FDA: Scott Gottlieb, M.D., Rightly Warns Public About Kratom

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With a government creating misguided policies using false media narratives about pain doctors and patients(1), the opportunity is open for groups selling "natural" analgesic alternatives, but the public should beware. If it is an alternative to medicine, usually it either does not work at all or, if it does, its effects are unknown.

Kratom does work, but what it does may be bad, and so the U.S. Food and Drug Administration has rightly issued a new warning about it. When I first heard about Kratom, in 2015, I was excited. Finally, I could talk about a supplement that was not a placebo, and I could once again criticize government overreach and fearmongering. But when I showed the structure to our chemist-in-residence Dr. Josh Bloom he shook his head and uttered the words that would eventually send panic throughout the herbal community: "This thing will kill Godzilla." But let's wait on an article, I told him then, because if it's that dangerous the federal government is going to kick some doors in, and then it will be topical. By January of 2016 they had done just that.

We were concerned because it is marketed as a natural supplement yet is very much a drug. Worse, it is really a mixture of dozens of drugs and therefore might rightly have been considered a Schedule I substance—no legal use in the US and a high potential for abuse. Trade groups had no real answer for that because they were simultaneously arguing it "works" as an analgesic yet then claiming it should not have to go through the same regulatory approval every other drug must go through, simply because it's derived from the leaves of the Mitragyna Speciosa tree. They got the first part right. It does stuff.

Kratom. It does work. And that is why it needs to be regulated.

Yet its being "natural" and therefore exempt from oversight is what they get wrong. Worse, there were numerous bogus medical claims being made, which is also a legal no-no. Kratom hucksters are leveraging "opioid" publicity issue and their plant-based alternative to gain wealth but that is both fraudulent and unethical. Kratom is an opioid, just like codeine or hydrocodone, plus it has components of a psychoactive drug. It has been directly linked to psychosis, seizures, and deaths. Its known side effects include rapid heart rate, irritability, drowsiness, nausea and hypertension.

Until it is shown to be safe, it should not be used for recreation or pain. If it is a viable drug, treat it like a drug and put it through the regulatory process.

Kratom trade groups and users are going to claim that their supplement being criticized is another example of a vast corporate conspiracy to promote sound science and health, but this is instead a safety issue. It being a "natural" analgesic because the drug is from the leaves of a tree remains irrelevant. If they care about their customers, they will use this opportunity to become part of the solution, and not circle the wagons around the problem every scientist can see they have.


(1) We made "fentanyl" part of the national lexicon when we testified at FDA that the problem was not legal prescriptions and that pharmaceutical companies were not marketing addiction - doctors over-prescribing were bad actors, not the norm - it was illegal forms that were creating recreational addicts and killing users. Regardless, the government conflates legitimate pain patients with recreational addicts in their talk about the opioid crisis.