OHSU Researchers Find ‘No Evidence’ to Support Use of Kratom

By Pat Anson, PNN Editor

A federally funded review of plant-based treatments for chronic pain has yet to find adequate clinical evidence on the benefits or harms of kratom, an herbal supplement used by millions of Americans to relieve pain, anxiety, depression and other medical conditions.

In an update released this week, researchers at Oregon Health & Science University (OHSU) reported that some cannabis products provide small to moderate pain relief, a finding based on a systematic review of two dozen clinical trials of cannabis.  But no similar studies were found to support the use of kratom or any other plant.   

“No evidence on other plant-based compounds, such as kratom, met criteria for this review,” researchers said.

OHSU was awarded a contract last year by the Agency for Healthcare Research and Quality (AHRQ) to review the evidence for cannabis, kratom and other plant based treatments for chronic pain.  

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia. Although it has been used for centuries as a natural stimulant and pain reliever, few clinical trials have been conducted to test kratom’s efficacy or safety. The few studies that have been conducted were excluded by OHSU researchers due to their size, methodology or because they weren’t published in English.

For example, a 2020 Malaysian study that found kratom provided “a substantial and statistically significant increase in pain tolerance” was excluded because the young men who participated in the one-day trial were considered an “ineligible population.” OHSU researchers excluded all studies lasting less than 4 weeks.

“The conclusion that there is no evidence to support the effects of kratom on chronic pain is absurd.”

— Mac Haddow, American Kratom Association

“Setting aside the disappointment that AHRQ does not appear to be taking the purpose of the review of plant-based compounds very seriously, the conclusion that there is no evidence to support the effects of kratom on chronic pain is absurd,” said Mac Haddow, a lobbyist for the American Kratom Association.  “It’s like denying that Chicago is a windy city because the instrument that was selected for assessing wind speed was not used.”

Haddow said the AHRQ review should be expanded to include survey results from kratom users, animal studies and other types of research that don’t rise to the level of a clinical trial.

“The review appears to be excluding any research that is not a pharmaceutical development clinical trial model that would involve controlled kratom administration in a full-blown human clinical trial,” Haddow told PNN. “The deeply embedded bias against plant-based compounds that offer potential values for addressing the opioid crisis — or even providing a non-addictive and safer alternative for the management of acute and chronic pain should be a priority for the AHRQ.”

This isn’t the first time the quality of federal research into the safety and efficacy of kratom has been questioned. In 2018, the Department of Health & Human Services quietly withdrew an FDA request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. A former HHS official recently said the FDA’s recommendation was rejected because of “embarrassingly poor evidence & data.”

$2 Billion in Federal Grants

A final report on plant-based treatments for chronic pain is expected in August. As PNN has reported, OHSU researchers have recently conducted a series of reviews on a wide variety of pain therapies for the AHRQ, which are being used by the Centers for Disease Control and Prevention to revise and possible expand its controversial 2016 opioid guideline.   

Much of that research is being led by Dr. Roger Chou, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at OHSU.  Chou, who co-authored the CDC opioid guideline, is a prolific researcher who has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to reduce the use of opioid medication.

The contract on plant-based pain treatments is potentially worth up to $1.4 million for OHSU, a public research university that the federal government often turns to for medical research. According to the website GovTribe, in the last five years OHSU has been awarded nearly $2 billion in federal research grants to study everything from cancer and contraceptives to Alzheimer’s and Parkinson’s Disease.

OHSU paid $1.3 million back to the government to settle allegations that it misused grant money in its primate research center. Although the settlement was reached in 2018, it was not made public until recently in an Inspector General’s report, according the animal rights group Rise for Animals.

FDA Seizes 37 Tons of Kratom in Florida

By Pat Anson, PNN Editor

The Food and Drug Administration has announced a large seizure of kratom from a supplement packaging company in Florida, in what could be an escalation of the agency’s efforts to stop kratom sales in the United States.

Over 37 tons of kratom powder and over 200,000 units of dietary supplements containing kratom were seized earlier this month by U.S. Marshals at an Atofill warehouse in Fort Myers, FL. The company imports kratom from Indonesia and resells it in capsules and powder under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical and El Diablo. The seized products are worth about $1.3 million, according to the FDA.

In April, Atofil and dozens of other kratom exporters and importers were named by the FDA in an updated import alert which gives the agency broad powers to seize shipments of kratom. In a statement on Twitter, acting FDA Commissioner Janet Woodcock, MD, compared kratom to morphine.

“To protect the public health, the FDA will continue to take action against kratom-containing dietary supplements,” Woodocok said. “Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Kratom affects the same opioid brain receptors as morphine & appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence.”

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. A recent study estimated that about two million Americans use kratom to self-treat their chronic pain, anxiety, depression and addiction.

Kratom is sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions or market it as a dietary supplement. During an FDA inspection of Atofil earlier this year, investigators observed large quantities of kratom powder and capsules labeled as “herbal supplements.” In the eyes of the FDA, that is a violation of federal law that prohibits the sale of adulterated dietary supplements.

The U.S. Department of Justice, working on behalf of the FDA, filed a civil complaint against Atofil in federal court, alleging that kratom is a new dietary ingredient for which there is no adequate information on its potential risk to human health.

Mac Haddow, a lobbyist for the American Kratom Association, told PNN the court action and seizure amounted to “an end-around of the Controlled Substances Act” by the FDA and was “a pretty big expansion of their authority.”

‘Embarrassingly Poor Evidence’

A DEA effort to ban kratom in 2016 failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew its request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat.

Former FDA Commissioner Scott Gottlieb, MD, who regularly campaigned against kratom while heading the agency, says more action needs to be taken by the Biden administration.

“We were prevented by HHS from moving forward with the scheduling of Kratom, and I’m convinced it’s fueling the opioid addiction crisis. The Biden Administration should follow through on efforts of FDA, NIH, and DEA — and the new ASH should affirm health findings of these agencies,” Gottlieb said on Twitter, referring to Rachel Levine, MD, Asst. Secretary for Health at HHS.

Gottlieb’s tweet brought a rebuke from Brett Giroir, MD, a former four-star admiral in the U.S. Public Health Service and Asst. Secretary for Health in the Trump administration. It was Girior who wrote a 2018 letter to the DEA notifying the agency that HHS was withdrawing its request to schedule kratom.

