Opioids

The False Premises of the Ruling Against Johnson & Johnson

Blaming opioid makers for the "opioid crisis" may be emotionally satisfying, but the reality is more complicated.

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This week an Oklahoma judge ruled that Johnson & Johnson should pay $572 million to "abate" a "public nuisance" the company created in that state by minimizing the hazards and overselling the benefits of prescription opioids. A few months ago, a North Dakota judge rejected a very similar claim against Purdue Pharma under a nearly identical "public nuisance" statute.

The difference between those two decisions partly reflects the difference between broad and narrow understandings of "public nuisance." But the diametrically opposed rulings also pit a simple narrative of the "opioid crisis" with a clear set of villains against a more complicated story that's closer to the truth.

Ruling against Johnson & Johnson on Monday, Cleveland County District Court Judge Thad Balkman claimed the "current stage of the Opioid Crisis…still primarily involves prescription opioids." According to records collected by the U.S. Centers for Disease Control and Prevention (CDC), however, pain pills were involved in just 30 percent of opioid-related deaths in 2017. Most of those cases also involved other drugs, mainly heroin and illicit fentanyl or fentanyl analogs, which were implicated in three-quarters of opioid-related deaths.

Balkman likewise seems to have accepted at face value Oklahoma's assertion that "opioids are highly addictive." The evidence also contradicts that claim.

In 2015, according to the National Survey on Drug Use and Health, about 2 percent of Americans who took prescription opioids, including nonmedical users, qualified for a diagnosis of "opioid use disorder," a broad category that is not limited to addiction. By comparison, about 9 percent of past-year drinkers had an "alcohol use disorder."

A 2018 BMJ analysis of medical records found evidence of "opioid misuse" in 1 percent of patients who took pain pills after surgery. While studies find that misuse is more common among chronic pain patients, a 2016 New England Journal of Medicine article concluded that "rates of carefully diagnosed addiction" average less than 8 percent.

That study, which was co-authored by Nora Volkow, director of the National Institute on Drug Abuse, noted that "addiction occurs in only a small percentage of persons who are exposed to opioids—even among those with preexisting vulnerabilities." Yet Balkman deemed such statements by Johnson & Johnson "false, misleading, and deceptive."

The judge likewise faulted the company for suggesting that prescription analgesics pose a "low danger" when used for legitimate medical purposes. But according to a 2015 Pain Medicine study, the fatal overdose rate among North Carolina patients who received opioid prescriptions in 2010 was 0.02 percent.

Balkman also thought Johnson & Johnson was wrong to say opioids could be appropriate for treating chronic pain and wrong to suggest that undertreated patients might look like addicts as they desperately sought relief. Yet as South Central Judicial District Judge James Hill pointed out when he dismissed North Dakota's lawsuit against Purdue Pharma in May, the Food and Drug Administration (FDA) has endorsed both of those propositions.

Balkman views the very idea that pain is undertreated as suspect in light of the dramatic increase in opioid prescriptions since the 1990s. But inadequate pain treatment can and does coincide with widespread misuse, and the problem has been aggravated in recent years by ham-handed efforts to reduce prescriptions, as the FDA, the CDC, and the American Medical Association have recognized.

Judge Hill concluded that the link between pharmaceutical companies and opioid abuse asserted by North Dakota "depends on an extremely attenuated, multi-step, and remote causal chain." It ignores the role of regulators who establish rules for opioid use, doctors who exercise independent medical judgment in deciding when and how to prescribe these drugs, and people who choose to take pain pills for nonmedical purposes, the vast majority of whom are not bona fide pain patients.

Hill did not mention the life circumstances that make the psychoactive effects of opioids powerfully appealing to a small percentage of people who try them. Those are the real roots of the "opioid crisis," and they cannot be remedied by litigation.

© Copyright 2019 by Creators Syndicate Inc.

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  1. Repeal the Controlled Substances Act.

