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FDA Commissioner Scott Gottlieb has released a new statement denouncing the drug kratom. The statement says that the FDA has learned about new deaths that "involved" kratom use, additional adverse effects associated with its use have been found, and that Public Health Assessment via Structural Evaluation (PHASE) "3-D computer technology" has been used to analyze the chemical compounds in kratom:
Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.
The FDA continues to discourage the use of kratom, which it is calling an opioid.
The American Kratom Association provided a rebuttal of the FDA statement:
Nine leading scientists in substance addiction and safety wrote to White House Opioid Crisis Team Leader Kellyanne Conway and Acting DEA Administrator Robert W. Patterson requesting they disregard the FDA's latest disinformation campaign against kratom. The scientists warned that "four surveys indicate that kratom is presently serving as a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom. A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain."
[...] David Herman, Chairman of the AKA, called upon FDA Commissioner Gottlieb to pull back the curtain on the "black box voodoo computer model" that was unveiled by the FDA to justify their continued 'War on Kratom,' this time claiming their computer model conclusively shows kratom is an opioid, and therefore had to be banned.
The nine respected scientists pointed out that "kratom provides a far more favorable safety profile for consumers compared to more dangerously addictive and potentially deadly classical opioid medications." They also pointed out that the FDA's solution – to file a new drug application for kratom – made no sense because "the average time and cost of new drug development is more than 10 years and 2.5 billion dollars."
Previously: DEA Welcomes Kratom to the Schedule I List Beginning September 30
The Calm Before the Kratom Ban
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
Related: Opioid Commission Drops the Ball, Demonizes Cannabis
(Score: 5, Insightful) by julian on Monday February 12 2018, @05:50AM (22 children)
Nuts, just nuts. Even if Kratom was an opiate (botanically it is not; it's more closely related to coffee) it would be the least prone to abuse and dangerous opiate known. I suspect that the reason it's disfavored by regulators is that it's an herbal product, not a refined pharmaceutical. It can't easily be patented in the form that it's usually consumed. Regulators would rather you take vikes or OC which their donors tell them are regulated, safe, tested, and reliable.
I am not a physician. I don't know if Kratom is good for opiate withdrawal or addiction maintenance. I can check the news and the literature with a simple web search and I can't find any news of people dying from it like they are from heroin, fentanyl, or other opiates. At the same time there seems to be a lot of anecdotal evidence that it helps many people either kick their addiction or replace it with a safer one. The government isn't saying we are banning this for the moment while we study it, they're just shutting the door indefinitely since the money barrier is so high.
This is unacceptable. You have a right to the pursuit of happiness, and if that means beating your addiction with Kratom I think you should pursue that.
(Score: 2) by Rosco P. Coltrane on Monday February 12 2018, @06:07AM (4 children)
You have a right to the pursuit of happiness
Where did you get that notion? That "right" to pursue happiness you think you have is endowed by a fictional character. But last I check, he ain't the one running the government...
(Score: 3, Interesting) by Farkus888 on Monday February 12 2018, @07:41AM (1 child)
You should check out the concept of negative rights based governments. Americans have a negative rights government so if you are American you have that right.
(Score: 0) by Anonymous Coward on Monday February 12 2018, @02:17PM
Know your rights! All three of them! [youtube.com]
(Score: 0) by Anonymous Coward on Monday February 12 2018, @09:08AM
You have a right to the pursuit of happiness in the same way a greyhound has a right to pursue the mechanical rabbit during a race. Your not allowed to catch happiness and the means of pursuit will be via high taxed means.
(Score: 2) by OrugTor on Monday February 12 2018, @04:34PM
That's an interesting observation. Now, 'Creator' can be interpreted broadly - it could be the Big Bang. Anyway, a more compelling reason (IMO) to discount the 'right' is that it occurs in the Declaration and thus has no legal standing.
(Score: 3, Insightful) by Runaway1956 on Monday February 12 2018, @06:24AM (4 children)
For every action, government has an over reaction.
Fact 1: people are dying from opiate addictions.
Fact 2: kratom has been mentioned in the same discussions as opioids.
Conclusion: Opioids and kratom must be outlawed, and very strictly regulated.
Course of Action: A new War on Drugs, this time including kratom.
Results: More dead Americans - an easily replaceable resource, considering the number of illegal aliens clamoring for citizenship.
“I have become friends with many school shooters” - Tampon Tim Walz
(Score: 3, Insightful) by c0lo on Monday February 12 2018, @07:52AM
(pharma) profits shall not stop! Otherwise it's not free market, it's communism!
