Stories
Slash Boxes
Comments

SoylentNews is people

SoylentNews is powered by your submissions, so send in your scoop. Only 19 submissions in the queue.
posted by martyb on Sunday November 04 2018, @04:33AM   Printer-friendly
from the need-more-opioids-to-fight-the-opioid-epidemic dept.

FDA approves powerful new opioid in 'terrible' decision

The Food and Drug Administration approved a powerful new opioid Friday, despite strong criticism and accusations that it bypassed its own advisory process to do it.

The new drug, Dsuvia, is a tablet that goes under the tongue. It is designed for use in the battlefield and in other emergency situations to treat intense, acute pain.

Known generically as sufentanil, it's a new formulation of a drug currently given intravenously. Critics say it will be incredibly easy for health workers to pocket and divert the drug to the illicit drug market and because it is so small and concentrated, it will likely kill people who overdose on it.

"This is a dangerous, reckless move," said Dr. Sidney Wolfe senior adviser of Public Citizen's Health Research Group. He questions whether there's need for yet another synthetic opioid when the U.S. is in the throes of an opioid overdose crisis.

Sufentanil is described as 5 to 10 times more potent than fentanyl and 500 times as potent as morphine. Carfentanil is 100 times more potent than fentanyl, but is only approved for the veterinary use of tranquilizing large animals. Sufentanil is the strongest opioid painkiller available for use in humans.

Cannabis and kratom? Exercise caution!

Also at STAT News, NPR, and The Hill.

See also: People on front lines of epidemic fear powerful new drug Dsuvia

Related:


Original Submission

 
This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
(1)
  • (Score: 5, Insightful) by Anonymous Coward on Sunday November 04 2018, @04:36AM (22 children)

    by Anonymous Coward on Sunday November 04 2018, @04:36AM (#757503)

    It is far more important to me that a person suffering pain is helped, rather than trying to ensure no one will take that drug for enjoyment.

    • (Score: 1, Insightful) by Anonymous Coward on Sunday November 04 2018, @05:10AM (20 children)

      by Anonymous Coward on Sunday November 04 2018, @05:10AM (#757509)

      What the drug warriors will never understand is that the best way to prevent deaths due to overdose is to allow the drug to be sold regardless of prescription status. Some people might use it recreationally. Get over it. Their lives will be saved by packaging regulations that cannot be enforced on a black market.

      • (Score: 0) by Anonymous Coward on Sunday November 04 2018, @06:27AM (16 children)

        by Anonymous Coward on Sunday November 04 2018, @06:27AM (#757516)

        To an extent, but nothing stops them from ingesting multiple full packages at once.

        • (Score: 5, Insightful) by deimtee on Sunday November 04 2018, @07:55AM (13 children)

          by deimtee (3272) on Sunday November 04 2018, @07:55AM (#757528) Journal

          Clearly marked commercial packages with a known standard dose will greatly reduce accidental overdoses.

          To an extent, but nothing stops them from ingesting multiple full packages at once.

          If you deliberately take a fatal dose that is not accidental, it is suicide.
          The sort of people who think you should have the right to control your own body with respect to taking drugs are also the people who are mostly ok with you having the right to end your life if you so choose. It is the difference between being a free person and being owned by society.
          Argument about this will do nothing because it is not a disagreement on fact, but on ethics.

          --
          If you cough while drinking cheap red wine it really cleans out your sinuses.
          • (Score: 1, Insightful) by Anonymous Coward on Sunday November 04 2018, @08:53AM (1 child)

            by Anonymous Coward on Sunday November 04 2018, @08:53AM (#757537)

            I don't disagree with the sentiment. Nontheless, you don't need suicidal tendencies to overdose, if someone wants a greater buzz they'll eat more of the stuff, packaging instructions be damned.

