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FDA declares popular alt-medicine kratom to be a deadly opioid

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avcpl

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https://www.nbcnews.com/storyline/a...-alt-medicine-kratom-be-deadly-opioid-n845311

The Food and Drug Administration declared kratom a plant-based stimulant with growing popularity to be an opioid on Tuesday, opening a new front in its battle to get people to stop using the herbal supplement.

New research shows kratom acts in the brain just as other opioids do, FDA Commissioner Dr. Scott Gottlieb said in a statement. And he said the agency has documented 44 cases in which kratom at least helped kill people often otherwise healthy young people.

Taken in total, the scientific evidence we?ve evaluated about kratom provides a clear picture of the biologic effect of this substance, Gottlieb wrote.

Kratom is used by some as a home remedy for opioid addiction and by others just for fun.

Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use.

Last November, the FDA cautioned people not to use kratom.

Supporters of kratom use have been fighting to keep it legal for years. The Drug Enforcement Administration temporarily listed kratom as a Schedule 1 controlled substance last August, but withdrew the decision after an outcry and a targeted petition effort.

The FDA says scientific evaluation shows there is no wiggle room.

As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn't just a plant it's an opioid, Gottlieb wrote.

Sellers market it as a safe, "plant-based" product. But Gottlieb pointed out that heroin comes from plants, also.

There are drugs on the market that have been demonstrated to be safe and effective for helping people treat opioid addiction, he said.

For individuals seeking treatment for opioid addiction who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider, Gottlieb said.

Combined with psychosocial support, these treatments are effective. Importantly, there are three drugs (buprenorphine, methadone, and naltrexone) approved by the FDA for the treatment of opioid addiction, and the agency is committed to promoting more widespread innovation and access to these treatments to help those suffering from an opioid use disorder transition to lives of sobriety,? he added.

The American Kratom Association said the FDA is biased against the product.

"This is an unprecedented abuse of science to create a new computer program that is clearly garbage in garbage out avoiding the rules of the Controlled Substances Act and making unproven claims that have been proven to be untrue," the AKA said in a statement.

Gottlieb noted that some people also use kratom to try to treat pain.

There are also safer, non-opioid options to treat pain," he wrote.

"We recognize that some patients have tried available therapies, and still have unmet medical needs. We?re deeply committed to these patients, and to advancing new, safe and effective options for those suffering from these conditions.?

The FDA released detailed accounts of several of the deaths. The victims often had mixed kratom with other substances, including chemicals taken out of inhalers and found in over-the-counter cold and flu drugs.

Kratom is widely available online. Federal agents have seized some kratom from retailers, but it was not immediately clear what the federal government plans to do about the many online outlets.
 
very shit move.

44 deaths in history where kratom "may have contributed"

Aren't there about 44 deaths an hour from alcohol and even more from cigs? maybe the FDA should promote the illigality of those first before they work on making kratom illegal
 
Too much money lobbied in Washington by big tobacco/alcohol for that to ever be possible man.
 
That's not really bribes... he worked for them, and they payed him, that's all it says.
 
LucidSDreamr said:
very shit move.

44 deaths in history where kratom "may have contributed"

Aren't there about 44 deaths an hour from alcohol and even more from cigs? maybe the FDA should promote the illigality of those first before they work on making kratom illegal
Click to expand...

I wonder how many people are dying each month from fent analogues in the USA alone?
A lot more than 44.

This is bad.
I mean, kratom has been illegal in australia since long before it became popular (was banned here because it was [once?] banned in thailand (geography and all that - and a reactionary govt that bans everything) - but we don't have the same terrible opioid crisis happening here (yet...fingers crossed it doesn't happen the same way here).

Having access to a mild, relatively benign opioid seems like it must save lives, surely?
 
Christ, the title is a jump isn't it?
They never said 'deadly opioid', just that it contains 'opioids.

And LucidSDreamr, there's no mention of bribes to ban Kratom in your link.
 
Show me one single instance, single death, in which Kratom was the ONLY drug found post-mortem. Every case I've looked into has had fatal levels of other drugs in the victim's system.
 
This move is appalling. Guess its time to stock up while i still can.
 
This is where a non-profit like MAPS needs to step in and run some trials. The FDA will never condone the use of a pharmacologically-active plant for medical purposes if it hasn't been put through clinical trials, full stop. Pharmaceutical companies have no incentive to run these trials due to a lack of patentability.
 
Gaz_hmmmm said:
Christ, the title is a jump isn't it?
They never said 'deadly opioid', just that it contains 'opioids.

And LucidSDreamr, there's no mention of bribes to ban Kratom in your link.
Click to expand...

Guess that half a million the FDA director got from pharma was just them being nice. A bribe is exactly what it is.
 
LucidSDreamr said:
Guess that half a million the FDA director got from pharma was just them being nice. A bribe is exactly what it is.
Click to expand...

That was money he was paid as consultant before he became the FDA commissioner. He would not be able to take a job like that now.
 
S.J.P. said:
This is where a non-profit like MAPS needs to step in and run some trials. The FDA will never condone the use of a pharmacologically-active plant for medical purposes if it hasn't been put through clinical trials, full stop. Pharmaceutical companies have no incentive to run these trials due to a lack of patentability.
Click to expand...

