Tag Archives: Schedule 1

11/12/19

Kratom Has Benefits and Risks

© AndreyPopov | stockfresh.com

The State of Ohio Board of Pharmacy (BOP) voted to classify kratom as a Schedule I controlled substance alongside heroin, LSD and other substances. “The board concluded kratom has a high potential for abuse, has no accepted medical use, isn’t safe to use in medical treatment and poses a public health risk.” This led to efforts from pro-kratom organizations, such as the American Kratom Association (AKA), to oppose the scheduling. Instead of a ban, it recommended regulation that would make it illegal for minors, require product labeling, and regulate for quality and purity. Then on August 9, 2019, after a public hearing, the state Board delayed that action in order to review testimony presented

Hundreds of people showed up to give testimony at the public hearing on August 5th. One man, in constant pain after three open heart surgeries, said the pain caused him to miss time with his family. “Being a part of my kid’s life is important to me so I mean, it killed me not to be able to attend stuff.” He said his life was changed when he found kratom as he was once again able to attend his son’s football games, pain free. “Honestly it’s sad and pretty pathetic that our government, or the pharmacy board would be pushing so hard to ban it and it doesn’t make any sense.”

The AKA held a press conference with a John Hopkins University professor, A Utah State Senator, an Arizona State Representative and a Georgia State Representative all urging the Ohio BOP to withdraw its proposed ban on kratom.  The Board decided “to put the kratom ban in a To Be Refiled (TBR) status and it will not be the subject of a Hearing before the Joint Committee on Agency Rule Review (JCARR) on Monday.” When the BOP announced the delay before baning kratom, the American Kratom released the following statement:

The American Kratom Association is deeply grateful to the Ohio Board of Pharmacy for listening to the pleas of the hundreds of Ohioans who provided testimony at the Public Hearing today, and responding to the thousands of email testimony provided by those who could not attend the Hearing in person. The decision to put this proposed ban on kratom in the “To Be Refiled” status will provide the opportunity for the Ohio Legislature to consider the Kratom Consumer Protection Act that Representative Gary Scherer intends to file in the coming week.  That legislation protects consumers and provides an appropriate regulatory framework to ban adulterated and mislabeled kratom products that are responsible for the deaths and adverse health impacts from using kratom laced with dangerous chemicals and opioids.  The AKA will work closely with the Board of Pharmacy and the Ohio Legislature to enact these regulatory schemes to protect consumers.  Utah, Arizona, Georgia, and Nevada have already enacted the Kratom Consumer Protection Act, and it is being considered in another dozen states currently. Our deepest appreciation to policy makers in Ohio who listened, understood, and stood with Ohio residents to allow consumers to use this plant for their health and well-being.

The BOP has been working on the process to make kratom a Schedule I controlled substance since September of 2018. Now that final stage in the scheduling process will have to wait until after the board’s September meeting. The delay could potentially allow Ohio lawmakers to regulate, rather than ban kratom. Rep. Gary Scherer said he’s filing a bill to regulate kratom based on regulations passed in Utah. “This will give the Board time to review all testimony at its September meeting and assess potential new legislation that was introduced on the matter.” Kratom advocacy groups can look on the delay by the Ohio Board of Pharmacy as a temporary victory, but despite the many positive testimonials at the hearing, there are serious legitimate concerns with kratom.

If you are worried about the risks of unscheduled or unregulated kratom, placing it as a Schedule I controlled substance may ultimately backfire by creating too many bureaucratic hurdles for sound, reliable kratom research to get over. Given the accumulating evidence of the potential risks with kratom, the above-proposed legislative regulation also seems to be too loose. The monitoring of kratom use and sales could be tightened through legislation, but let’s be sure to do the research and not make a decision based upon the political pressure of advocacy groups. Henry Spiller, the director of the Central Ohio Poison Control Center, said: “There’s a general feeling, I think, that this is a natural substance, so it is safe. But we need to get across there are risks with this.”