“FDA doesn't schedule; it only recommends. FDA's recommendation was rejected b/c of embarrassingly poor evidence & data, and a failure to consider overall public health. If #Kratom is fueling opioid addiction, prove it; and then @HHS_ASH should reconsider,” Giroir tweeted.

Gottlieb responded with yet another tweet, claiming that “public health suffered” as a result of Girior’s action.

“It’s true: Brett Giroir unilaterally overruled a considered, multi year, scientific effort by the NIH, FDA, and DEA and a careful analysis in an act I found hasty and ill conceived,” said Gottlieb.

A 2020 study funded by the National Institute on Drug Abuse — which is part of the the NIH — concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

Study Estimates Two Million Americans Use Kratom

By Pat Anson, PNN Editor

A new study estimates that less than one percent of Americans -- about two million people --- use kratom, an herbal supplement that’s growing in popularity as a treatment for pain, depression, anxiety and addiction.

The study, one of the first to look at kratom use in the general population, is based on data from the 2019 National Survey on Drug Use and Health – the first year the annual survey asked respondents about kratom.

Researchers at New York University’s Grossman School of Medicine looked at data from over 56,000 people who participated in the survey and estimated that 0.7 percent of adults and adolescents in the U.S. used kratom in the past year.

Kratom use was more likely by people who also use cannabis, stimulants and cocaine, and was particularly common among those who misuse prescription opioids. About 10 percent of people diagnosed with opioid use disorder reported kratom use.

“It was not surprising at all that such a large portion of people with opioid use disorder use kratom. What I didn’t expect was to find kratom use to be independently linked to cannabis use disorder,” said study author Joseph Palamar, PhD, an associate professor of population health at NYU Grossman School of Medicine.

“A lot of people who use substances to get high also use other substances to get high — alone or in combination. If anything, I hope that results of this paper demonstrate not only that a lot of people with opioid use disorder use kratom, but also a lot of people who use other drugs have been adding this substance to their drug repertoires for whatever reason.”

Men, white people, and those with depression and serious mental illness were also more likely to report using kratom. Teenagers and adults over 50 were less likely to use it.

The findings are similar to those in a 2016 PNN survey of over 6,000 kratom users. A little over half said they primarily used kratom for pain relief, while others used it as a treatment for anxiety (14%), opioid withdrawal (9%), depression (9%) and alcoholism (3%).  Over 90% said kratom was “very effective” in treating their medical condition.   

“A lot of people who use kratom rave about its ability to decrease opioid withdrawal, but kratom itself can be addicting so people need to be aware and be careful. Kratom might indeed be able to serve as a useful tool for people seeking to get off opioids, but I think more research is needed to determine exactly how it should be used and how to use it safely,” Palamar said in an email to PNN.

The study, published in the American Journal of Preventive Medicine, notes that over 150 overdose deaths linked to kratom have been reported. But most of those overdoses also involved other drugs such as illicit fentanyl, heroin and cocaine, or prescription drugs such as benzodiazepines and psychiatric medications.    

“Given the high number of poisonings involving kratom combined with other drugs, I hope that at least people who decide to use it try to avoid combining it with other substances,” Palamar said.

Kratom comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions. The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

The American Kratom Association, an advocacy group for kratom consumers and vendors, claims that 10 to 16 million Americans use kratom. That estimate is based on exports to the U.S. reported by kratom growers in Indonesia.

FDA Updates Import Alert for Kratom

By Pat Anson, PNN Editor

Federal health officials may have dropped plans to schedule kratom as a controlled substance, but that’s not stopping the Food and Drug Administration from updating an import alert that gives the agency broad powers to seize shipments of the herbal supplement.

The alert targets dozens of kratom exporters and importers in the United States, Canada, Indonesia, Malaysia and the Philippines, and allows FDA inspectors to detain “without physical examination” dietary supplements and ingredients that contain kratom.  In an email, an FDA spokesperson told PNN the alert was updated for “minor changes” involved with one firm’s listing  

Kratom is an herbal supplement that comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction.

The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

“Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms,” the alert warns.

The FDA issued its first import alert for kratom in 2012, just as kratom was gaining in popularity in the U.S. Since then, several large shipments of raw kratom or kratom supplements have been seized. One of the largest seizures was in 2018, when 28 tons of kratom were confiscated at a South Carolina warehouse operated by Earth Kratom, a kratom wholesaler and vendor. The kratom was later incinerated.   

Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions or market it as a dietary supplement.

A lobbyist for the American Kratom Association, an association of kratom vendors and consumers, said the updated alert is part of the FDA’s “disinformation campaign” against kratom.

“The FDA routinely uses the import alerts in discussions with various stakeholders to highlight their claims that kratom is not ‘legally marketed’ in the United States, and by adding a recent date by way of an update makes it appear to be a recent action,” said Mac Haddow. “The import alert is an abuse of that authority that is supposed to apply to contaminated and adulterated products.

“In fact, the objections listed in the import alerts issued by the FDA technically only apply to importers who are subsequently making illegal therapeutic claims or as a dietary supplement on marketing materials. A bulk kratom importer is not subject to FDA's authority. Kratom processors who make no claims and sell kratom as a food are not subject to any pre-market approval by the FDA.”

Federal efforts to ban kratom in 2016 failed due to a public outcry. Two years later, federal health officials quietly withdrew their request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. The FDA, however, still maintains “significant potential safety concerns” about kratom. 

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

DEA: Drug Cartels Targeting Pain Patients as Potential Customers

By Pat Anson, PNN Editor

The Drug Enforcement Administration’s “National Drug Threat Assessment” is an interesting annual report that gives insight into drug trafficking and drug abuse trends in the United States that you don’t often see in the mainstream media..

The DEA’s 2020 report, released this month, is no exception. One hundred pages long, it covers a broad range of “unclassified” information about drug cartels, counterfeit medication and emerging trends in drug abuse.

“Although we have made progress in driving down the abuse of controlled prescription opioids, the United States continues to face challenges from both new and persistent threats,” said acting DEA Administrator Christopher Evans.

According to the DEA report, the diversion and abuse of opioid painkillers and other controlled prescription drugs (CPDs) are at their “lowest levels in nine years.”

While opioid pain relievers remain the most commonly abused type of prescription drug, most people don’t take them to get high.

The DEA said nearly two-thirds (64%) of drug users “identified relieving pain as the main purpose” for their misuse of painkillers – a staggering statistic that may say more about the poor state of pain care in the U.S. than anything else.

