kratom

A Twitter Tiff Between Former Federal Health Officials Highlights the Weakness of the Case for Banning Kratom

Former Assistant Secretary for Health Brett Giroir says former FDA Commissioner Scott Gottlieb's support for a ban was based on "embarrassingly poor evidence."

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Scott Gottlieb, former head of the Food and Drug Administration (FDA), says he is "convinced" that kratom, a pain-relieving leaf from Southeast Asia, is "fueling the opioid addiction crisis." To the contrary, kratom enthusiasts argue, the plant is "the cure for the opioid epidemic."

There is not much evidence to support either position. But as a recent Twitter tiff between Gottlieb and former Assistant Secretary for Health Brett Giroir shows, the argument about whether the federal government should ban kratom hinges on the question of where the burden of proof belongs.

Gottlieb seems to think any potentially dangerous psychoactive substance should be banned unless it meets the FDA's strict criteria for approval as a medicine. If a drug is not explicitly permitted, in other words, it should be prohibited by default. Giroir, by contrast, thinks the federal government has an obligation to present compelling evidence that kratom poses an intolerable threat to public health and safety.

Kratom—which acts as a stimulant or a sedative, depending on the dose—has been used for centuries in countries such as Thailand, Malaysia, and Indonesia to ease pain, boost work performance, and wean people from opiate addiction. In recent years, kratom has gained a following in the United States, sold by online merchants and head shops as an herbal medicine, a dietary supplement, or a legal high.

In August 2016, the Drug Enforcement Administration (DEA), invoking its emergency powers under the Controlled Substances Act, announced that it planned to put kratom's active ingredients in Schedule I. That category supposedly is reserved for drugs with "a high potential for abuse," "no currently accepted medical use," and "a lack of accepted safety" even under medical supervision. The fact that Schedule I drugs still include marijuana, which is legal for medical or recreational use in 36 states, suggests how loosely and arbitrarily those criteria are applied.

The DEA's announcement, which claimed kratom posed "an imminent hazard to public safety," provoked an uproar among consumers, businesses, and members of Congress, prompting the agency to backtrack two months later. Instead of imposing an emergency ban on kratom, the DEA said, it would seek advice from the Department of Health and Human Services (HHS), which includes the FDA, about how to proceed.

Gottlieb thought the answer was obvious. In October 2017, HHS recommended that kratom join marijuana in Schedule I. But Giroir rescinded that recommendation in August 2018, saying there was not enough evidence to justify it.

"We were prevented by HHS from moving forward with the scheduling of Kratom," Gottlieb complained on Twitter last Friday, "and I'm convinced it's fueling the opioid addiction crisis." He urged the Biden administration to proceed with a kratom ban.

"FDA's recommendation was rejected [because] of embarrassingly poor evidence & data, and a failure to consider overall public health," Giroir replied. "If #Kratom is fueling opioid addiction, prove it; and then [HHS] should reconsider."

Giroir's strong language is fully justified in light of Gottlieb's weak case for banning kratom, which leaned heavily on unverified anecdotes. The FDA claimed kratom, which according to federal survey data is consumed by about 2 million Americans every year, had been implicated in 44 deaths worldwide over nine years. But those cases typically involved multiple drugs and/or underlying medical conditions.

In a 2018 paper commissioned by the American Kratom Association, Jane Babin, an attorney and molecular biologist, noted that "the FDA did not independently verify or perform any due diligence on the death reports" and that the "FDA's own documents indicate that every reported case involved other factors." This example, which Kayla Stetzel described in a 2018 Reason piece, gives you a sense of how rigorous the FDA's approach was:

A 22-year-old man consumed a kratom mixture he ordered online along with an "unknown tablet." This consumption "was followed by an incident, during which the patient fell from a window of the first floor before going to bed" without receiving medical treatment. He was found dead the next morning, and the medical examiner determined that he choked on his vomit while he slept. The man had a history of mental illness, and a prescription drug history that included pipamperone (an antipsychotic used for treating schizophrenia), fluoxetine (an SSRI used to treat anxiety, OCD and depression), queiapine (another antipsychotic), olanzapine (another antipsychotic), etizolam (a benzodiazepine analog), pregabalin (a nerve pain medication often used to treat seizures), lorazepam (a benzodiazepine) and triazolam (a benzodiazepine used to treat severe insomnia that can also cause psychotic episodes). Oh, and he also used kratom. The FDA report does not discuss the extent to which these drugs may have contributed to the man's mental state, instead summarizing his demise with this line: "The patient was found dead in his bed on the morning following the consumption of an herbal mixture."