(large trollish grin)
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 2) by LoRdTAW on Monday February 12 2018, @02:15PM (1 child)
Americans are spoiled and demand too much pay. Foreigners are desperate and eager to work for less than the Americans. I see this as nothing but good. -PHB
(Score: 2) by Freeman on Monday February 12 2018, @05:37PM
Considering what most citizens of 1st World countries think of as "poor", you would be right. There is a Huge population of people living in extreme poverty. The issue, is that most of them are a continent away. A majority of African countries have a large population of extremely poor people. I don't see see foreigners being desperate and eager for work as a good thing. It's an unfortunate reality. The poem on the Statue of Liberty is a wonderful ideal to strive towards and perhaps we should have a bit more welcoming policy towards immigrants. The problem I see, is that we've strayed too far away from the ideals that were put into motion in the founding of the United States of America. Though, there were definitely a few things that needed ironing out, such as Slavery and the Right to Vote.
Joshua 1:9 "Be strong and of a good courage; be not afraid, neither be thou dismayed: for the Lord thy God is with thee"
(Score: 1) by nitehawk214 on Monday February 12 2018, @06:42PM
Oh yeah, and absolutely zero change in addiction rates.
"Don't you ever miss the days when you used to be nostalgic?" -Loiosh
(Score: 5, Interesting) by stormwyrm on Monday February 12 2018, @07:19AM (6 children)
There's a serious reason why herbal products are no longer used directly in today's medicine, and it has nothing to do with the fact that herbal medicines can't be patented: the amount of active ingredient in a particular herb varies greatly from plant to plant, and for many medicines the line between a therapeutic dose and a toxic one is a very fine one. Take digoxin, for instance, which is used to treat heart arrhythmias. You can get it in its natural form from the foxglove plant, but how much digoxin is available varies from one plant to the next. If you were unlucky one batch of foxglove you tried to use might have a dangerously high quantity of digoxin, and you'd kill a person if you gave a concoction like that to them.
Which is why this outright ban on kratom is even more perplexing to me. A pharmaceutical company that did research on the active ingredients in kratom could stand to make a very large amount of money if they could isolate the sources of its pharmacological action, and come up with proper drugs based on it that have reasonably well-understood effects. The "computational model" that the FDA seems to have done and used as a basis for banning it sounds like it is the equivalent of scribbling a few equations on the back of an envelope as far as pharmacological research goes. At the rate this is going it's going to be very costly for even a major drug company to do proper research of the kind needed to even establish the pharmacological usefulness of the compounds in kratom. Even though Scott Gottlieb is just about as big a pharma shill as they come [respectfulinsolence.com], I don't see how this ban benefits the pharma companies much either.
Numquam ponenda est pluralitas sine necessitate.
(Score: 3, Interesting) by LoRdTAW on Monday February 12 2018, @02:23PM (1 child)
Why spend money investigating a product that competes with your already existing, more addictive and VERY profitable product? They have nothing to lose here.
(Score: 2) by stormwyrm on Monday February 12 2018, @03:21PM
Why spend money investigating such a product? Tell me something, what is the status of the patents on oxycodone? It was discovered in 1916. Hydrocodone? Discovered in 1920. Fentanyl? Discovered in 1960. The patents for all of these opioid drugs expired long ago, meaning nobody has to pay anyone royalties to make them. The only reason why they're suddenly more profitable to the drug companies these days is largely because of an infamous letter in the New England Journal of Medicine in 1980 [bbc.com] alleging that addiction to opioids is "rare". Before this letter, doctors were much more reluctant to prescribe opioid painkillers out of concern for their addictive properties. The letter made these drugs much more profitable because it made doctors more willing to prescribe them, leading to the opioid crisis we have today. Now, if I were a big pharmaceutical company, I'd definitely want to do serious research into kratom. Given the kind of anecdotal evidence it carries, there's a reasonably good chance that there's something interesting in there, and the only way to find out is to actually do the research. If it pays off I could have a new, safer painkiller to compete with the dangerous opioids, and I would hold the patents on it. It would make my shareholders very rich indeed as the new drug would then be prescribed instead of the opioids. But if there are regulatory roadblocks to doing this kind of research, then it suddenly doesn't look like such a promising strategy. Look at how research into marijuana-derived compounds languished over the years thanks to the same sort of regulation that they're imposing on kratom today.
But then again, my thinking here is probably much more far-sighted than most of the MBAs that run Big Pharma these days. They'd be content to let R&D languish if doing so would make next quarter's numbers look slightly higher.
