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.

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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.

Indonesia May Ban Kratom Exports

By Pat Anson, PNN Editor

A possible ban on the growth and export of kratom in Indonesia is raising alarm among kratom users in the U.S. and around the world.  About 95% of the world’s supply of kratom comes from Indonesia, where the herbal supplement has become a lucrative cash crop.

Kratom leaves are harvested from 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 started using kratom to treat pain, addiction, anxiety and depression.

Kratom advocates say the U.S. Food and Drug Administration – which opposes the use of kratom for any medical condition – has been lobbying the Indonesian government to ban kratom farming. Current plans by the Indonesian Ministry of Health call for a 5-year transition period to allow kratom growers to shift to other crops.

“If this ban is allowed to go into effect, it will effectively end consumer access to kratom in the United States, and the FDA won’t have to do anything more to declare victory in the War on Kratom,” said C. M. “Mac” Haddow, a lobbyist for the American Kratom Association (AKA), a group of kratom vendors and consumers.

“Even if some black-market kratom gets into the United States after the Indonesian ban goes into effect, it will be so expensive that only the uber-rich will be able to afford it. And it will likely be extremely dangerous to consume because there will be no standards on growing, harvesting, and shipping.”

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FDA Denies Involvement

An FDA spokesman said the agency has “inquired” about kratom in Indonesia, but denied making any effort to have it banned.

“The FDA has inquired to understand the current status of kratom under Indonesian law. However, the FDA has not advocated either formally or informally about a change in law in Indonesia or any other country relative to kratom,” the spokesman said in an email to PNN.

The AKA sent a delegation to Indonesia last month to meet with the Ministry of Health and other government officials. Among the attendees was Duncan Macrae, the founder of Kratom.com and one of the first commercial growers of kratom in Indonesia. Macrae told PNN the initial meeting went well.

“When we left Jakarta we were given the green light that there would always be a legitimate path to export kratom even though the Indonesian government will almost definitely regulate and make kratom illegal for domestic use in Indonesia,” Macrae wrote in an email. “Unfortunately, since there was some (in my opinion) unnecessary outreaching to other departments such as the Agriculture & Quarantine department and also the department of trade, this has stirred up another hornet’s nest.” 

According to the AKA, the Ministry of Agriculture sent a memo in the past week to various agencies in the Indonesian government recommending the ban on kratom be formalized at all levels of government.  

Macrae fears that kratom will also be classified as an illegal controlled substance in Indonesia, which would effectively ban its growth and export.  

Was the FDA involved? For sure yes! Unfortunately, this went through the U.S. embassy in Jakarta as well.
— Duncan Macrae, Kratom Supplier

“This means it has no scientific or medicinal use and will even prevent further research from being done on the plant in Indonesia,” said Macrae. “Was the FDA involved? For sure yes! Unfortunately, this went through the U.S. embassy in Jakarta as well.” 

A leading Indonesian politician called on the government to ignore the “world health mafia” and conduct research on the risks and benefits of kratom before banning it.

"Once again the government does not play a ban without doing deep professional research. It is tantamount to throwing away the nation's own assets. In the end Indonesia will only be an importer of finished products from kratom leaves," Daniel Johan, Deputy Chairperson of the House of Representatives, told a local news agency. "Indonesia must master its downstream products so that it is truly beneficial for the people of Indonesia and the world, so that we do not even enter the format of world health mafia war."

Kratom is already banned for domestic use in Indonesia, although the export of raw kratom product is allowed. In 2016, about 400 tons of kratom were shipped every month from Indonesia’s top growing region -- worth about $130 million annually, according to a report from Agence France-Presse. Most of those exports went to the U.S.

The FDA has linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths. The FDA has also found salmonella bacteria and heavy metals in a relatively small number of kratom products. 

Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide. Currently, the DEA doesn't even list kratom in its annual report on drug threats. 

The AKA is planning to send another delegation to Indonesia this month to lobby against a kratom ban.

Kratom Helps Me with Pain and Addiction

(Editor’s note: The author of this column is using the pseudonym “Marc Smith’ because he fears his employment and healthcare could be jeopardized if his true identity were known.)

By Marc Smith, Guest Columnist

I have had a long and treacherous battle with health problems and substance abuse. Starting at age 14, I was diagnosed with multiple reoccurring bone tumors on my right leg below the knee. This led to six major surgeries; three for tumor removal and three for MRSA bacterial infection treatment and debridement.