  2. The judge is probably conflating addiction (rare) and dependency (guaranteed).

    Dependency is a physiological symptom where neurotransmitters production and use (primarily dopamine) is altered or reduced and replaced by opioid derivatives. This occurs in all mammals, although the rate at which it occurs varies from species to species (and person to person).

    For most people dependency won’t kick in for short (under 10 days) prescriptions, and is always present in chronic patients (180+ days) and usually present after 6 weeks such that best practices in pain management is to treat cessation after 6 weeks with anti-withdrawal medication (ex: methadone).

    Many people, including doctors who don’t specialize in this, don’t understand the difference here: all chronic patients will be dependent and will need treatment at cessation, while only a few will become addicted.

    Addiction, of course, is a psychological effect only, although addicts who also have a reliable source will also become dependent. The easy way to tell them apart, of course, is to look at dosing habits. An addict will generally take as much as they can (though hoarding will also occur), while someone who is merely dependent will take their medication on schedule (assuming its an appropriate level). The really easy way to tell them apart is to hook them both up to an IV with a patient controlled morphine dispenser after first titrating based on pain levels. The patient who keeps hitting the button is doing it for the euphoria and might be addicted. The person who comes close to matching their titrated dose is not addicted.

    1. oboy another addiction tycoon.

    2. Nonsense My sister was prescribed medication STRONGER than opioids, and she had no more interest in continuing to take these drugs after taking them for therapeutic reasons. Why is it that people comment on sites such as this with ZERO medical or other kinds of knowledge?!!?

      1. WOW! I’m a Psychologist and I suffer from Neurological nerve damage to my lower extremity’s. I at times suffer thoroughly crippling pain no human should have to go through. So what’s this medication that your sister was prescribed that’s stronger than opiates?

        1. Toradol is “stronger” than morphine, in the sense that it’s both as strong as morphine, a much more potent anti-inflammatory drug (which will likely help with your nerve damage, assuming it’s at the L5S1 nerve root), is not cross sensitive with any opiates, doesn’t cause euphoria, and has effectively no cognitive side effects (most people can drive a car after taking it).

          Of course, it’ll also trash your kidneys if you take it for more than a few days, but if you don’t have renal disease and only need short term treatment it’s fantastic. That’s what I used to always ask for in the hospital with chronic pericarditis for myself, and what I prescribe any time I can (again, short term and will cause renal failure after more than a few days, so useless for most chronic pain patients). If you take any NSAIDs regularly though, you’re not a good candidate for it.

    3. “The judge is probably conflating addiction (rare) and dependency (guaranteed).”

      Bullshit.

    4. Excellent comment.

      Long term opioid use does guarantee dependency and methadone is the best way to SLOWLY ease dependency when the pain has resolved. It’s cheap and available as a liquid in a dropper bottle so the dose can very gradually be reduced. VERY gradually, as in ~3% less per week, and the patient should never notice the discontinuance.

    5. I thoroughly disagree with the use of Methadone. It just prolongs the dependence. I won’t use it in treatment and I’ve been fortunate in my number of successes through weaning.
      I’ve excepted the fact that there are those that are simply not going to make it. Some, the weak but fortunate, are going to hit that place where death is imminent before they’ll finally reach out for help. These will fight the disease’s constant call deep within themselves until the day they die of natural causes.
      I from time to time need opiates for extreme pain and I’m watched closely by both my doctors and colleagues. I hate the stuff and wean off as quickly as possible. How anyone can claim to get off on prescription opiates is beyond me. They have psychological problems that run far deeper than opiate use and need one on one treatment.

      1. I tend to agree on not using methadone, for the reasons you describe I don’t use it in my practice, but most physicians who treat chronic pain patients get them when other treatment options have failed, so ceasing opiate treatment entirely is unlikely.

        The advantage of methadone is that it’s a) cheap and b) easily administered, so you get higher compliance at a lower cost for providers who aren’t as familiar with weaning techniques, or where resources are lower. This allows you to start with a methadone taper for all patients, then switch to another technique for those who need it.