Numquam ponenda est pluralitas sine necessitate.
(Score: 3, Interesting) by ElizabethGreene on Monday February 12 2018, @04:56PM
>> A pharmaceutical company that did research on the active ingredients in kratom could stand to make a very large amount of money if they could isolate the sources of its pharmacological action
The same pharmaceutical company should also look at https://en.wikipedia.org/wiki/Ibogaine [wikipedia.org] . It's a psychedelic herbal that anecdotally _permanently_ turns off the physical mechanisms of Opiod addiction in 90%+ of the people that try it. It was a non-trivial risk of death in herbal form, particularly if the patient has low K or Mg.
It's banned in the US too.
(Score: 0) by Anonymous Coward on Monday February 12 2018, @05:37PM (1 child)
In fairness, this is an FDA ban on domestic sales of kratom, not a ban on its possession or import. A pharmaceutical company that wishes to isolate and market active chemicals here would in no way be precluded from doing so, especially since this ban doesn't in any way weigh in on the sale of the active chemical, merely the plant.
Notions of analogs and containers and all that are not applicable here, as this isn't a DEA schedule.
(Score: 2) by takyon on Monday February 12 2018, @05:43PM
The DEA is not far behind. They pulled back after an outcry, but they will probably try to use the FDA's "evidence" to support scheduling it.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2) by requerdanos on Monday February 12 2018, @08:44PM
We aren't taking digoxin here; we're taking mitragynine and 7-hydroxymitragynine, and I have not seen any evidence that their respective alkaloid concentrations in the plant matter deviates in any unexpected way.
If you were unlucky and a batch of kratom had an unexpectedly high quantity of mitragynine or 7-hydroxymitragynine, you might give a person feelings of euphoria and/or discomfort for several hours.
Studies at places like Columbia University [acs.org] and University of Massachusetts Medical School [scientificamerican.com] indicate that unlike opioids (or "unlike other opioids" if you class these as such), mitragynine and 7-hydroxymitragynine don't have the respiratory depression effect that causes these overdose deaths that are behind the current "opioid crisis."
Of course, these compounds have an LD-50 *somewhere*, but the point is that their wide theraputic index [wikipedia.org] is nothing like the narrow tightrope walk that you're describing.
It makes sense that people who are unsettled by the thought of dosages that are not 100% consistent would prefer something like a standardized extract to just eating kratom leaves, but that scarcely seems to be the objection here.
(Score: 2) by edIII on Monday February 12 2018, @07:44PM (4 children)
Hmm, yeah, but I was smoking weed before it was recreational. Civil disobedience will start to be really effective when you have jury nullification. I believe that is what happened with the J20 prosecutions. The jury could see that it was about regulating unpopular speech and suppressing legal protests. They've let most of them go, and are continuing to double down on what is left. I predict that will also be jury nullification. Trump isn't popular, he didn't win the popular vote, and most people are on the side of the protesters.
Kratom, Big Pharma, and Law Enforcement are going to play out the same game. I wouldn't convict somebody of possessing Kratom, much less distributing it. I'm not particular interested in trying it either, but I'm also not particular interested in nasty veggies like asparagus. To each their own.
Government will always be trying to get power back, and with the astounding abuses of power that the DEA along with local enforcement have performed, they don't want to let go. When you have some LEO who is corrupt and willing to steal from the "bad guys", that's how you get them with sports cars, and all the trappings of wealth that the drug lord had.
The people that are trying to regulate Kratom are nothing more than state sponsored highwaymen.
Technically, lunchtime is at any moment. It's just a wave function.
(Score: 2) by requerdanos on Monday February 12 2018, @08:46PM (2 children)
Jury nullification is a good and necessary thing. The question I have for you is this: How do you avoid getting excluded from the jury pool during jury selection?
(Score: 0) by Anonymous Coward on Tuesday February 13 2018, @03:45AM
Except that unless you convince the _entire_ jury to nullify, you risk a mistrial and a more hostile jury for the poor SOB whose life you’re toying with to take your personal agenda to court, which is why it is a weapon of last resort not to be deployed by fools, which is to say, almost everyone.
(Score: 2) by edIII on Tuesday February 13 2018, @07:23PM
Just act like an ordinary person that doesn't have their mind made up. It would depend on the lawyer asking the questions. I guess my answer is "carefully"
Technically, lunchtime is at any moment. It's just a wave function.
(Score: 2) by requerdanos on Tuesday February 13 2018, @08:23PM
Same or poorer value system and care for others, as well.