My knee is completely damaged from the tumor destroying the top of my tibia and the bacteria completely eating away at my meniscus and cartilage. I have severe chronic and acute pain in that leg. I am not a candidate for a knee replacement due to the bone being too damaged and it is not a stable site for an artificial joint.

I have also been in a severe car accident that lacerated my left arm, broke the fibula in my left leg and tore the meniscus in my left knee.

The treatment of these ailments came with a lot of prescribed narcotic pain medications on a regular basis from age 14 on. My tolerance to these medications grew astronomically over 15 years until they stopped working effectively.

I eventually was buying OxyContin on the street and abusing it heavily. This led to IV heroin and cocaine use, and the loss of anything of real value I had.

I struggled with this crippling addiction for 18 years. I tried methadone, Suboxone, Vivitrol and complete abstinence -- with no significant success with any of them. Finally, I tried a strong 12-step recovery program. It worked temporarily, but the physical pain would become too much and I would relapse on opiates.

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A year ago, I found kratom and decided to try it for pain relief. It helps me with pain, helps me sleep, curbs craving, and allows me to function and participate in daily life without being in extreme pain. I do not have extreme tolerance building problems with kratom like I did with opioids. The side effects are extremely minor and do not impair my judgment or ability to function.

I am up at 4:30 AM every day and at the gym by 4:45 cycling for an hour. I have found the recumbent bike does not hurt my leg that badly. I lost weight due to exercise and diet changes that kratom helped me make. I am much more positive about taking care of myself and am able to be present for life.

My pain hasn’t completely vanished, but it is manageable due to kratom. My spiritual growth has been a big factor as well in my 12 months of sobriety. These two things working in harmony have literally saved my life. I am a completely different person and my family has their son back.

I do not want to die and the fact that this harmless plant is being targeted makes me scared for my life. Let’s focus on rehabilitation and recovery methods. Let’s focus on illicit fentanyl and other synthetic chemicals, not a natural botanical. Please, take a step back and look at kratom success stories like mine.

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Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Warns Kratom Vendors

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued two more warning letters to kratom vendors – Cali Botanicals of Folsom, California and Kratom NC of Wilmington, North Carolina – for making unproven claims that kratom can treat pain, addiction, depression, anxiety and other medical conditions.

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 -- including many who have lost access to opioid medication -- and found it to be an effective treatment.   

The FDA, however, considers kratom an unapproved drug that shouldn't be used to treat any medical condition.

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” said acting FDA Commissioner Ned Sharpless, MD.

“As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.”

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What makes kratom dangerous? Sharpless cited FDA studies that found salmonella bacteria and heavy metals in 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.

The FDA said Cali Botanicals and Kratom NC were using websites and social media to make unproven claims about kratom's ability to treat medical conditions. Cali Botanicals, for example, makes these claims about kratom's benefits:

  • “Kratom is able to reduce the pain levels that reach the brain in a way that’s very similar to opioid drugs.”

  • "Kratom is seen as life-saving by former addicts, who found kratom to be the only way they could overcome their addictions."

  • “Consumption of kratom can reduce pain and swelling to an injury.”

  • “Addicts can wean themselves off of their addictions by replacing their drugs with kratom. It has similar effects as opioids, but without the same dependency. Kratom also helps with the withdrawal symptoms.”

  • “Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction."

  • “Some researchers have even claimed that kratom can protect you against cancer!”

With the exception of that claim about preventing cancer, those are the same benefits that many kratom users report anecdotally.

"For over two years now I have enjoyed drinking my kratom tea a couple of times a day. It helps promote my mood and energy like a cup of coffee would. The tea also relieves my aching joints and muscles, making my chronic fatigue and pain much more bearable," Kim DeMott wrote in a recent PNN column.  

"Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics. And I am devastated that the FDA is working to ban the only thing that has helped me in the past 28 years," fibromyalgia sufferer Mary Ann Dunkel wrote in another guest column.

Kratom has been banned in 6 states and dozens of counties and cities have enacted or are considering their own bans. Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide. Currently, the DEA doesn't even list kratom in its annual report on drug threats. 