Ironically, the second most widely abused opioid medication was buprenorphine, which is combined with naloxone in addiction treatment drugs such as Suboxone and Zubsolv. The National Forensic Laboratory (NFLIS) reports that buprenorphine is abused far more often than methadone or hydrocodone, and appears poised to soon replace oxycodone as the most commonly abused prescription opioid. 

“Drug data reveals that buprenorphine reports from all participating federal, state, and local laboratories increased each year except a minor drop from 2018 to 2019. (NFLIS) reported a 50 to 67 percent decrease of hydrocodone, methadone, and oxycodone reports from 2014 to 2019, so the 27 percent increase of buprenorphine during that time frame was significant,” DEA said.     

Fentanyl Laced Counterfeit Pills

Not surprisingly, the DEA said illicit fentanyl was “primarily responsible for fueling the ongoing opioid crisis,” with Mexican drug cartels controlling most of the supply for the potent synthetic opioid. With hydrocodone, oxycodone and other legal opioid medications in short supply — and a lot of people with poorly treated pain — the DEA believes drug cartels are actively targeting pain sufferers as potential customers for counterfeit medication.

“The spread of fentanyl-laced counterfeit pills in the United States is likely due to Mexican TCOs (Transnational Criminal Organizations) seeking to further distribute fentanyl into prescription opioid user populations,” the DEA said. “The increasing number of counterfeit pills resembling prescription medications and users who may be pivoting to abusing illicit substances with waning CPD availability may prove to be a significant threat into 2021.”  

The counterfeit pill of choice for the drug cartels are fake 30mg oxycodone tablets, stamped with an “M” on one side and “30” on the other.

Known on the street as “Mexican Oxy” or “M30s,” the DEA says the blue tablets “demonstrate that traffickers are taking advantage of an established market for these pills.”

Illicit fentanyl tablets appear to be getting more lethal, with laboratory tests showing 26 percent of them containing a potentially fatal dose of fentanyl in 2019, compared to just 10 percent in 2017.

In one chilling paragraph, the DEA seemed to acknowledge it was losing the war on drugs to Mexican cartels and local criminal gangs.

“Barring significant, unanticipated changes to the illicit drug market, Mexican TCOs will continue to dominate the wholesale importation and distribution of cocaine, heroin, marijuana, methamphetamine, and fentanyl in U.S. markets. No other criminal organizations currently possess a logistical infrastructure to rival that of Mexican TCOs. Mexican TCOs will continue to grow in the United States through expansion of distribution networks and continued interaction with local criminal groups and gangs,” the agency warned.

Sometimes what is not disclosed in the DEA’s report is just as revealing as what is actually said. For example, while the DEA officially lists kratom as a “drug of concern” and even tried to ban the herbal supplement in 2016, the agency has never said a word about kratom in its annual threat assessment. Not in 2020. Not ever.  

Why is that? Is kratom not addictive or dangerous, despite all the public hand-wringing over the years by the Food and Drug Administration? In a 2018 letter to the DEA recently made public, federal health officials quietly withdrew their request to schedule kratom as a controlled substance because of “lack of evidence” it can be abused or posed a public health threat.

Feds Withdrew Request to Ban Kratom in 2018

By Pat Anson, PNN Editor

Federal health officials quietly withdrew their request for kratom to be classified as a Schedule I controlled substance in August 2018, according to a previously undisclosed letter to the U.S. Drug Enforcement Administration.

The letter from Brett Girior, MD, Assistant Secretary for Health & Human Services (HHS), to the DEA’s acting administrator cited concerns that “there is a significant risk of immediate adverse public health consequences to potentially millions of users if kratom or its components are included in Schedule I.”

Kratom is an herbal supplement comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction. Classifying kratom’s two active ingredients, the alkaloids mitragynine and 7-hydroxymitragynine, as Schedule I substances would effectively ban kratom by making its sale and possession illegal.  

The 2018 letter from HHS was made public this week by the American Kratom Association (AKA), an advocacy group for kratom consumers and vendors, which said it obtained the letter from Rep. Mark Pocan (D-WI).

“The decision by the FDA to not disclose the recission of their recommendation for scheduling of kratom that took place more than 2 ½ years ago has significantly misled policy makers, the media, and kratom consumers in the belief a scheduling decision was imminent,” Mac Haddow, Senior Fellow on Public Policy for the AKA, said in a statement. “Six states were duped by this messaging to pass bans on kratom sales, and a number of local county and city governments also based their bans on the FDA’s claims.

“Through all of this the FDA has remained silent and has failed to disclose that HHS reviewed their scheduling recommendation and took the unprecedented action to rescind the recommendation because the FDA had failed to meet its burden under the CSA (Controlled Substance Act).”

An FDA spokesperson said it was not up the agency to disclose the letter’s existence.

“While the FDA is an agency within HHS, the letter at issue was not the FDA’s to publicly disclose and any announcement regarding a decision to schedule or not schedule a potential controlled substance is made by the Drug Enforcement Administration, not the FDA,” the spokesperson said in an email to PNN.

‘Lack of Evidence’ Kratom is Harmful

Girior’s letter to DEA said there was a “relative lack of evidence” that kratom can be abused and posed a public health threat.

“Although there remains cause for concern for 7-hydroxymitragynine and potentially mitragynine, the level of scientific data and analysis presented by the FDA and available in the literature do not meet the criteria for inclusion of kratom or its chemical components in Schedule I of the CSA at this time,” Girior wrote. 

“There is still debate among reputable scientists over whether kratom by itself is associated with fatal overdoses. Further analysis and public input regarding kratom and its chemical components are needed before any scheduling should be undertaken.”  

The DEA tried unsuccessfully to list kratom as a Schedule I substance in 2016, calling it an “imminent hazard to public safety,” a decision that was reversed after a public outcry from kratom supporters. 

But federal efforts to demonize kratom continue to this day, led for a time by FDA Commissioner Scott Gottlieb, who claimed kratom was an opioid and should not be used to treat any medical condition. Gottlieb resigned as FDA Commissioner in 2019, eight months after Girior’s letter. The agency he led remains opposed to kratom.   

“Kratom products have been associated with significant potential safety concerns. While it is important to gather more evidence, data suggest that certain substances in kratom have opioid properties that expose users to the risks of addiction, abuse and dependence,” the FDA spokesperson said.