Babin concluded that "the FDA has relied on a strategy of manipulating, obscuring, and ignoring science in its inexplicable zeal to impede public access to the natural botanical kratom." While you might dismiss that gloss as self-interested pleading by the kratom industry, it is consistent with earlier research on kratom's hazards.

"Kratom is considered minimally toxic," noted a 2015 literature review in the International Journal of Legal Medicine. "Although death has been attributed to kratom use, there is no solid evidence that kratom was the sole contributor to an individual's death." As Giroir noted in 2018, the FDA never performed "a scientifically valid assessment of causality in the current few deaths in which kratom was co-utilized with known lethal drugs such as fentanyl."

Even if the FDA's tally of deaths is accepted at face value, it suggests that kratom is far less hazardous than many commonly used intoxicants and medications. The FDA cited an average of fewer than five possibly kratom-related fatalities per year worldwide.

According to the Centers for Disease Control and Prevention (CDC), alcohol causes about 88,000 deaths a year in the United States alone. The CDC counted nearly 50,000 opioid-related deaths (primarily involving fentanyl and heroin) in 2019, and it expects the 2020 total will be substantially higher. Commonly prescribed benzodiazepines such as Xanax, Valium, and Ativan were involved in nearly 10,000 drug-related deaths in 2019. Even FDA-approved, over-the-counter analgesics such as aspirin, ibuprofen, and acetaminophen are implicated in thousands of deaths a year.

Kratom looks pretty benign by comparison. Perhaps recognizing that fact, Gottlieb is now emphasizing an alleged link between kratom use and opioid addiction. But as Giroir pointed out in 2018, the FDA never made "a scientific determination based on data" of whether kratom "actually serves as a gateway drug that promotes further use of more dangerous opioids." It had not even done "a scientific assessment of the actual scale of dependence and/or addiction" to kratom itself.

Giroir cited an animal study that found mitragynine, kratom's main psychoactive ingredient, "does not have abuse potential and actually reduced morphine intake," which is consistent with the notion that kratom is a harm-reducing alternative to more dangerous drugs. He suggested such findings, if confirmed, indicate that kratom does not meet the "high potential for abuse" criterion for inclusion in Schedule I.

Giroir warned that banning kratom could cause "adverse consequences" such as "intractable pain, psychological distress, [and] risk of suicide"; "transition to proven deadly opioids"; or "transition to other potent or harmful drugs." That is what he means when he refers to the FDA's "failure to consider overall public health." Giroir also worried that placing kratom in Schedule I could stifle "critical research" on kratom's "complex and potentially useful chemistry."

Gottlieb's position, by contrast, is that kratom should be banned until someone invests millions of dollars and years of research to persuade the FDA that it is safe and effective as a treatment for a specified condition. "It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms," he said in 2017. "I understand that there's a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people's health. We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA's Center for Drug Evaluation and Research that's dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom."

In the meantime, even if kratom remains unscheduled, the FDA will continue to treat dietary supplements that contain it as "adulterated." The Twitter spat between Gottlieb and Giroir was prompted by the FDA's announcement that it had seized "207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom." Citing "substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse," Judy McMeekin, the FDA's associate commissioner for regulatory affairs, promised that the agency "will continue to exercise our full authority under the law to take action against these adulterated dietary supplements." She noted that "there are currently no FDA-approved uses for kratom."

The FDA cannot abide the idea that Americans might use psychoactive substances, regardless of how dangerous they actually are, that have been neither approved as medicines nor, like alcohol and tobacco, explicitly exempted from scheduling. But that is exactly the opposite of the presumption that should prevail in a free society.

NEXT: Federal Cops Attacked a 70-Year-Old Vietnam Veteran and Then Avoided Accountability in Court

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  1. So Gottlieb is a blowhard, and Girior called him on it. Sounds about right.

    Gottlieb routinely makes asinine comments on CNBC.

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  2. Safrole has been banned since 1962 and is why you can’t buy real root beer and what you can buy tastes like toothpaste. Sweet spirit of nitre which was a common otc med and was banned in 1980 and no one will pay millions to test it for the government’s appoval. Zubrowka, the Polish vodka, is banned because it contains coumarin. All these ingredients are harmless unless you take it in such massive doses that can kill a rat.

    1. You couldn’t get aspirin approved today.

      1. Today, even Tylenol would never be removed from prescription-only.

  3. banned since 1962 and is why you can’t buy real root beer and what you can buy tastes like toothpaste. Sweet spirit of nitre which was a common otc med and was banned in 1980 and no one will pay millions to test it for the government’s appoval. Zubrowka, the Polish vodka, is banned because it contains coumarin. All these ingredients are harmless unless you take it in such massive doses that can kill a rat. , https://wapexclusive.com/new-song-d-black-apply-the-pressure/

    1. are these bots copying comments and adding a link?