Kratom Saved My Life

By Kim DeMott, Guest Columnist

I was diagnosed with lupus in 2013 after spending several years with unexplained chronic pain, debilitating fatigue and other awful symptoms. Lupus was the first of many chronic conditions that I would be diagnosed with in coming years, including fibromyalgia, Sjogren’s syndrome, osteoarthritis, osteoporosis, carpal tunnel syndrome, migraines, endometriosis, interstitial cystitis, chronic fatigue, chronic pain, anxiety and depression.

To treat these conditions, I was prescribed 28 different medications a day, including massive amounts of powerful opiates like oxycodone, hydrocodone and morphine, along with high doses of benzodiazepines such as Ativan, Xanax and Klonopin.

Even though I was taking all these medications, I was still in pain, had bad anxiety and no quality of life. I was housebound and practically bedridden (or at least couch-ridden) most days.  I had to use a cane, walker and even the walls in my house to walk on the really bad days, which is no way for a young woman and mother of two to live.

My health became so bad that in the fall of 2014 my doctors labeled me permanently disabled and told me to get in-home support services and file for SSI. I was only 29 years old.

I would have to tell my kids that mommy was in too much pain and too tired to take them to the park, play with them, pick them up, take them to school or be involved in any of their activities. This caused me and them to miss out on precious time and memories we can’t ever get back.

I couldn’t cook, clean, drive, go to the store or even go for a quick walk. They would see and hear me hiding in the bathroom or bedroom crying from the pain and the feeling of failure I felt as their mom.

I couldn’t take a shower, brush my teeth and get dressed in the same hour because I would have to rest after every task I did. Getting dressed consisted of putting on clean pajamas, because that’s the only thing that wouldn’t hurt to wear. I became isolated and depressed. I stopped answering my phone, texts, messages and emails.

KIM DEMOTT

KIM DEMOTT

The medications that the doctors put me on made me gain a ton of weight and made me feel incredibly dizzy, sleepy, forgetful, sick to my stomach and like I was in a fog. These side effects led to even more medications being prescribed, which meant more pills to add to the already huge amount I took daily. I was so depressed and hopeless that I actually attempted suicide a few times.

For over two years now I have enjoyed drinking my kratom tea a couple of times a day. It helps promote my mood and energy like a cup of coffee would. The tea also relieves my aching joints and muscles, making my chronic fatigue and pain much more bearable.  

I am in no way cured and my pain is not completely gone, it never is and never will be. But the discomfort is down to a level that I can deal with, live with and function at. I still have bad days, but they are nowhere near as frequent or as bad as they used to be.  

Kratom has greatly improved my quality of life and dramatically changed it for the better. I’m not spending every day on the couch or in bed anymore and my kids have their mom back. We are doing so much more together.

Not only are my kids happy, but so are my fiancé, family and friends. Everyone tells me they have seen a huge change in me and that I am much more like the old me, which is something I have longed for since everything started. For the first time in years I don't feel like a prisoner in my own body and like my chronic illnesses and pain control me.

I am healthier, happier, take better care of myself and eat better. I’ve also been able to lose weight since I can cook and exercise again because I have better mobility. I even feel confident that I will be able return to work again someday soon and plan on returning to school this year.  

I look forward to each day and excited for what the future will bring. Most importantly, I am setting a better example for my kids. All thanks to this plant. Kratom has truly not only saved my life but also given me renewed hope. Without this plant I do not believe I would still be alive today.  

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Kim DeMott lives in California with her two children.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Fibromyalgia Stole My Life, Kratom Gave It Back

By Mary Ann Dunkel, Guest Columnist

Fibromyalgia stole my life more than 28 years ago. I have severe chronic pain and fatigue that limits my activities of daily living. Unless you have experienced unrelenting severe pain 24 hours a day, you cannot know the horror of it.

I have been prescribed more pharmaceuticals than I can remember and suffered damaging side effects from them. I've participated in psychotherapy, aqua therapy, multiple pain management programs, acupuncture and hypnosis. None of these modalities brought me relief and for quite some time I was bedridden and dependent on family for care.

My doctors have prescribed me morphine, fentanyl, oxycodone, tramadol and other medications to control the pain. None of them worked for very long and I could see these prescriptions were going to lead to addiction. Often, I weaned myself off them and suffered through terrible withdrawal because the small amount of relief they gave was not worth the risk of addiction or overdose death. Bottom line is these narcotics were not effective in treating my chronic pain.