(Score: 0) by Anonymous Coward on Monday February 12 2018, @06:14AM (1 child)
Kratom's chemical properties are not under the jurisdiction of the FDA. Someone should let them know.
This is insanity.
(Score: 3, Informative) by requerdanos on Monday February 12 2018, @07:09PM
It's looking bad for kratom, but I don't think it's as bad as the headline makes it sound; it may be misleading.
Here's why (FTFS):
This is from a strongly worded press release--a press release that doesn't say that "The FDA" is "Labeling" kratom as an opiod, just that in their opinion, that's what it is (despite evidence that it binds in a different way to the receptors, that it does not depress respiration as do opiods, etc.). And press releases are not the mechanism by which the FDA classifies drugs.
The regulatory labeling might not be far behind, but it hasn't happened yet.
(Score: 5, Informative) by hemocyanin on Monday February 12 2018, @08:07AM (5 children)
https://en.wikipedia.org/wiki/Mitragyna_speciosa#Death [wikipedia.org]
15 deaths in a three year span is 5/year (assuming it was the kratom and not anything else found along with it). Sounds like the ensuing war on Kratom will be extremely useful. Particularly when compared to the dangers of sleeping in your own bed:
(Score: 2) by c0lo on Monday February 12 2018, @10:13AM (1 child)
Quickly, ban sleeping in bed and using blankets or sheets.
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 0) by Anonymous Coward on Monday February 12 2018, @07:10PM
>> Quickly, ban sleeping in bed and using blankets or sheets.
It looks like Darwin has taken care of the problem already and will continue to do so?
(Score: 2) by bzipitidoo on Monday February 12 2018, @10:37AM (1 child)
Wow, I thought drowning in your own bathtub, with only an inch of water present, was the most pathetic way to die. But strangling with your own bedsheets is arguably worse.
Falls now, those are more respectable. Stairs are much more dangerous than people realize. I've slipped on stairs carpeted with medium length fiber because the nap was oriented upward and flipped downward as I stepped on it.
(Score: 2) by hemocyanin on Tuesday February 13 2018, @04:49AM
I came across one link I didn't use because it didn't seem a respectable source, but apparently, 450 people die in the US from falling out of bed every year. https://www.oddee.com/item_98002.aspx [oddee.com]
(Score: 2) by realDonaldTrump on Tuesday February 13 2018, @07:55AM
It's an accident that they die. It's not an accident that they get strangled. It's a sex thing. Let me mention a couple of guys, very famous. Michael Hutchence from INXS. David Carradine from Kill Bill. They died having VERY SPECIAL sex. Be careful, folks. Have a medical guy -- or lady -- around when you do those special things. Not a Fake one. The medical person, if you want, can be special too. Remember -- very important -- a Fake medical person can only do Fake medical. Or just do sex the regular way. I've had so much fun and made so many beautiful children that way!
(Score: 2) by opinionated_science on Monday February 12 2018, @12:17PM (5 children)
Did they publish a list somewhere?
As someone who *actually* has designed molecules, it would be nice to see their methodology.
Especially, since this would suggest some new thinking...
(Score: 0) by Anonymous Coward on Monday February 12 2018, @12:51PM (1 child)
From TFS:
Apparently how the FDA came to the conclusion that kratom was an opioid is based on a black box computer model of some kind.
(Score: 2) by Freeman on Monday February 12 2018, @05:40PM
So, a software bug / feature? The only reason to have a "black box" is to protect something. In aviation, it's flight recorder data, which you want to be able to survive practically anything. When applied to software, it's called, making sure I can milk them for all they're worth. I.E. Money.
Joshua 1:9 "Be strong and of a good courage; be not afraid, neither be thou dismayed: for the Lord thy God is with thee"
(Score: 2) by requerdanos on Monday February 12 2018, @07:18PM (2 children)
I remember reading in a different article that the concerns were mitragynine and 7-hydroxymitragynine, and that of special concern were "enhanced" kratom formulations with a higher proportion of the latter (some of which someone-who-isn't-me may or may not have a good supply of, and might use to help stay active in the face of chronic pain).
The FDA statement [fda.gov] here is light on details, but does mention mitragynine:
(Score: 2) by opinionated_science on Tuesday February 13 2018, @02:11AM (1 child)
In other words, they have a strong disincentive in letting you *see* how they set some new rule.....
(Score: 2) by realDonaldTrump on Tuesday February 13 2018, @08:02AM
Folks, I'll be following #ReleaseTheModel [twitter.com].