        When cost isn’t an issue, buprenorphine is a better choice, but methadone is cheap, so there’s a trade off. And with patients who are exclusively dependent, you don’t need anything at all, as they’ll self-taper.

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  4. …however, pain pills were involved in just 30 percent of opioid-related deaths in 2017.

    Oh, only just 30%. What are we complaining about?

    1. I don’t know.

      But, I haven’t been able to figure out why my ability to acquire medication to treat my pain should rely on the positive outcomes of other patients’ misuse of similar products…

      1. Take the Napster case*. They’re a common carrier just like the phone company…except that 99.99999% of the traffic on Napster was copyright infringement. If phone lines were used almost exclusively for illegal activity, the phone companies would be sued into oblivion, too.

        Justice is blind, but it ain’t stupid.

        * Please don’t get wrapped around the axle about copyright infringement. I’m not saying the laws are right.

        1. I don’t think your Napster analogy fits here. You’re basically saying we have to be stricter on who can purchase songs because some people pirate songs.

          I don’t think 30% is that high. The article also said most of the cases involved other drugs.

          1. “…who can purchase…”

            No, I’d say he’s talking more about the purveyor, not the purchaser.

        2. A couple of things:
          1. The vast majority of opioids (and other scheduled controlled substances) are NOT prescribed or used illegaly nor are they abused or does their use result in patients’ deaths.

          2. Copyright infringement violates a third party’s rights to intellectual property,* (i.e. Napster involved: Napster, the IP/Copyrhight holder, and the downloaders/uploaders). Opioid prescription has no direct effect on third parties (i.e. unless someone files a suit, the prescriber isn’t hurt, neither is the pharma company, only the abuser/addict).

          3. In this case, the entire PREMISE of doctors, pharmacists, and pharmacuticals is to treat PATIENTS. You can’t justify denying a large swath of people treatment (while allowing the treatment to remain legal) because SOME idiots are going to unintentionally (or in some cases, intentionally) off themselves with hydrocodone…(in the case of Napster, the vast majority of files being shared could be acquired from other “legitimate” sources, the same can’t really be said about scheduled drugs, especially sense the gov’t has a monopoly on regulation and all the alternatives have been largely illegal for nearly a century).

          *Obviously, some people feel differently, and strongly about the idea of IP.

    2. Do you understand the difference between “30% of deaths involved pills” and “30% of pill users died”?

    3. And of that 30% as much as 95% of them include *other* drugs. It’s just not happening in the numbers that are being pushed.

      America is not the only country that had greatly increased the use of opioid pain pills, yet no other country is having the same problems we are.

      This whole idea of taking pain pills for a week and you’re an addict for the rest of your life is BS.

      1. Well, no. It’s rare, but some people can become addicted after only a few uses. Of course that’s not an opiate thing, that’s a personal problem. The people who will get addicted to any drug after only a few uses will get addicted to any drug after only a few uses, opiates, alcohol, caffeine, anything.

        It’s also genetic, which is why the best way to know you should never drink is if your parent and grandparents abused alcohol, because you probably inherited the gene for addiction too.

        See President Trumps comments about not drinking as an example.

  5. It reminds me of the approach taken by gun controllers: claim to “fix” the problem by punishing those who aren’t doing anything wrong.

    Government is just the name for things we do together, like punishing the innocent.

    1. This isn’t a case about punishing a doctor or patient. It’s about a company knowingly under-reporting the known hazards of a product they sell. I’m NOT saying I agree with the ruling. And yes, I get that this may have a chilling effect on patients who need opioids. But let’s not mis-characterize what’s happening.

      1. It’s not a mis-characterization at all. If patients who legitimately need medicine have trouble getting it, they’re being punished. It doesn’t matter what the claimed intentions of the government are.

        Judge a policy by the incentives it creates, not the claimed intentions of its creator.

