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posted by CoolHand on Thursday September 06 2018, @05:11PM   Printer-friendly
from the more-science-needed dept.

Dr. Steven Novella has an article on the current state of the science on kratom and its potential as a source of new medicines. He gives an overview of the current state of the scientific study that has been done on kratom so far, and concludes that it is very promising but the scientific research done on it as of now is woefully insufficient. However, recent attempts by the FDA and DEA to schedule it on the one hand, and its continuing use as an unregulated supplement on the other may serve to stifle serious scientific research.

You may never have heard about kratom (though if you're a regular reader, you probably have), but there is already a thriving market for this Southeast Asian herb, and groups dedicated to the business of selling kratom. Kratom has also come onto the radar of the FDA and DEA, who would like to regulate it (it currently is essentially unregulated, except as a supplement). This has sparked a controversy over whether and how kratom should be regulated, fueled partly by a lack of clear scientific studies.

[...] I do not think that kratom should be classified as schedule 1, which the FDA and DEA did try to do two years ago, but had to back off due to public and political backlash. Schedule 1 is for substances with abuse potential but no legitimate medical use. The problem with this categorization is that it will frustrate scientific investigation, and that is exactly what we need right now.

It may be too late because it is already widely available as an herbal supplement, but kratom should be considered an investigational new drug, and properly scientifically studied. We desperately need more options in treating pain, especially chronic pain, and any addition to our toolkit is extremely welcome.


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  • (Score: 3, Interesting) by ikanreed on Thursday September 06 2018, @06:52PM (6 children)

    by ikanreed (3164) Subscriber Badge on Thursday September 06 2018, @06:52PM (#731459) Journal

    As people have said before and again, you can't patent nature. You can patent a process to extract specific chemicals from plants, you can patent a genetically modified strain of plant, but you can't patent something that just grows in nature.

    And while I'm no expert in cannabis, being something of a boring asshole, my understanding is that the extracting of THC, the thing that is most medically useful, is really easy for laymen, and well known, thus unpatentable. Thus profit is pretty difficult.

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  • (Score: 0) by Anonymous Coward on Friday September 07 2018, @12:56AM (3 children)

    by Anonymous Coward on Friday September 07 2018, @12:56AM (#731594)
    The pharma companies make tidy profits with generic drugs just fine. There is still profit to be made from industry without innovation.
    • (Score: 2) by ikanreed on Friday September 07 2018, @02:37AM (2 children)

      by ikanreed (3164) Subscriber Badge on Friday September 07 2018, @02:37AM (#731611) Journal

      I mean, yes, you can in fact make a profit on manufacturing things with competition.

      But the big money is in being a fucking monopoly on whether certain people live or die.

      • (Score: 0) by Anonymous Coward on Friday September 07 2018, @03:08AM (1 child)

        by Anonymous Coward on Friday September 07 2018, @03:08AM (#731619)

        But how do you get such a drug patent? It's very expensive and very risky R&D to go from scientific research to clinical trials and finally to market, and the pharma companies engaged in this sort of research have to wade through potentially hundreds of dead ends to find an avenue of investigation that leads to a drug that makes it to market. I'd think that taking such huge risks warrants compensation to those who dare it, else no one would do it. The alternative is to publicly fund investigational drug research, and while that happens to some degree and is probably better and more efficient from a societal standpoint, it flies in the face of the capitalist ideology that rules the world today, so much so that would produce knee-jerk cries of "communism" in the US.

        • (Score: 2) by ikanreed on Friday September 07 2018, @01:53PM

          by ikanreed (3164) Subscriber Badge on Friday September 07 2018, @01:53PM (#731746) Journal

          Well, you can Martin Shkrelli it and negotiate a degenerification agreement with other companies.

  • (Score: 2) by stormwyrm on Friday September 07 2018, @02:59AM

    by stormwyrm (717) on Friday September 07 2018, @02:59AM (#731615) Journal

    And while I'm no expert in cannabis, being something of a boring asshole, my understanding is that the extracting of THC, the thing that is most medically useful, is really easy for laymen, and well known, thus unpatentable. Thus profit is pretty difficult.

    Frankly, if it were legal and medically useful for me, I'd rather buy THC from a reputable drug company than some street corner peddler or try to synthesise it myself. Profit isn't really hard even when you deal with unpatentable things, as long as there is a market that will buy them. As another example, morphine (invented in 1804), oxycodone (1916), hydrocodone (1920), and fentanyl (1960) all had any patents that might have covered them expire long ago, and yet the drug companies still manage to make big profits on them. Same thing with every other drug whose patents have already expired. On the other hand, doing the R&D that leads to a drug patent is very expensive and very risky, which is why the profits have to be even bigger for this to make economic sense. For every drug patent there are probably a hundred or more research dead ends that didn't find anything useful enough to bring to market, and investigating those unpromising avenues cost money.

    Putting kratom on the schedule at this stage is very much against the interests of Big Pharma. Because they are out of patent, just about anyone with a mind to can potentially make any of the older opioids. However, if the R&D division of a drug company manages to discover a new, safer painkiller from studying kratom, they'd probably get awarded a patent for it, have their new drug prescribed in preference to the older opioids, and rake in huge profits for the next twenty years or more. But that's going to become very unlikely if kratom falls under schedule, because then the R&D is going to become less economically viable.

    --
    Numquam ponenda est pluralitas sine necessitate.
  • (Score: 0) by Anonymous Coward on Friday September 07 2018, @07:21AM

    by Anonymous Coward on Friday September 07 2018, @07:21AM (#731667)
    You can also patent the process of synthesising a chemical from a plant source, like making heroin or oxycodone from opium. Developing a novel drug-release mechanism (e.g. a way for a drug that previously needed to be injected to be taken orally) is also very much patentable.