Saying there is no medicinal use for something like kratom is almost funny considering the federal cannabis situation. Frankly I was surprised kratom didn’t get scheduled when the DEA first too a serious look. Seems like patient and doctor advocate groups stepped up to pressure the government not to take action... until now :\

Hopefully people stand up for their rights again with this.
 
Sellers market it as a safe, "plant-based" product. But Gottlieb pointed out that heroin comes from plants, also.
Click to expand...

Lol

Combined with psychosocial support, these treatments are effective. Importantly, there are three drugs (buprenorphine, methadone, and naltrexone) approved by the FDA for the treatment of opioid addiction, and the agency is committed to promoting more widespread innovation and access to these treatments to help those suffering from an opioid use disorder transition to lives of sobriety,? he added.
Click to expand...

Yeah, ditch that nasty kratom for a healthy, non addictive substance like methadone :)
 
In some ways methadone probably is safer than kratom, but a nasty methadone habit is certainly more difficult than kratom to deal with (again, at least in some sense).

Honestly coming off like six months of kratom use, the psychological symptoms were a lot more challenging than they were getting off a much more serious methadone habit. But by the same token, kratom’s physical symptoms where easier to deal with than methadone.

The insanity is that banning kratom will just send people back to the black market, trying to scam doctors, or switching to a harsher drug unlike alcohol. Fucking stupid is what it is, at least from a public health standpoint. But then again our entire drug policy in the US doesn’t really give a fuck about public health.
 
Kratom and the FDA
Derek Lowe
Science Translational Medicine
February 8th, 2018

The FDA has made an announcement about kratom, a plant preparation (Mitragyna speciosa) that (depending on who you ask) is a drug of abuse or a way for people to get off of other drugs of abuse. Specifically, it's used as a way to mitigate opioid withdrawal symptoms, which is reason enough to wonder if it contains opioid ligands itself.

And that's what the agency says is the case. The key part of their case, though, is not so much pharmacological as computational:

"Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds' opioid properties. These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body."

Specifically, the FDA says that they've modeled the most common compounds found in kratom and determined that they have similar 3D pharmacophores to known opioid ligands, and they've done docking studies with the mu-opioid receptor, among others, that would predict potent bind constants. Now, that's not the language the press release uses, of course - I’ve translated from the talk of "3-D computer technology" and the like. Trying to impress an experienced drug discovery researcher with talk of advanced 3-D modeling technology is futile, by the way - we've seen it work, we've seen it fail, we've seen several generations of the software, and we've seen people who know how to use it and people who flail it around like a spiked club.

So as an industrial medicinal chemist, I have some problems with the way the FDA is making its case here. It's true that computational models of drug function have become more common, but "reliable" is a tricky word. If these things were truly reliable, to the point that you'd be comfortable setting government policy according to their results, then we folks in the drug industry wouldn't have to physically screen so many new compounds in actual assays. But we do. Computational models can be useful, but that utility has to be checked against experiment every time to make sure that you're on the right track, since the number of wrong tracks is basically infinite.
Click to expand...

Read the full story here.
 
toothpastedog said:
In some ways methadone probably is safer than kratom, but a nasty methadone habit is certainly more difficult than kratom to deal with (again, at least in some sense).

Honestly coming off like six months of kratom use, the psychological symptoms were a lot more challenging than they were getting off a much more serious methadone habit. But by the same token, kratom’s physical symptoms where easier to deal with than methadone.

The insanity is that banning kratom will just send people back to the black market, trying to scam doctors, or switching to a harsher drug unlike alcohol. Fucking stupid is what it is, at least from a public health standpoint. But then again our entire drug policy in the US doesn’t really give a fuck about public health.
Click to expand...

Kratom is just about the most benign substance out there, unless it kills your kidneys or something. Honestly I've never even experienced any kind of WD symptom worthy of the name from kratom, not even after prolonged stretches of use followed by sudden abstinence. It's like cannabis to me in that respect. That's my experience with it anyway.
 
You’re rather fortunate then. It’s not too hard to become dependent on kratom, and even though physically the withdrawal isn’t too horrible, kicking a big habit cold turkey is pretty uncomfortable. Kratom, particularly with heavy use, is probably more problematic in terms of health stuff than other opioids are - especially for people with preexisting health issues.

Kratom is definitely far less benign than something like cannabis, but with responsible use it isn’t particularly harmful for most people for sure. Problems seem to happen with high dose daily use, which isn’t that hard to become accustomed to. Used once a week it’s probably pretty safe.

And these articles are a perfect example of how a narrow focus on neurobiology is a failure in terms of public health and drug policy. The second one is much better than the first IMHO
 
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Kratom helped me curb my pill habit. I used it as a maintenance drug for a while and after 6 or so months it got old so i decided to cold turkey. I am now only taking hydrocodone 1-2 days a month and that?s it.

I have cravings but they aren?t nearly as bad as if i CT?d off tramadol or hydrocodone. I really hope they don?t fuck with the legality of kratom.
 
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