        1. Hear, hear.

          I’m a chronic pain patient and have had opioids available on an as-needed basis for over 30 years. I can take them for days if it flares and not touch one for weeks when it doesn’t.

          My regular doctor used to write me a prescription twice a year when I went in for regular checkups. Now I have to go to a pain specialist, with an additional co-pay and they want me in every month plus extra tests.

      2. “It’s about a company knowingly under-reporting the known hazards of a product they sell.”

        Except that the root cause of the opioid “crisis” is that the government made them nearly impossible for people to get legally, resulting in people going to the black market. Look at the rulings issued by the federal government that warned doctors against prescribing more than certain amounts and you see the uptick in overdoses begin there.

        Circa 2000, millions of americans were using opioids to treat pain, and sometimes to feed an addiction. This isn’t great, but at least they were doing this in consultation with their doctor. By targeting doctors, the federal government removed the one person from this transaction who had a vested interest and training in the user’s health.

        If J&J’s misleading marketing is a public nuisance, then the federal government’s actions are a much worse crime.

        1. “If J&J’s misleading marketing is a public nuisance, then the federal government’s actions are a much worse crime.”

          This. But I’m not sure people recognize exactly what the government’s actions really entail.

          The guy selling chef’s knives hypes their sharpness and ability to cut. It is presumed that any liability for misuse falls upon the end user – he warned you it could cut.

          Meanwhile the net effect of the government – via controlled substance prescribing/dispensing law, FDA marketing restrictions, etc. is to deny the end user any sort of agency or responsibility. (That prescribers/dispensers have largely been insulated is likewise a problem.)

          And not to pretend that drug manufacturers/marketers haven’t been all too happy to play along being thrown into that particular briar patch. Statist will be fine with the addition of higher liability for the benefits of regulatory capture (progressive fascism if their ever was) but libertarians should be appalled by the compound error.

      3. “This isn’t a case about punishing a doctor or patient. It’s about a company knowingly under-reporting the known hazards of a product they sell.”

        Bullshit.

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  7. Fuck these assholes (Oklahoma judge schmutz head). I tore my ACL and MCL four weeks ago and I was in extreme pain that day and the first night. I went to the ER and the doctor told me to take some Advil. I told him it I already took 4 of them and they didn’t do shit, and then it took an act of God to get him to write me a script for four Percocet. I need pain pills about once a decade, like when I shred my knee, or get my appendix taken out, but now it appears you need first degree burns over 80% of you body to get anything stronger than Advil.

    1. Ten years ago my Mother was suffering chronic pain from botched knee replacement surgery, and she went through similar bullshit. She was given a “month’s supply” of pain medication, which only lasted about 25 days. The rest of the month she would be weeping in agony. Fuck these assholes with a rusty chainsaw.

  8. I wonder how this ruling might affect the suits against gun manufactures

  9. What it comes down to is, do you buy in to the Drug War narrative? If you do, you are probably inclined to see the greater proportion ion what the government(s) does in its name as justified. If, on the other hand, you resent thee cost of drug law enforcement, and the erosion of civil liberties that it entails, then you are probably inclined to see what the government does as scrambling to cover their collective butts when some as[ect off their policy starts to wobble.

    At this point I’m not clear on whether the ‘opioid crisis’ is an artifact of the usual progression from on popular street drug to the next as each generation reacts to what they saw the las generation of addicts doing, or something that the government created by its ham-handed handling of almost everything connected to drug use. Probably a bit on ‘one from column A and two from column B’.

    I strongly suspect that, whatever else this ruling does, it will greatly complicate the lives of people with chronic pain. And that, for me, is the bottom line; anything the government does in the name of The Drug War that causes even one person to be unable to get the drugs he needs to alleviate chronic debilitating pain is barbaric bullshit.

    The Drug War must end.