            • (Score: 5, Interesting) by takyon on Sunday November 04 2018, @09:44AM

              by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Sunday November 04 2018, @09:44AM (#757552) Journal

              When the AC mentioned packaging regulations, I assumed that the AC was referring to the drugs being pure and containing whatever is on the label.

              From this drug propaganda site comes these true fax: [drugabuse.gov]

              Even though it's supposed to be pure MDMA, Molly is just as likely to be mixed with other substances as any other drug.

              Supposedly "pure" Molly can contain ephedrine (a stimulant), dextromethorphan (a cough suppressant), ketamine, caffeine, cocaine, methamphetamine, or even bath salts. Just because it comes in crystal or powder form—instead of a pill like Ecstasy—doesn’t prove that it's pure.

              Some powder sold on the street as “Molly” doesn’t contain any MDMA at all. That’s even more dangerous, because you don’t have a clue what you’re really taking!

              If you look in the related stories in the summary, you'll find that one major problem of the opioid crisis is that heroin users are getting heroin mixed with stuff like carfentanil. It's more potent and thus a cheaper high, but a miscalculation on the dealer's part could easily cause hundreds of users to die from overdose.

              Likewise, an "acid" blotter could contain any number of similar substances rather than LSD. For example, 25C [wikipedia.org] or 25I [wikipedia.org]. The size/mass of a soaked blotter does not give the user any clue to the amount and kind of active substance that is contained within. The typical dosage of different substances could be an order of magnitude or more apart. Examples:

              https://www.erowid.org/chemicals/lsd/lsd_dose.shtml [erowid.org]
              https://www.erowid.org/chemicals/2ci_nbome/2ci_nbome_dose.shtml [erowid.org]

              Even though the common dose for 25I could be ten times that of LSD, it will fit on the same blotter paper just fine.

              In the scenario where we legalize all recreational drugs, you could buy your drugs from companies that have to comply with health, safety, and labeling regulations. So instead of getting heroin, meth, MDMA, etc. of varying levels of purity (sometimes 0%), you could get pharmaceutical-grade products that are exactly what they claim to be.

              An interim step would be to expand drug testing at places like music festivals. These operations could be given grants or explicit legal protections. Or permanent walk-in labs could be set up, at which anybody could bring in drugs for testing, no questions asked.

              Festival drug-testing shows a way to reduce harm [economist.com]
              First ever pill-testing trial at Australian music festival [theguardian.com]
              https://dancesafe.org/ [dancesafe.org]

              Another packaging regulation: organic certification and enforcement of bans on certain pesticides/chemicals. For decades, the vast majority of cannabis has been illicitly grown. Can you trust some illegal grower (who you haven't met, you only see a dealer) to not use banned and potentially dangerous pesticides?

              Today, a lot of cannabis in the U.S. is now quasi-legally grown (and it can be illegally shipped from a "legal cannabis" state to other states, retaining labeling info). It's more clear what strain of cannabis you're getting, where it's coming from, etc. And some companies are touting their "organic cannabis" and best practices:

              https://www.coloradopotguide.com/colorado-marijuana-blog/article/what-organic-cannabis-means-for-the-marijuana-industry/ [coloradopotguide.com]

              As it stands, there are no pesticides that are permissible for both smokable and edible products combined, so cultivation must involve 100 percent organic techniques at all times in order to be of organic quality. This usually takes place through soil supplementation which includes things like worm castings, compost, castings, bat guano, perlite, fish emulsions or peat moss.

              Though these products will never officially be “organic” until it becomes federally legal, ancillary companies like the Cannabis Certification Counsel have come along to provide unbiased certification for cannabis products that have been “organically grown and fairly produced”.

              Though cannabis products cannot be certified organic, they can absolutely be cultivated organically, thus removing concern regarding contaminants like pesticides or heavy metals. According to a Steep Hill report [prnewswire.com], 84 percent of California cannabis contains pesticides, the bulk of which being Myclobutanil, a fungicide primarily used on grapes.