“There is no FDA-approved drug containing, or derived from kratom, and the agency has received concerning reports about the safety of kratom. The FDA is actively evaluating available scientific information on this issue. In addition, FDA has sent numerous letters to firms that have marketed kratom products with unsubstantiated claims that their products can treat opioid withdrawal and addiction and other serious medical conditions.”

Kratom use has been growing in the U.S. as people seek alternatives to opioid pain relievers and other pharmaceutical drugs. Most kratom users say the leaves have a mild analgesic and stimulative effect, similar to coffee.  

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

FDA Targets Websites Selling Illicit Opioids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is trying to put more teeth into efforts to stop the sale of unapproved or misbranded opioid medications online.

The FDA has launched a pilot program with the National Telecommunications and Information Administration (NTIA) that could result in online pharmacies being blocked or having their domain names suspended for selling illicit opioids. The NTIA is a branch of the U.S. Commerce Department that is responsible for telecommunications and information policy issues.

Under the pilot program, the FDA will notify three internet registries – Neustar, Verisign and Public Interest Registry – when the agency sends a warning letter to a website operator for selling opioids illicitly and the operator does not respond adequately within the required time frame. The internet registries could then voluntarily block or suspend the website domains, which would effectively take them offline.

“Stopping abuse of illegal opioids, including those sold online, has been one of President Trump’s top health priorities. The men and women of FDA have worked tirelessly over the years with the private sector and federal partners, like NTIA, to fight illegal online opioid sales,” Health and Human Services Secretary Alex Azar said in a statement.

For now, according to an FDA spokesperson, the pilot program will not target websites selling kratom, an herbal supplement that the agency considers an opioid.

“Websites selling kratom are not being included in this pilot at this time,” the spokesperson said in an email to PNN. “FDA continues to express concerns about kratom, which affects the same opioid brain receptors as morphine and appears to have properties that expose users to the risks of addiction, abuse, and dependence.”

In recent years, the FDA has sent hundreds of warning letters to rogue online pharmacies that sell counterfeit drugs or illegal medication. When they are caught, the websites often reappear under new domain names or move offshore.

‘Our Best Selling Product’

Sometimes the letters are simply ignored. For example, in September 2019, the FDA sent a warning letter to Euphoria Healthcare, which operates an online pharmacy called “Generic Wellness.” The letter warned Euphoria about selling the opioid tapentadol under the name “Aspadol” – a generic version of Nucynta. The FDA considers Aspadol to be an unapproved and misbranded drug, and gave Euphoria 15 days to respond to the letter or face possible civil or criminal charges.

Nine months later, Generic Wellness not only continues marketing Aspadol, it calls the drug “our best selling product” and claims the company is a “well known online pharmacy for selling FDA approved high quality generic medicines.”

The FDA had better luck with a March 2019 warning letter to the online pharmacy “The Don Rx” for selling misbranded versions of the opioid tramadol. That website has apparently been blocked or is no longer operating.  

The FDA’s new pilot program is apparently the result of meetings the agency had with internet stakeholders and registries to discuss ways to collaboratively stop sales of illicit opioids online. As a result of those meetings, Google began to de-index websites named in FDA warning letters, and social media platforms like Facebook and Instagram redirected users looking to buy opioids to a government run help line.

Drug Tests Show Kratom Use Doubled in U.S.

By Pat Anson, PNN Editor

Kratom use in the U.S. appears to have doubled in the last two years, according to a large analysis of urine drug tests by Millennium Health. The first of its kind study also found that nearly 1 out of 4 people who tested positive for kratom were abusing opioids, benzodiazepines or other substances.

Kratom is an herbal supplement that millions of Americans use to self-treat their chronic pain, anxiety, depression and addiction. It comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever.

Millennium Health analyzed over 400,000 urine samples collected from 2017 to 2019, using liquid chromatography mass spectrometry to test for mitragynine and 7-hydroxymitragynine, two alkaloids that are the active ingredients in kratom.

The drug tests were ordered for patients by doctors in primary care, pain management and addiction treatment. As a result, the findings may not represent the typical kratom user.

Positivity rates for kratom doubled over the study period, rising from 0.9% in January 2017 to 1.8% in November 2019. Use of kratom rose in every section of the country, with the highest positivity rates reported in Idaho (4.2%), Montana (2.9%), Colorado (2.3%), Utah (2.3%) and Florida (2.1%).

The American Kratom Association generously estimates that over 15 million Americans use kratom. As interest in the herbal supplement has grown, so have the number of doctors ordering drug tests to see if their patients are using it.

“There are clinicians out there, that are caring for these type patients, that are likely to have kratom users in their population. It’s a small number, about 2 percent or so, but it’s likely increasing,” says Eric Dawson, PharmD, Vice-President of Clinical Affairs for Millennium.

One of the more surprising aspects of the study was how many kratom users were abusing other substances. For urine samples testing positive for kratom, nearly 25% were also found to be positive for non-prescribed opioids and 22% tested positive for non-prescribed benzodiazepines, an anti-anxiety drug.

Methamphetamine, fentanyl, cocaine and heroin were also more likely to be detected in positive samples for kratom versus those that tested negative.

SOURCE: MILLENNIUM HEALTH

Kratom use has been growing in the U.S. as people seek alternatives to opioid pain relievers and other pharmaceutical drugs. Many also use kratom to self-treat alcoholism or opioid addiction.

“You have these two camps, very pro-kratom and very anti-kratom. We purposely tried not to fall into either one and simply answer the questions we were being asked and see what the data is,” Dawson told PNN. “I’m very interested to see what happens to kratom moving forward in the next few years because the benefits are very compelling, but conversely so are the negatives. It’s quite an interesting compound for sure.”  

Most federal agencies take a dim view of kratom. The FDA says kratom is addictive, has opioid-like qualities, and should not be used for any medical condition. The CDC has linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

Although kratom remains legal at the federal level, several states have banned kratom and some counties and cities have enacted local ordinances prohibiting sales.

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

I Can’t Imagine Life Without Kratom

By Kimberley Flink, Guest Columnist

I'm 59, a native Floridian and spent most of my entire life actively outdoors. About five years ago, I woke up and could barely move, my body was wracked with intense muscle pain. I was in tears simply brushing my teeth, taking a shower, holding a coffee cup or even opening a door.

If I had to attempt to describe the pain, it would be similar to doing a triathlon and never practicing a day for it. Every muscle ached and throbbed in constant, chronic soreness. I felt like a little old lady when walking, standing and sitting, with groans of pain to boot.