    1. “The Drug War that causes even one person to be unable to get the drugs he needs to alleviate chronic debilitating pain”

      How else is the FDA going to pull a million dollars per drug testing if they can’t lobby for a whole slew of regulations and scare the living daylights out of the people? Desire goes only so far with buyers. You have to literally scare the pants off of them to rip them completely off.

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  11. The argument that Johnson & Johnson under-reported the risks of addiction reminds me of the nonsense that was peddled about tobacco. Back when my Dad was a kid (the ’20s and ’30s) cigarettes were often referred to as “coffin nails”, but gee nobody knew smoking was hazardous to health? Come on.

    Likewise I’ve known all my life that drugs–especially but not limited to painkillers–are potentially addictive. But gee, nobody knew? Really?

    1. The utter bullshit peddled by the anti-smoking crusaders has annoyed me for decades. These fools appear to believe that if they just don’t actually quite BAN tobacco they will escape the negative aspects of Prohibition. Ha!,

      They have already managed to make cigarette smoking ‘cool’ again, something that I wouldn’t have believed if I hadn’t seen it. The degree of their lies approaches the degree of the lies told about marijuana in the 1970’s by committed (as in ‘should be’) drug warriors.

      Smoking is a vice. It ain’t good for you. But this business of ‘lets hound all the vices we don’t partake of personally out of society’ is idiocy. Especially when coupled with the impulse to persecute anyone who criticizes the vices they defend.

      1. Vaping is now going down the same path. All kinds of ‘problems’ are being attributed to vaping that likely have no connection.

        We are a nation of scolds and busybodies!

    2. Any doctor who believed that an opioid drug was free of dependence and addictive risks should never have passed med school. Any patient who knows anything about what they’re taking knows the same.

      I’m a 30+ year long chronic pain patient and when Oxy first came out I ran into this guy who was just raving about how good it was. That, in and of itself, prevented me from even asking my doctor about it. I don’t want meds that mess with my head. I won’t take mine unless I’m hurting bad enough that I can’t think straight anyway. But when I need them …. Missing part of a shoulder blade and the bottom of my back all fused and bolted together. I had gotten as high as methadone before the back surgery, but after a few months of recovery from that, I went back down to hydrocodone and have only increased that once.

      I used to be able to get them from my regular Dr on my normal checkups. Now I have to go to specialists with additional and higher co-pays and they want to see me every month.

  12. an Oklahoma judge ruled that Johnson & Johnson should pay $572 million to “abate” a “public nuisance”

    OK, now go after Microsoft.

    1. OK, now go after Microsoft.”

      they did that and Microsoft placated them by increasing their Lobbying dollars, J&J obviously weren’t paying, I mean Lobbying enough congresscritters

    2. How much of that $572 million will go to the victims’ families? I doubt that those families will see even a dime. This is just another revenue source for the state of Oklahoma.

  13. From True Grit, one of the best legal and movie lines ever:
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    Ned Pepper:
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  14. “At the root of this crisis was Johnson & Johnson, a company that literally created the poppy that became the source of the opioid crisis,” the state charged.

    Ummm no.

    1. J&J is incorporated in Afghanistan?

  15. Excellent article

  16. The real harm in this ruling is the way it is telling all druggies, burglaries, murderers and crooks, “Your a victim!”

    “Your a stupid sheep that cannot think. Any crime you commit or horrible consequence you end up in; in response to the terrible choices you have made and/or life you’ve chosen to live is — SOMEONE ELSE’S FAULT!”

    What do all of the worse criminals proclaim in prison again? Oh yeah, “I’m innocent!, I had to take those pills, rob that bank, steal that car, rape that child, murder that neighbor… I’m a VICTIM!”

  17. Akin to giving Big Pharma a parking ticket. Whatever measly fines they pay will be recovered tenfold with rising drugs costs. Nothing will change. We have millions of people on drugs (opioids) and yet we never discover the root causes of pain. The medical mafia is never about cure, only dishing out as many drugs as possible as fast as they can sell them. They are the enabler, but somewhere along the line the people actually taking the drugs have to be responsible.

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