              Though the product has been deemed safe for use on grapes that can be washed clean, the same cannot be said for cannabis. To make matters worse, smoking pesticides can release dangerous toxins like hydrogen cyanide, carbon monoxide, carbon dioxide, hydrogen chloride and more. If smoking pesticides off of cannabis flower is this bad, imagine how dangerous non-organic cannabis concentrates can be.

              Decades ago, who knows what kind of crap was on the weed that people were smoking? Today and further into the future, you'll be able to obtain "clean" cannabis.

              --
              [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
          • (Score: 2) by stretch611 on Sunday November 04 2018, @01:11PM (10 children)

            by stretch611 (6199) on Sunday November 04 2018, @01:11PM (#757588)

            Clearly marked commercial packages with a known standard dose will greatly reduce accidental overdoses.

            To an extent, but nothing stops them from ingesting multiple full packages at once.

            If you deliberately take a fatal dose that is not accidental, it is suicide.

            The problem is that painkillers in tablets are generally provided along with other ingredients designed to force the drug to be slowly dissolved over time. This allows the painkiller to last over a few hours.

            However, people that want to take them for recreation are interested in getting a high and the intentional extended release period is counter productive to getting the full effect of a single dose all at once. They are forced to either taking multiple doses at once or crush the pills into a fine powder to release the active ingredients all at once. Either is very dangerous.

            So, even if commercial packages were legally available, people looking to get high are still forced to follow risky behavior in order to get their fix. While I would not say it is a smart thing for them to do, I would not characterize it as suicide either.

            --
            Now with 5 covid vaccine shots/boosters altering my DNA :P
            • (Score: 3, Interesting) by deimtee on Sunday November 04 2018, @02:12PM (7 children)

              by deimtee (3272) on Sunday November 04 2018, @02:12PM (#757610) Journal

              You are still thinking within the "drugs are bad mmmkay" paradigm and not following this to its logical conclusion. Legally available drugs for getting high would not have the time delay built into therapeutic drugs. You would buy whatever variant you wanted.

              Almost every bad effect of illegal drugs can be traced to the fact that they are illegal:
              Drug crimes - a tautology. they are illegal because they are illegal.
              Property crime - drugs are insanely expensive due to being illegal. There is no way most habitual users can legally pay for them.
              Violence - mostly goes along with the desperation that drives addicts into property crime.
              Prostitution - One of the few ways to actually earn enough money to pay for illegal drugs.
              Gang violence - drugs are a huge illicit revenue source. Of course criminal gangs will move in and fight over it.
              Overdoses - almost entirely due to shoddy quality control.
              Drugged driving - should be handled the same way you handle drunk-driving.

              --
              If you cough while drinking cheap red wine it really cleans out your sinuses.
              • (Score: 2) by takyon on Sunday November 04 2018, @03:37PM (2 children)

                by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Sunday November 04 2018, @03:37PM (#757637) Journal

                Property crime - drugs are insanely expensive due to being illegal. There is no way most habitual users can legally pay for them.

                Close. Some drugs are relatively cheap. But they could make one unemployable, either due to drug testing or turning the user into a wreck.

                --
                [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
                • (Score: 4, Informative) by deimtee on Sunday November 04 2018, @04:18PM (1 child)

                  by deimtee (3272) on Sunday November 04 2018, @04:18PM (#757649) Journal

                  Heroin is about as cheap and easy to make as aspirin. I can buy 36 x 500mg aspirin tablets for 99 cents.
                  If you are going to sit around on welfare and get wasted every day, I would rather you do it without having to break into houses or mug people in the park.

                  --
                  If you cough while drinking cheap red wine it really cleans out your sinuses.
                  • (Score: 0) by Anonymous Coward on Monday November 05 2018, @12:06AM

                    by Anonymous Coward on Monday November 05 2018, @12:06AM (#757787)

                    It wasn't too long agobI was buying a bottle of 200 at that price. Brand name: "Assured". At Dollar Tree.