Finally, after several trips to the doctor, they diagnosed me with fibromyalgia and a series of drugs were prescribed: anti-depressants, muscle relaxers, gabapentin and all the typical prescribed pharma arsenals.

Nothing helped with the pain. Instead they gave me side-effects that ranged from horrid headaches, weird sensations in my body, and the list goes on. So I set out to approach a holistic natural path.

Marijuana made me overeat and I didn't like staying high. I cleaned up my diet, took organic superfoods and spent tons on supplements, all to no avail.

Then a friend recommended kratom. And from the first day of taking it I was literally in tears, thanking God for a respite.

I do not even take the recommended dosage, so as to not overuse it, and I do not take kratom every single day, so I do not become addicted.  On the days I don’t take it, I'm suffering and hardly able to get out of bed.

KIMBERLEY FLINK

I cannot imagine my life without kratom, as I am now able to spend time with my granddaughter, go on short outings and function somewhat normally. I do not get high, overeat and have no ill side effects. It gives me a little energy and dials down the pain level severely. 

It would be a serious injustice to not have kratom available to people like myself, who suffer with chronic pain and do not want the heavy-duty drugs that people get addicted to or take their life by overdosing.

To compare kratom with alcohol, nicotine, opioids or other drugs that can cause death is absurd. I know what addiction is and those who say otherwise are simply abusing kratom. Or they’re using some other black market, knock-off product.

Kratom is the only thing that has given me a good portion of a quality life back. I thank God for it!

Kimberley Flink lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to:  editor@PainNewsNetwork.org. 

Feds Incinerate 28 Tons of Kratom

By Pat Anson, PNN

Over 28 tons of the herbal supplement kratom were recently destroyed by the federal government, the final chapter in a legal battle over one of the largest seizures of kratom in U.S. history.

The U.S. Marshals Office paid a hazardous waste company nearly $30,000 to transport the kratom from South Carolina to Florida, where it was incinerated at an energy-from-waste facility. The kratom had an estimated value of $1 million.

Kratom is a dietary supplement that millions of Americans use to self-treat their chronic pain, anxiety, depression and addiction.  It comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever.

The incinerated kratom was seized in 2018 after FDA inspectors found large quantities of kratom powder and capsules at a warehouse in Myrtle Beach, SC operated by Earth Kratom, a kratom wholesaler and vendor.

At the time, the federal government was engaged in a public relations campaign against kratom, led by then-FDA Commissioner Scott Gottlieb. Federal officials claimed kratom was a risky and addictive substance that should not be used to treat any medical condition.

“Serious concerns exist regarding the effect of kratom on multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom consumption has been linked to neurologic, analgesic and sedative effects, addiction, and hepatic toxicity,” U.S. Attorneys said in a civil forfeiture complaint that led to the kratom being seized.

Kratom can be sold legally in South Carolina and most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions.

“There’s nothing wrong with our facilities or our product,” explained Brian Stall, supervising manager for Earth Kratom. “We were selling a product for human consumption and they didn’t like that.”

Stall told PNN that Earth Kratom’s lawyers were able to persuade a judge to order the kratom returned, but it was seized a second time by U.S. Marshals. The kratom was wrapped in plastic and remained at Earth Kratom’s warehouse, but was off-limits to the company.

“They took all of our product and half of our building at that point,” said Stall. “It was a tough time for us. We’d worked really hard and really believed in the product. It really sucked.”

Earth Kratom’s entire inventory may have gone up in smoke, but it survived the ordeal and remains in business. It sells one of the most popular kratom brands, Trainwreck Kratom, a blend that combines several different kratom strains. PNN’s Crystal Lindell raved about Trainwreck as a pain reliever in a 2018 column.

Scott Gottlieb resigned as FDA commissioner in March 2019 and weeks later joined the board of directors at Pfizer. Although the FDA’s campaign against kratom seems to have quieted since Gottlieb’s departure, an import alert remains in effect that allows FDA inspectors to seize kratom products even “without physical examination.”    

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

Study Finds Kratom Effective for Pain Relief

By Pat Anson, PNN Editor

The herbal supplement kratom is an effective treatment for pain, helps users reduce their use of opioids and has a low risk of adverse effects, according to a new study by researchers at Johns Hopkins University School of Medicine.

The study is based on an online survey of nearly 2,800 kratom users and was funded by the National Institute on Drug Abuse (NIDA). The findings are notable, because they debunk many of the claims made by other federal agencies that kratom has a high potential for abuse and should be banned because of its opioid-like qualities. Kratom is currently illegal in six states, and several cities and counties have enacted local ordinances banning sales.

“There has been a bit of fearmongering, because kratom is opioid-like, and because of the toll of our current opioid epidemic.” said lead author Albert Garcia-Romeu, PhD, an instructor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction.

Banning kratom would be a mistake, according to the researchers, who say kratom actually helps reduce opioid abuse. About 40% of those who participated in the survey said they took kratom to treat opioid withdrawal. Of those, 35% reported going more than a year without taking prescription opioids or heroin. 

“There is a high likelihood that banning kratom or its constituents would compel individuals who are presently using kratom for pain relief or opioid use reduction to return to using prescription or illicit opioids with a known risk of dependence and possible lethal overdose,” Garcia-Romeu and his colleagues reported in the journal Drug and Alcohol Dependence.

Over 91% of those surveyed said they would endorse kratom for pain relief, and about two-thirds would recommend it as a treatment for anxiety and depression.

Kratom ‘Relatively Safe’

Survey participants also completed a checklist to assess whether they had a substance use disorder. Only 2% met the criteria for moderate or severe abuse of kratom, while about 13% met some criteria for a kratom use disorder. That is comparable to about 8% to 12% of people prescribed opioid medication who became dependent, according to NIDA.

“Both prescription and illicit opioids carry the risk of lethal overdose as evidenced by the more than 47,000 opioid overdose deaths in the U.S. in 2017,” says Garcia-Romeu. “Notably there’s been fewer than 100 kratom-related deaths reported in a comparable period, and most of these involved mixing with other drugs or in combination with preexisting health conditions.”

About a third of the survey participants reported having mild unpleasant side effects from kratom, such as constipation, upset stomach or lethargy, which usually resolved within a day. About 10% reported having withdrawal symptoms once the kratom wore off, with less than 2% saying their withdrawal was severe enough to seek medical treatment.