There were times when I thought about taking my life because I just couldn't get a break from the pain and didn't think I could take it any longer.

Then a friend introduced me to kratom. She had been consuming it for more than 10 years without side effects or becoming addicted to it. I started my own journey consuming kratom.

Kratom is not a drug. It is a dietary supplement. It does not heal any disease, but it has certainly improved my quality of life. I am having pain free days and my energy level is greatly improved. Kratom has restored my ability to have a normal life and I can enjoy all sorts of activities that make my life rich and full.

Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics. And I am devastated that the FDA is working to ban the only thing that has helped me in the past 28 years.

MARY ANN DUNKEL

MARY ANN DUNKEL

I am sick to death of reporters parroting the lies from the FDA and CDC. I implore you. The studies they have done are full of inaccuracies and half-truths. Independent studies of the autopsies in the so called kratom deaths have shown the victims had multiple medications in their systems. They also included a death caused by gunshot.

Eight leading scientists have studied kratom and found it to be safe. It has been used for hundreds of years without problem. It is not an opioid; it is related to the coffee plant. It does attach to the same receptors in the brain as opioids, but so do many other substances such as chocolate and milk.

I would suggest to you that the FDA wants it banned because it is cutting into Big Pharma's financial bottom line. People are finding the help they need without costly and deadly pharmaceuticals. I fear that if kratom is banned this country will see an epidemic of self-inflicted deaths by people who have no hope. Kratom would become a black market substance due to overreach by the government to protect the monies they get from pharmaceutical lobbies.

Please investigate these facts and do the right thing. Do a story on the positives of kratom.

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Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Kratom Gave Me Hope

By Dijon Evans, Guest Columnist

I have taken kratom for 2 years now. I was cut off of my pain meds, after 40 years of proper and adhered to treatment.

There was no taper. No discussion. No warning. My pain management doctors just stopped treating all chronic pain patients and, shortly after, all of their terminal cancer patients.

I have full body Complex Regional Pain Syndrome (CRPS), osteomyelitis, osteoporosis, neuropathy, sepsis, and two pulmonary embolisms.  I’ve had 3 amputations and have an artificial hip. My other hip needs replacement, as does my only knee. My spinal vertebrae are either broken, fractured or collapsed.

I've been having my jawbones ground on, drilled into and screwed together, all with no pain medication because of the panic caused by the CDC guideline, DEA enforcement and imprisonment of doctors.

Two years ago, I was leaving my home (after being bedridden for over 10 years) and asked for help getting into my wheelchair. I was on my way out the door to end my own life.

After being abandoned by the medical profession and my government, I lost all hope. I had no quality of life. And I sure as hell wasn't going to be tortured.

That's when I took my first bit of kratom. When my care provider, my boyfriend, showed up later that day, we both cried. He knelt beside me as I was sitting on the couch. Not in bed. Not begging for mercy. But sitting on the couch, smiling.

Yes, I am still terminal. Yes, I have bad days and flare ups. My doctors know I take kratom, follow me and cannot believe that when they see me, for the most part, I am smiling. I push my own wheelchair into my appointments.

DIJON EVANS

DIJON EVANS

I have blood work each month. No, I am not cured. But I now have hope.

My daughter and grandkids are happy to see me, not dreading it. I'm not in the hospital or ER as much. I have a little bit of quality of life -- while I can.

Is this really too much to ask?

I've done my research. I am educated. I'm an intelligent person. A grandma, a daughter, sister, niece, cousin, a mother, a significant person in several lives. I am important. I do matter.

I don't use much kratom, but if I was asked to change the amount and manner and participate in a clinical trial, I would gladly do so in order for the millions who may benefit and have benefited from it.

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Dijon Evans lives in California.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

House Panel Seeks Clinical Trials of Kratom

By Pat Anson, PNN Editor

At a time when several states and cities have banned kratom, a powerful congressional committee is recommending that the herbal supplement be studied in clinical trials because of its “potential promising results” in treating chronic pain.

In a report to Congress, the House Appropriations Committee recommends that the National Institutes of Health (NIH) conduct research on whether kratom can be used as an alternative to opioids in treating pain.