              • (Score: -1, Flamebait) by Anonymous Coward on Sunday November 04 2018, @04:16PM (1 child)

                by Anonymous Coward on Sunday November 04 2018, @04:16PM (#757647)

                Sitting in the park shitting yourself after taking drugs. Doesn't matter if the drug is legal or not. Still there. Still have shit running down your leg. Stupid junkie.

                • (Score: 0) by Anonymous Coward on Monday November 05 2018, @03:29AM

                  by Anonymous Coward on Monday November 05 2018, @03:29AM (#757838)

                  Too close to the truth. People don't want to hear the truth.

              • (Score: 1, Interesting) by Anonymous Coward on Sunday November 04 2018, @07:38PM (1 child)

                by Anonymous Coward on Sunday November 04 2018, @07:38PM (#757705)

                This! The best drug law (the only one that works) is the Pure Food & Drug Act of 1907. It required proper labeling and drove the medicine show con artists out of business. It is not a criminal law. The black market for drugs causes all sorts of bad consequences. The black market for any drug must go. How? Lower the price and profits. Legalize. Law enforcement is a price-support mechanism. They love their little war.

                Search for "whitebread speech", best history of drug laws I've seen anywhere.

            • (Score: 2) by sjames on Sunday November 04 2018, @05:39PM

              by sjames (2882) on Sunday November 04 2018, @05:39PM (#757675) Journal

              The thing is, they're going to do that with whatever form of opioid they can obtain. That may either be an exact and well regulated dose or some random powder of unpredictable strength.

              Neither is safe, but the latter is vastly more likely to kill them than the former.

              Making the former legally available won't prevent all deaths but leaving them with only the latter will cause more deaths.

            • (Score: 3, Insightful) by EETech1 on Sunday November 04 2018, @07:29PM

              by EETech1 (957) on Sunday November 04 2018, @07:29PM (#757703)

              If I was to crush up and snort a couple of oxycodone pills, I know exactly what I'm in for.

              If I was to crush up and snort a bindle of heroin I bought from a junkie, not so much...

              The measured dose is what allows you to safely enjoy your vise, and the lack of crime involved with getting it from the pharmacy will go a long way towards not destroying lives, both physically, and financially.

              Drugs are a slippery slope, but some people like to ride it.

              But it's no different than any other dangerous recreational activity, if you give them the tools to do it safely.

              Some people wanna climb rocks, some people wanna smoke rocks.

              Why is it ok to be "addicted" to rock climbing, searching for higher and higher peaks to conquer?

              You're literally one mistake from death, risking it all for the thrill of it.
              Not thinking about anyone but yourself, and what you want to do.

              If someone wants to tweak out on amphetamines, why should their passion for smoking rocks, and taking the same risk of death as the rock climber be treated any differently? Why do we not allow them the gear to do it safely?

              Why do we put one of them in jail? Both the climber and the smoker just wanna get high, but we treat them so differently.

        • (Score: 3, Insightful) by sjames on Sunday November 04 2018, @05:23PM

          by sjames (2882) on Sunday November 04 2018, @05:23PM (#757671) Journal

          Nothing stops them from huffing gasoline until dead either.

          One thing that might help is if they could get actual help with their addiction without having to admit to both past felonies and a great likelihood of future felonies first. In other words, treat it as the medical problem that it is, not a legal problem.

        • (Score: 3, Insightful) by NotSanguine on Sunday November 04 2018, @11:01PM

          by NotSanguine (285) <NotSanguineNO@SPAMSoylentNews.Org> on Sunday November 04 2018, @11:01PM (#757769) Homepage Journal

          The Darwin Awards [darwinawards.com]

          Freedom isn't necessarily safe. Nor is it necessarily easy.

          If someone feels the need to ingest lethal doses of *anything*, who are we to stop them?

          People have been documented as using mind-altering substances for a variety of reasons for millennia. And it wouldn't surprise me in the least if we'd been doing so for tens of millennia.