“Although our findings show kratom to be relatively safe according to these self-reports, unregulated medicinal supplements raise concerns with respect to contamination or higher doses of the active chemicals, which could increase negative side effects and harmful responses,” said Garcia-Romeu. “This is why we advocate for the FDA to regulate kratom, which would require testing for impurities and maintaining safe levels of the active chemicals.”

The Johns Hopkins findings are similar to those from a 2016 PNN survey of over 6,000 kratom consumers, in which 98% said kratom was very effective or somewhat effective in treating their medical condition. Over two-thirds rejected the idea of having the FDA regulate kratom, fearing it would lead to higher prices or because it would require a prescription.

While there are inherent problems with online surveys of self-selected kratom users, there is a notable lack of clinical studies that definitively prove whether kratom is effective or harmful — forcing researchers and regulators to rely mostly on anecdotal evidence.

In 2016, the DEA tried unsuccessfully to list kratom as a Schedule I controlled substance, claiming it was an “imminent hazard to public safety.” The CDC has linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

The FDA says kratom is addictive and not approved for any medical condition. The agency has also released studies showing salmonella bacteria and heavy metals contaminating a relatively small number of kratom products.

Garcia-Romeu cautions consumers not mix kratom with other drugs or medications, and to talk with their doctor before taking any supplement.

“Kratom doesn’t belong in the category of a Schedule I drug, because there seems to be relatively low rate of abuse potential, and there may be medical applications to explore, including as a possible treatment for pain and opioid use disorder,” he said.

Kratom Smugglers Face Prison in Asia

By Pat Anson, PNN Editor

If you think kratom’s legal status is under siege in the United States, be glad you don’t live in Southeast Asia. Although the kratom tree (mitragyna speciose) is indigenous to the region and its leaves have been used for centuries as a natural stimulant and pain reliever, possessing kratom could get you sent to prison in some countries. 

Recently two Malaysian men were arrested at a port in Singapore for trying to smuggle several bottles of kratom tea hidden in a truck.

Kratom contains mitragynine and 7-hydroxymitragynine, two alkaloids that are Class A controlled substances in Singapore – which has some of the world’s toughest drug control policies.

If convicted, the men face a minimum of 5 years in prison and 5 strokes with a cane. The maximum penalty in Singapore for importing kratom is 30 years imprisonment and 15 strokes with a cane.

Singapore’s Immigration & Checkpoints Authority (ICA) announced the arrests on its Facebook page, where hundreds of people praised the agency for its diligence.

“Good job! This is why I enjoy Singapore so much,” wrote one poster. 

“Good job ICA for protecting the country,” said another.

SINGAPORE ICA

Decriminalization in Thailand

Kratom has been illegal in Thailand since 1943, but efforts are underway to decriminalize it. Justice Minister Somsak Thepsutin recently formed a committee to consider legalizing kratom-based medicines. If kratom is decriminalized, as many as 10,000 drug offenders in Thailand could have their convictions overturned, according to The Nation.

“I will proceed with this project as soon as possible because this will truly benefit society,” said Somsak, who believes kratom it is not strongly addictive and should not be classified as a narcotic.

"Kratom leaves do not match those characteristics," said the minister. "Those who use them can stop using it easily, and the leaves can be used as herb to relieve pain, fever, dysentery, or diarrhoea. Also, it is better than morphine thirteen times in killing pain.”

Kratom is also used recreationally in Thailand in a cocktail known as “4 x 100,” named after its four main ingredients: kratom leaves, cough syrup, Coca-Cola and ice. 

Indonesia Banning Exports

Over one and a half tons of kratom were recently seized in Turkey at the Istanbul Airport. A drug sniffing dog detected kratom powder in dozens of packages wrapped in plastic. The shipment was heading to the United States from Indonesia and had an estimated street value of $12 million.

“Subject to numerous health warnings, kratom has been banned in most of the countries in the world and is known being highly addictive and linked to numerous deaths,” a local media outlet reported.

Although domestic consumption of kratom is banned in Indonesia, the country is the world’s largest grower and exporter of kratom. Those exports could end in 2024, as Indonesia’s Ministry of Health has called for a 5-year transition period to allow kratom farmers to shift to other crops.

Earlier this year, kratom advocates claimed the U.S. Food and Drug Administration was lobbying the Indonesian government to ban kratom farming. The FDA told PNN the agency “inquired” about kratom’s legal status in Indonesia, but “has not advocated either formally or informally about a change in law in Indonesia or any other country relative to kratom.”

Kratom is illegal in six U.S. states -- Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin – and several cities and counties have enacted local ordinances banning sales. In the other 44 states, kratom is loosely regulated as a dietary supplement, although federal agencies are engaged in a protracted public campaign against its use.

The FDA says kratom is addictive, has opioid-like qualities and is not approved for any medical condition. The agency has released studies showing salmonella bacteria and heavy metals contaminating a relatively small number of kratom products.  Kratom has also been linked to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

Last year the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I controlled substance – alongside heroin and marijuana — which would effectively ban it nationwide, just as it is in Singapore. Kratom is also illegal in Australia, Denmark, Latvia, Lithuania, Poland, Romania, Sweden and the UK.

Kratom vs. Nutmeg: Which Is More Dangerous?

By Pat Anson, PNN Editor

Here’s a trick question for you. Which substance is more dangerous – kratom or nutmeg?

News reports about a recent study that analyzed calls to U.S. poison control centers leave little room for doubt:

“Life-threatening kratom exposures rose by 5000% in 6 years,” is how the Daily Mail reported it.

“Poison Control Centers See Spike in Calls About Kratom Exposure,” was the headline used by WOSU Public Media.

While the headlines are technically accurate, the study published in the journal Clinical Toxicology did not focus solely on kratom. The herbal supplement was one of many naturally occurring psychoactive substances that resulted in over 67,000 calls to U.S. poison control centers from 2000 to 2017.

Marijuana was involved in about half of those calls, followed by plants and mushrooms that act as stimulants or cause hallucinations. Kratom ranked 7th on the list, behind substances like peyote and nutmeg. Yes, nutmeg.

POISON CONTROL CALLS (2000-2017)

1. Marijuana (31,628)

2. Anticholinergic Plants (14,236)

3. Hallucinogenic Mushrooms (10,482)

4. Morning Glory Plants (3,643)

5. Nutmeg (1,962)

6. Peyote (1,717)

7. Kratom (1,631)

8. Kava Kava (1,331)

9. Salvia (622)

10. Absinthe (65)

11. Khat (52)

In most cases, the calls to poison centers involved minor symptoms like upset stomachs or dizziness, but some were serious enough to result in hospitalizations and even deaths. Researchers said marijuana is particularly concerning because it is being sold in candies, cookies and other edibles that a child could get their hands on.