“The Committee requests that NIH expand research on all health impacts of kratom, including its constituent compounds, mitragynine, and 7-hydroxymitragynine. The Committee is aware of the potential promising results of kratom for acute and chronic pain patients who seek safer alternatives to sometimes dangerously addictive and potentially deadly prescription opioids.”

The committee also recommended that the Agency for Healthcare Research and Quality (AHRQ) spend $3 million on clinical trials of kratom and cannabidiol (CBD) as alternatives for treating pain, and that the trials be conducted in “geographic regions hardest hit by the opioids crisis.”

The panel said it was concerned that the continuing classification of cannabis as a Schedule I controlled substance was stifling research “at a time when we need as much information as possible about these drugs.”

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“The Committee notes that little research has been done to date on natural products that are used by many to treat pain in place of opioids. These natural plants and substances include kratom and cannabidiol (CBD). Given the wide availability and increased use of these substances, it is imperative to know more about potential risks or benefits, and whether or not they can have a role in finding new and effective non-opioid methods to treat pain.”

The committee said the current state of pain management in the U.S. is “often inadequate for many patients” and that additional treatments were needed. It asked that Congress be given an update on the development of non-opioid chronic pain therapies in the next fiscal year.

To be clear, the 346-page report by the House committee is an ambitious “wish list” of hundreds of various projects that may or may not be included in a final congressional spending bill.  But the inclusion of funding for kratom research is significant, given the campaign against kratom by some public health offiicials.

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 as a daily treatment for pain, addiction, depression and anxiety.  

Although kratom is not an opioid, health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition. Last month the CDC said kratom was listed as the cause of death in at least 91 overdoses and the FDA said it discovered dangerous levels of heavy metals in dozens of kratom products.

Kratom has been banned in 6 states and dozens of counties and cities have enacted or are considering their own bans. Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide.

Ironically, HHS oversees both the NIH and AHRQ, the same agencies the House Appropriations Committee wants to fund for kratom research.   

More Overdoses Blamed on Kratom

By Pat Anson, PNN Editor

A new analysis by the Centers for Disease Control and Prevention lists the herbal supplement kratom as the cause of death in at least 91 overdoses in the U.S. from 2016 to 2017.  Multiple substances were involved in the vast majority of those cases, with over half of the deaths also linked to fentanyl, a synthetic and potent opioid that has become a scourge on the black market.

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 kratom has grown in popularity in the U.S. as a treatment for chronic pain, addiction, depression and anxiety.  

Although kratom is not an opioid, public health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition.

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In the new study, CDC researchers analyzed over 27,000 fatal overdoses in 27 states between July 2016 and December 2017. Kratom was determined to be the cause of death by a medical examiner or coroner in 91 overdoses, with multiple substances detected in all but seven of them.

Heavy Drug Use

Most of those who died were apparently heavy drug users. In nearly 80 percent of the kratom-involved deaths, the decedents had a prior history of substance misuse and 11% had survived a previous overdose.  Fentanyl or fentanyl analogs were co-listed as a cause of death in 56% of the kratom-involved deaths. Heroin was co-listed in about a third of the kratom cases, followed by benzodiazepines (22%), a class of anti-anxiety medication, prescription opioids (20%) and cocaine (18%).

“I’m actually pleased that they are recognizing that when kratom is present in a decedent, it is usually with other substances. Instead of blaming kratom as the cause of death, it points to polysubstance use,” said Jane Babin, PhD, a molecular biologist and patent attorney. “If someone takes a lethal dose of fentanyl plus kratom, it is unreasonable to conclude that kratom was the cause of death.  The same could be said of a lethal dose of fentanyl plus anything else – cannabis, coffee, Tylenol, etc.  This is the same situation in many ‘opioid related’ deaths, where multiple substances are present.”

Babin has worked as a consultant to the American Kratom Association, an advocacy group of kratom vendors and consumers. She has disputed previous reports of kratom overdoses – attributing them to faulty lab tests and inexperienced coroners.

“When a coroner can’t find an obvious physical cause of death, they pin the death on kratom even though they don’t have a link between the cause and manner of death and what is known about kratom pharmacology,” Babin wrote in an email to PNN. “I think the bigger question that CDC and FDA need to address is why do these people take so many different substances, including prescription medications?  