          The "drug war" is a mechanism for funding police and keeping a lid on various minorities. This has been repeatedly documented by study after study.

          All drugs should be legally available, with strict quality and dosage control.

          With all the money we save (billions every year), we can provide treatment to every single person with abuse problems and still have lots left over.

          But no. We have to choose the most dangerous (in terms of outcomes and violence) path, that's least likely to solve the problem and keep doubling down on it. Sigh.

          --
          No, no, you're not thinking; you're just being logical. --Niels Bohr
      • (Score: 5, Interesting) by takyon on Sunday November 04 2018, @06:30AM (1 child)

        by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Sunday November 04 2018, @06:30AM (#757517) Journal

        The Trump administration has pretty much failed in this regard. Lackluster responses to the opioid crisis with no consideration of legalizing everything, or at least using cannabis to counter opioids [soylentnews.org]. Jeff Sessions may be one of the biggest obstacles to trying a new approach, but has made himself politically unfireable. A neat trick.

        Democrats seem to be finally pushing for cannabis legalization, but talk is very cheap when they don't control the Presidency, House, or Senate. They still have plenty of time to do a 180° or foot drag later. Even if they do reschedule cannabis, there is no way they would abolish/reform the DEA or Controlled Substances Act. "Legalize everything" is a fringe idea, even if it makes sense. Democrats would be afraid of alienating voters or looking weak on crime.

        That's all before we consider how the alcohol and pharmaceutical industries may fight to preserve the status quo.

        --
        [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
      • (Score: 0) by Anonymous Coward on Sunday November 04 2018, @06:26PM

        by Anonymous Coward on Sunday November 04 2018, @06:26PM (#757691)

        The drug warriors don't care about preventing deaths. That's just their excuse for employment. Drug control is a government jobs program.

    • (Score: 3, Interesting) by chewbacon on Monday November 05 2018, @02:13AM

      by chewbacon (1032) on Monday November 05 2018, @02:13AM (#757813)

      I did my BSN with about 6-7 years of nursing experience under my belt. I wrote a paper to argue against many of the ER nurses attitudes that painted a disproportionate number of patients complaining of pain as drug seekers. My research suggested it's far better to give the seekers drug, giving them the benefit of a doubt and being wrong, than letting someone go in pain. And the number of drug seekers in the ER is pretty damn low when you account addicts that will get it on the streets, steal it from family, or abuse their own supply and manipulate their doctor to prescribing more.

      So in the acute setting, it's not the time to weigh out if a patient is seeking drugs or in pain. Most of the time, it will be the latter. And if it is the fore, their addiction will need therapy, detox, etc. which they will not get in an acute care setting.

  • (Score: 2, Insightful) by Anonymous Coward on Sunday November 04 2018, @04:52AM (3 children)

    by Anonymous Coward on Sunday November 04 2018, @04:52AM (#757506)
    ...from that honest to goodness Big Pharma shill [respectfulinsolence.com] in charge of the FDA today. Talk about the fox guarding the henhouse, but that seems to be depressingly common in this present administration.
    • (Score: 3, Informative) by stretch611 on Sunday November 04 2018, @01:18PM

      by stretch611 (6199) on Sunday November 04 2018, @01:18PM (#757591)

      It makes you wonder where the data would lead if you follow the money...

      From NPR [npr.org]:

      Though the advisory committee ultimately voted in favor of the drug, Public Citizen contends the FDA sought to "tilt" the vote's outcome toward approval. Brown, the committee chief, who has been outspoken against certain opioids in the past, says he was unable to attend the advisory committee meeting on Oct. 12 because of a scheduling conflict that he had informed the FDA about months in advance.
      Brown says the FDA decided to hold the meeting anyway — without him.

      And...

      The October meeting also left out most members of another FDA committee — the Drug Safety and Risk Management Advisory Committee — who are often included in regulatory discussions of new opioid drugs. Public Citizen says members of that committee were not invited to attend.