“These substances have been associated with a variety of serious medical outcomes including seizures and coma in adults and children,” said co-author Henry Spiller, director of the Central Ohio Poison Center at Nationwide Children’s Hospital.  “As more states continue to legalize marijuana in various forms, parents and health care providers should treat it like any other medication: locked up, away, and out of sight of children.

Why Did Kratom Calls Spike?

There were only 1,631 calls involving kratom made to poison control centers over an 18-year period. But the numbers started to rise sharply in recent years as more Americans discovered kratom — from 13 kratom calls in 2011 to 682 calls in 2017 — that’s where the 5,000% spike comes from.

The American Kratom Association estimates several million Americans now use kratom to treat chronic pain, addiction, anxiety and other medical conditions.

Side effects from kratom are relatively rare. But researchers say a high percentage of the calls to poison control centers about kratom resulted in hospital admissions and serious medical problems. The chief complaint for many of the calls, according to another study, was that kratom caused agitation, tachycardia (rapid heartbeat), drowsiness, vomiting and confusion.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. Critics say calls to U.S. poison control centers are misleading and a poor choice for research.

“The data drawn from the Poison Control Centers are notoriously unreliable, inasmuch as they are anecdotal reports from the public that are gathered and reported in an unscientific fashion,” said Max Karlin, a spokesman for the Kratom Information & Resource Center. “In the absence of good data, you just end up with a garbage-in, garbage-out situation.”

Kratom has been banned in a handful of states, but is widely available online and in smoke shops. Spiller and his colleagues say it should be regulated in all 50 states.

“The continued rise in kratom usage coupled with the serious medical outcomes identified in our study support the need for federal regulation of kratom along with further research on this public health problem,” they concluded. “While rates of exposure to most natural psychoactive substances decreased during the study period, rates for marijuana, nutmeg, and kratom increased significantly.”

The study offered no explanation for the significant increase in nutmeg calls. Nor did it suggest that nutmeg be regulated.

Nutmeg is a spice known for its pungent fragrance and sweet taste, but in large doses it can also have a psychoactive effect.

As far back as the Middle Ages, people used nutmeg as a medicine and to get high. There is even a page for nutmeg on Reddit, where drug users swap stories and try to figure out the best way to ingest it.

“Do I need to ground them up to a powder or can I just make little pieces and swallow them with water? Can I smoke nutmeg? Can I snort it?” asked a nutmeg newbie.  Most people who tried nutmeg said it made them sleepy, nauseated and wasn’t worth the effort.

While any call to a poison control center is concerning, the number of calls about kratom and nutmeg that came in over an 18-year period pales in comparison to the calls that come in every day about children ingesting hand sanitizers, laundry detergent packets and other toxic products.

Which brings us back to our original question. Is kratom or nutmeg more dangerous?  When used in moderation and with common sense, millions of people will tell you neither one is.

Kratom Advocates Call for End to ‘Leafer Madness’

By Pat Anson, PNN Editor

If you are curious about the herbal supplement kratom and did some research online to learn more about it, chances are you’ve come across some of the scary headlines:

“Warnings Issued on Kratom Use”

“The Herbal Supplement That Could Poison You”

“Kratom Is Unsafe for People’s Health”

“Kratom: Deadly Supplement or Supplementing Death?”

With news coverage like that, you might wonder why anyone would try kratom. But according to the American Kratom Association, there are 16 million kratom users in the United States, most taking it to treat chronic pain, addiction, withdrawal or anxiety.

Why is a popular supplement being demonized in the media? Kratom advocacy groups say many news organizations in the U.S. have succumbed to a collective case of ‘Leafer Madness’ – similar to the ‘Reefer Madness’ over marijuana.

In a media analysis released in May, the industry-funded Kratom Information and Resource Center (KIRC) concluded there was a “tsunami of unfair and unbalanced” reports on kratom.

Ninety-two percent of the nearly 2,500 media stories analyzed by KIRC were found to be negative or unbalanced. Most of the negative coverage was by local media, which was heavily influenced by FDA and CDC reports linking kratom to overdose deaths or comparing kratom to opioids. Those reports were rarely questioned by reporters who didn’t seek another opinion.

This week KIRC followed up on its media analysis by sending a petition to nine media trade organizations asking that kratom be covered more fairly.

“You are in a position to encourage your members to start reporting on the coffee-like herb kratom in a fair and balanced way. Please urge them to tell both sides of the story, seek out the reputable scientists who dispute claims made against kratom, and stop depicting kratom consumers as unsavory characters.

“To date, most ‘reporting’ about the kratom consumed today by millions of American adults without ill effect has been sensationalistic and one-sided, the modern-day equivalent of the irresponsible and inaccurate ‘Reefer Madness’ media depictions that once were used to justify keeping in place restrictions on marijuana and to stigmatize those choosing to consume it.”

The nine media trade groups receiving the KIRC petition are: The American Society of News Editors, National Association of Science Writers, Association of Health Care Journalists, News Media Alliance, Investigative Reporters and Editors, National Newspaper Association, The Association of Magazine Media, Society of Professional Journalists and The National Association of Broadcasters.

“Stop treating kratom like some kind of pinata that you can whack away at as though the rules of journalism don’t apply,” KIRC spokesperson Max Karlin said in a statement.

“Our message to the media is very simple: Get your facts straight about kratom and listen to all voices, not just those with the biggest megaphones. There is a great deal of scientific disagreement about kratom when it comes to such issues as pain management and dependency. All experts should be heard, not just a cherry-picked few who have been lined up by proponents of prohibition.”

The “scientific disagreement” over kratom stems from the fact that so little is known about it – even though it’s been used for centuries in southeast Asia as a natural pain reliever and stimulant.  There have been few clinical studies of kratom to document its risks and benefits — leaving mostly anecdotal reports to rely on.

Still Interested in Learning About Kratom?  

One can find a lengthy and balanced review of kratom that was recently published in the journal Substance Abuse and Rehabilitation.  The authors — two pharmacy professors at the University of Florida and Midwestern University in Arizona — question the claims about kratom causing overdoses, because “causality could not be established in almost all cases because of poly-drug exposures.”