“The answer is not simple and there is no quick fix.  It is easier to blame kratom or opioids and focus on those instead of addressing the complex problems of pain, mental illness and the circumstances of life that lead people to take multiple substances.  At least they ‘look’ like they are doing something.”

It was another CDC report in July 2016 that laid the groundwork for an attempted ban on kratom. The report called kratom "an emerging public health threat" due to a modest increase in the number of kratom-related calls to poison control centers. The following month, the Drug Enforcement Administration tried to schedule kratom as a controlled substance, something the agency backed away from after a public outcry.

Last week the Food and Drug Administration released a laboratory analysis that found dangerous levels of heavy metals in over two dozen kratom products. However, the agency did not consider the finding significant enough to order a recall. Kratom has never been listed as dangerous substance in the DEA’s annual National Drug Threat Assessment.

FDA Finds Unsafe Levels of Heavy Metals in Kratom

By Pat Anson, PNN Editor

The American Kratom Association’s new certified vendor program has gotten off to an inauspicious start. Kraken Kratom, the first vendor to qualify under the AKA’s Good Manufacturing Standards (GMP) program, has been flagged by the Food and Drug Administration for having dangerous levels of heavy metals in some of its products.

The FDA this week released the final test results on 30 kratom products found to contain levels of lead and nickel considered unsafe for daily human consumption. Five of the 30 samples that tested positive came from Kraken Kratom or one of its affiliated vendors.

“The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake,” the FDA said in a statement. “Based on these test results, the typical long-term kratom user could potentially develop heavy metal poisoning, which could include nervous system or kidney damage, anemia, high blood pressure, and/or increased risk of certain cancers.”

Ironically, last month Kraken Kraken became the first company to receive the AKA’s seal of approval as a certified GMP vendor. To qualify, participants must undergo a third-party audit and inspection of their manufacturing and packaging facilities.   

The company said in a statement posted online that it was never contacted by the FDA about the heavy metal findings or told to take its kratom products off the market.

“Kraken has no information regarding the samples the FDA used in their tests, including when or how the FDA acquired our products or when they tested the samples they obtained,” the statement said.

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This isn’t the first time Kraken Kratom has come under FDA scrutiny. Its parent company, PDX Aromatics of Portland, Oregon, recalled thousands of kratom packages last year after samples tested positive for Salmonella bacteria. The company believes the samples that tested positive for heavy metals may have come from an FDA inspection in March, 2018.

“If these samples are from that investigation, their product lots were pulled from the market over 12 months ago as part of the extensive recall we did in cooperation with the FDA. Further, it would indicate that the FDA was rehashing old information, not in an attempt to protect the public, but as a way to target and further stigmatize kratom,” the company said.

In recent years, millions of Americans have discovered kratom, an herb grown and used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and what country it came from are often unknown. Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

That’s one of the reasons the AKA launched its GMP certification program. The organization said it wanted to protect kratom consumers from “unscrupulous vendors using sloppy manufacturing procedures” and those who adulterate kratom to boost its potency by adding substances like fentanyl or morphine.

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But under the AKA’s certification program, no kratom products are actually tested for Salmonella bacteria, heavy metals, fentanyl or any other foreign substances.

“No, absolutely not. That is not our function,” AKA President Dave Herman told PNN. “The audit does not inspect the products. The audit inspects the procedures in place to manage the facility.”

Herman says third party auditors hired by the vendor and approved by the AKA only inspect manufacturing procedures — not the kratom itself. He declined to comment on the FDA’s discovery of heavy metals in Kraken Kratom products.

“I have no way of knowing when samples were taken or under what conditions they were taken,” he said. “Was it prior to an inspection? After an inspection? And without that knowledge I’m not sure I can say anything intelligent,” Herman said.

A handful of states have banned kratom and there is speculation the Drug Enforcement Administration will try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. FDA commissioner Scott Gottlieb, MD – who leaves office today -- has also mounted an extended public relations campaign against kratom.

"Over the last year, the FDA has issued numerous warnings about the serious risks associated with the use of kratom, including novel risks due to the variability in how kratom products are formulated, sold and used both recreationally and by those who are seeking to self-medicate for pain or to treat opioid withdrawal symptoms,” Gottlieb said in a statement.

“Data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse. The findings of identifying heavy metals in kratom only strengthen our public health warnings around this substance and concern for the health and safety of Americans using it."