      1. That’s been happening for a while.

        1. dicks.

          1. Thought to copy your comment and add a link as a joke — but I don’t want to google that.

  4. I don’t have time to dig into the numerous examples where Reason shamelessly humped Gottlieb’s tweets because they supported Reason’s COVID narrative. Here’s but one example. Gottlieb has an extensive history of cherry-picking. But conveniently, all that was ignored last year.

    1. Better yet, why don’t we just stick to the current subject? Kratom is safe and effective and Gottlieb is knowingly falsifying or manipulating information on kratom specifically to benefit his buddies in the Rx drug industry.

      Regarding the Reason “humping” of Gottlieb in that article, they were pretty passively stating that efforts to curb the spread of COVID were yielding unpredictable results (hence not deserving of lockdowns).

      Chill out, man.

  5. Gottlieb thought the answer was obvious. In October 2017, HHS recommended that kratom join marijuana in Schedule I. But Giroir rescinded that recommendation in August 2018, saying there was not enough evidence to justify it.

    Wrong outside of normal parameters.

  6. Most of the people in the kratom world have a more nuanced opinion than that kratom is the “cure” for the opioid crisis or anything else. The bottom line is we should have the right to access substances for the pursuit of our own happiness. Kratom advocates are calling for regulation of products so they know that what they’re getting is uncontaminated pure leaf kratom. But the FDA acting as representatives of an industry that wants a person with epilepsy to spend $35K a year on “Epidiolex” instead of buying CBD or growing hemp in their garden will not stand for anyone accessing kratom until it can be monopolized by oh say, Pfizer, where Gottlieb landed after passing through the revolving door from the FDA.

  7. What was it that looked good about Gottlieb initially that got him favor for a while from libertarians and Trump? I forgot, but I think it was because he temporarily replaced someone who was worse — someone who wanted to stifle progress even more badly than the statutes seemed to call for.

    1. Gottlieb was an Obama appointment, so I’m not sure what you mean.

    2. Gottlieb took a don’t-ban-it position in the vaping controversy.

  8. Even if it were 100% true that Kratom had killed 44 people worldwide over the past nine years, that still isn’t compelling justification for a ban. Peanuts probably killed more people than that yesterday.

    1. Yeah, the 44 number really shows that it’s an extremely safe drug more than anything.

      1. 44 out of how many people and PRECISELY how much did they use? That’s the missing information.

        Less than 44 people died while chewing 5 pounds of tobacco during a spacewalk on Sundays between 2005 and 2014. Does that mean it’s safe?

  9. The debate about whether the federal government should ban Krettom depends on where the burden of proof lies
    https://www.orologilusso.eu/

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  12. I am sure there is plenty of work for the FDA and they don’t need to take on Kratom. I find the supplement world a bit goofy. That said let people do what they want unless there is a real and documented problem. Two time Noble prize winner Linus Pauling was a huge vitamin C advocate. Do I think it helped, other than the OJ industry, no, but who cares.

    I also think it is crazy to look at what people do with these supplement when there are plenty of drugs that are used for off label treatments without testing. Let get some of these off label uses checked out before going after Kratom.

    1. Yeah. Screw Orrin Hatch.

      May he rot in hell for creating the framework in which snake oil can be sold, as long as it is marketed as a supplement rather than a medicine.

      https://khn.org/news/how-sen-orrin-hatch-changed-americas-health-care/amp/

  13. Great article sullum, you do a super job with guns, drugs and goverment overreach etc.. Stay away from anything that will trigger your chronic TDS.

  14. Thank you, Reason!

    This needs more coverage and Gottlieb et.al are using distorted statistics, lying by omission (claiming kratom caused deaths in people whose systems contained more of far more dangerous drugs), and doing everything in their power to CONTINUE the opioid crisis or at least shift the effort in curbing it to profit seeking ventures in the biotech and big pharma industries.

    Last thing we need is ANOTHER commonly used substance making its way to the DEA’s schedule, but then again – the DEA is a make-work jobs program, and with MJ being gradually legalized, they need to find ways to keep themselves employed.

  15. Isn’t the whole War on Drugs based on unverified anecdotes? Or did someone do a study proving the causal effects of LSD flashbacks on jumping out of high-rise windows?

    1. A woman with many failed suicide attempts once took LSD and then picked a method that couldn’t fail. And her family publicized her jump out a window as caused by LSD, without mentioning all the previous suicide attempts.

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