And while reports of kratom addiction “are of serious concern” given the opioid crisis, Oliver Grundmann, PhD, and Charles Veltri, PhD, found no solid evidence that kratom causes dependency.

At the same time, however, they urge kratom consumers to be cautious about be exposed to kratom products that could interact with medications they are already taking.

“The labeling of Kratom products available to consumers needs to follow appropriate regulatory standards as well as quality good manufacturing practices to ensure that consumers who seek out Kratom are not exposed to adulterated or contaminated products,” Grundmann and Veltri wrote. “Health care providers should be trained on the science of Kratom and its clinical implications to assist consumers in making the right choice and avoid herb–drug interactions.”

Researchers Call Kratom a Public Health Threat

By Pat Anson, PNN Editor

The herb kratom poses a public health threat and should not be sold as a dietary supplement, according to a team of researchers who say kratom should be regulated like a prescription drug because it has “opioid-like” qualities.

"Although it is not as strong as some other prescription opioids, kratom does still act as an opioid in the body," said William Eggleston, PharmD, a professor of pharmacy practice at Binghamton University in New York. "In larger doses, it can cause slowed breathing and sedation, meaning that patients can develop the same toxicity they would if using another opioid product.

“Our findings suggest kratom is not reasonably expected to be safe and poses a public health threat due to its availability as an herbal supplement.”

Eggleston is lead author of a recent study published in the journal Pharmacotherapy that looked at the growing number of calls about kratom to U.S. Poison Control Centers. In recent years, millions of Americans have discovered kratom and use it to self-treat chronic pain, addiction, anxiety and depression.

Eggleston and his colleagues identified 2,312 kratom exposures in the National Poison Data System (NPDS) from 2011 to 2018, with 935 cases involving kratom as the only substance.

The chief complaint for many of the calls was that kratom caused agitation, tachycardia (rapid heartbeat), drowsiness, vomiting and confusion. Infrequent but serious side effects included seizure, withdrawal, hallucinations, respiratory depression, coma, and cardiac or respiratory arrest.

KRATOM CALLS TO U.S. POISON CONTROL CENTERS

SOURCE: AMERICAN ASSOCIATION OF POISON CONTROL CENTERS

‘Significant Toxicity’

“Despite kratom’s growing popularity as a safe and natural self-treatment option for patients with OUD, our findings suggest there are concerns for significant toxicity. Reports of kratom exposures to the NPDS are rising and have already been associated with serious opioid toxicities, including seizures, agitation, and death,” researchers reported.

“According to the United States Dietary Supplement Health and Education Act of 1994, herbal and dietary supplements must contain ingredients that are reasonably expected to be safe. Our findings repudiate the idea that kratom meets this criterion. Kratom’s opioid effects put patients at risk for withdrawal, respiratory depression, and death.”

But critics say calls to poison centers are anecdotal, misleading and a poor choice for research.

“The data drawn from the Poison Control Centers are notoriously unreliable, inasmuch as they are anecdotal reports from the public that are gathered and reported in an unscientific fashion,” said Max Karlin, a spokesman for the Kratom Information & Resource Center. “In the absence of good data, you just end up with a garbage-in, garbage-out situation.”

“All the Eggelston paper shows is that the anti-kratom bias is deeply entrenched in conventional medical, pharmacological and government sectors,” said Jane Babin, PhD, a molecular biologist, patent lawyer and consultant to the American Kratom Association (AKA). “It seems to be more of the same unscientific attack on kratom. I don’t see anything in this that warrants their conclusion.

“AKA now estimates that there are 16 million kratom users in the U.S. based on data from Indonesia on how much kratom is exported to the U.S. annually. 2,312 exposures out of 16 million users is a pretty low percentage of users who have anything to report to poison control.”

The 2,312 calls about kratom over an 8-year period pale in comparison to calls about other substances. In the first six months of this year alone, over 13,400 calls were made to U.S. poison centers about children ingesting hand sanitizers or laundry detergent packets.

Kratom Scheduling

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. As a dietary supplement, kratom is loosely regulated in the United States, although federal agencies are engaged in a protracted public campaign against its use.

The FDA says kratom is addictive, has opioid-like qualities and is not approved for any medical condition. The agency has also released studies showing salmonella bacteria and heavy metals contaminating a relatively small number of kratom products. 

The CDC recently linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

The Department of Health and Human Services (HHS) has recommended to the DEA that kratom be classified as a Schedule I controlled substance – alongside heroin and marijuana — which would effectively ban it nationwide.

“At some level, we do need to have better control over it,” says study co-author Lewis Nelson, MD, a Professor of Emergency Medicine at Rutgers New Jersey Medical School. “We know that (kratom) has two big uses out there. One of them is for people to get high and the other one is to treat opioid withdrawal. Those are the real reasons people use it.

“Whether its an opioid or not an opioid, people use it do things that they would typically do with opioids, like pain, get high, and treat withdrawal. I think empirically we know it has enough of an opioid-like character that it’s being marketed and used that way.”

Lewis said kratom should be scheduled as a controlled substance, but not under Schedule I. He thinks it may be more appropriate to classify kratom as a Schedule II or III drug, where it could still be available by prescription.

“I would like to see that. If they could show this drug has benefits and we could understand and moderate the risk, I don’t see why it couldn’t be used like any other drug,” said Lewis, who is a longtime critic of opioid prescribing.

“Let’s create a safe product and let’s get it appropriately scheduled. Have it available by prescription. I don’t have a problem with that.”

— Dr. Lewis Nelson

“Prove it works. Let’s create a safe product and let’s get it appropriately scheduled. Have it available by prescription. I don’t have a problem with that.”

But getting kratom approved by the FDA as a prescription drug would require years of clinical studies. Pharmaceutical companies may be reluctant to fund research on a natural substance that they may not be able to patent. And kratom users, long accustomed to buying it online or in smoke shops, dislike the idea of needing a doctor’s prescription.

In a 2016 PNN survey of over 6,400 kratom users, nearly 98 percent said they wanted kratom to remain available as a dietary supplement.  Over 70 percent said pharmaceutical companies should not be allowed to produce kratom-based drugs.  And nearly three out of four dispute the notion that it’s possible to get high from kratom.  

Lewis remains skeptical that people are not using kratom recreationally and that it should remain on the market as a dietary supplement.  

“I find it a little disingenuous to say we should leave this potentially unsafe drug on the market unregulated, just because some people already use it,” he told PNN.