take administering someone else's karmic debt," so all those mean nasty awful horrible judges and juries and prison builders etc are just setting themselves up for world after world of hurt, aren't they?
Buddy, if I pull this off properly, there isn't gonna *be* a "next incarnation" for me. And even if I don't manage that I've been living in such a way that I'll avoid the worst of it next time around. You're trying to turn my knowledge against me, but doing it as clumsily as a one-armed chimpanzee with a developmental disability trying to pull off aikido.
I am "that girl" your mother warned you about...
(Score: 2) by dwilson on Monday March 18 2019, @03:45AM (1 child)
You mean, let their ridiculously wealthy family deal with them, and let them live a life that's almost what they're accustomed to? Because let's not kid ourselves here, they won't end up like the usual street-addicts.
Your hearts in the right place, the implementation needs a bit of work, is all.
- D
(Score: 2) by Azuma Hazuki on Monday March 18 2019, @05:34AM
"The implementation" includes 3-9 weeks in ad-seg where this happens to them, and no help from family. With any luck they'll be yammering batshit insane by the time of release.
I am "that girl" your mother warned you about...