      --
      Now with 5 covid vaccine shots/boosters altering my DNA :P
    • (Score: 0) by Anonymous Coward on Sunday November 04 2018, @01:43PM

      by Anonymous Coward on Sunday November 04 2018, @01:43PM (#757600)

      No, expectations are low, but not this low.

      This seems a very specialized drug with use only in a few authorized instances. Not much profit there.

      So why would a profit driven drug company choose this path?
      Perhaps the cash flow expectations inside the company included expected unauthorized uses.

      It's one thing for a health care company to do their fiducial duty choose max profit over max health.
      (Like making something a chronic condition instead of a cured condition.)

      It's a whole 'nuther level to choose a profit path which has a negative health benefit.
      (That's game plan more expected from nicotine delivery systems. Those folks are relatively honest about what they do.)

      I have no clue if this is the case, but given what opioids have already done and a President interested in the area, it seems strange that his administration would head this way.

    • (Score: 1, Flamebait) by Rich26189 on Sunday November 04 2018, @03:19PM

      by Rich26189 (1377) on Sunday November 04 2018, @03:19PM (#757633)

      "Score: 2, Insightful"?

      depressingly common in this present administration.

      Maybe "1, redundant". Has this never happened prior to Jan. 2017?

  • (Score: 1, Insightful) by Anonymous Coward on Sunday November 04 2018, @11:04AM (2 children)

    by Anonymous Coward on Sunday November 04 2018, @11:04AM (#757571)

    I have to almost beg for painkillers when i need them perhaps once every 2 years as my doctor is afraid of the feds, and have to almost give DNA to get Pseudoephedrine from the local store.

    • (Score: 0) by Anonymous Coward on Sunday November 04 2018, @06:34PM (1 child)

      by Anonymous Coward on Sunday November 04 2018, @06:34PM (#757694)

      Of course. Some people who desperately need painkillers, who now can't get them, will turn to street drugs. Many of those people will be caught, tried, sentenced, and perhaps even locked up.

      There is a vast police system, court system, probation system, and jail system. To keep having a "need" to exist, these systems need bodies to process. Your body will do just as well as any other. These systems are government jobs programs.

      “Did you really think we want those laws observed?" said Dr. Ferris. "We want them to be broken. You'd better get it straight that it's not a bunch of boy scouts you're up against... We're after power and we mean it... There's no way to rule innocent men. The only power any government has is the power to crack down on criminals. Well, when there aren't enough criminals one makes them. One declares so many things to be a crime that it becomes impossible for men to live without breaking laws. Who wants a nation of law-abiding citizens? What's there in that for anyone?

      -- Ayn Rand, Atlas Shrugged

      • (Score: 0) by Anonymous Coward on Sunday November 04 2018, @08:35PM

        by Anonymous Coward on Sunday November 04 2018, @08:35PM (#757720)

        Plus, the people who turn to the black market are unable to be certain of the potency or composition of the product they purchase. So they become at risk for overdose when they were just looking for pain relief. If capitalism could solve this problem (i.e. Ayn Rand), black markets wouldn't have problems with product quality that lead to overdose deaths. An organized working class democratically controlling the means of production and governance is the only social force can guarantee safe access to quality pain relief drugs.

        The manufacture of criminals, such as with prohibition laws, is an artifact of capitalism, and it serves the interests of the capitalist elite who run for-profit prisons, among other industries. Atlas Shrugged is nothing more than political fantasy. Real political change requires a scientific study of history.

  • (Score: 3, Insightful) by MichaelDavidCrawford on Sunday November 04 2018, @06:01PM

    by MichaelDavidCrawford (2339) Subscriber Badge <mdcrawford@gmail.com> on Sunday November 04 2018, @06:01PM (#757682) Homepage Journal

    If there's a campaign donation, then there's a need.

    --
    Yes I Have No Bananas. [gofundme.com]
(1)