Within its rationale to schedule kratom, the BOP cited studies suggesting that kratom users can develop a dependency on the drug and asserted it had “no acceptable medical use in treatment,” another requirement for Schedule I classification. This claim is based on an FDA report that underscored kratom’s potential for abuse. Using the Public Health Assessment via Structural Evaluation (PHASE) methodology, the FDA concluded that the 25 most prevalent compounds in kratom “have the most structural similarities with controlled opioid analgesics, such as morphine derivatives;” 22 (including mitragynine) of the 25 compounds in kratom bind to mu opioid receptors. “This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).” The FDA Commissioner Scott Gottlieb said he was concerned with the use of kratom to treat opioid withdrawal, saying there was no reliable evidence to support it.

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.

Commissioner Gottlieb went on to say the FDA has been monitoring the use of kratom for several years and placed kratom products on an import alert to prevent them from entering the country illegally. He said these actions were taken on a body of academic research that suggested there could be harm associated with its use. “And we are not alone in our evaluation and our public health concerns. Numerous countries, states and cities have banned kratom from entering their jurisdictions.” Dismissing FDA concerns as disinformation and accusing it of using bad science to justify scheduling kratom seems to be itself disinformation.

There was a paper published in the July 2019 issue of the journal Pharmacotherapy, “Kratom Use and Toxicities in the United States.” It was a retrospective study of data reported to the National Poison Data System. The review was conducted to determine toxicities associated with kratom use in the United States “in order to provide insight into its safety as a dietary supplement.” The authors concluded kratom use was associated with significant toxicities. They said their findings suggested kratom could not reasonably be expected to be safe and it posed a public health threat due to its availability as an herbal supplement. The results of the study were:

A total of 2312 kratom exposures were reported, with 935 cases involving kratom as the only substance. Kratom most commonly caused agitation (18.6%), tachycardia (16.9%), drowsiness (13.6%), vomiting (11.2%), and confusion (8.1%). Serious effects of seizure (6.1%), withdrawal (6.1%), hallucinations (4.8%), respiratory depression (2.8%), coma (2.3%), and cardiac or respiratory arrest (0.6%) were also reported. Kratom was listed as a cause or contributing factor in the death of four decedents identified by the county medical examiner’s office.

The lead author of the study, William Eggleston, said although kratom was not as strong as some prescription opioids, it still acted as an opioid in the body. “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. It is also reported to cause seizures and liver toxicity.” While kratom may have a role in treating pain and opioid use disorder, but more research was needed on its safety and efficacy. Eggleston and his team are working to better assess how many people are actually using kratom and if the risk for toxicity changes contingent with the dose of kratom taken.

Making kratom a Schedule I controlled substance will obstruct research into its potential medical uses. If “Kratom Saves Lives,” as the t shirts worn by AKA supporters at the press conference claimed, then it should be regulated it in a way to restrict indiscriminate availability because of adverse effects like those described above. Kratom regulation is needed for more than just to protect consumers from “adulterated and mislabeled kratom products that are responsible for the deaths and adverse health impacts from using kratom laced with dangerous chemicals and opioids.” There are legitimate safety concerns with kratom and the FDA’s ability to regulate it are currently limited because as a dietary, supplement, it is not subject to the same safety regulations as FDA-approved drugs.

A CDC report from 2016 said kratom was “an emerging drug of concern.” Published case reports associated kratom with psychosis, seizures, and deaths. The report study said 24.5% of the reports on adverse events were for minor complications; 41.7% required some treatment and were considered to be moderate complications. There were major complications—meaning life-threatening signs or symptoms, with some residual disability—for 7.4% of the kratom exposures. The adverse effects included: tachycardia [abnormally rapid heartbeat] in 25% of the reported cases, agitation or irritability in 23.8%, drowsiness in 19.4%, nausea in 14.7% and hypertension in 11.7%. There are also reports of liver damage and withdrawal. The science confirming adverse effects and supporting the scheduling of kratom as a controlled substance is not as weak as claimed. Allow research to be done that demonstrates and confirms its medical benefits and its adverse effects.

See also “The Secret of Kratom,” and “Noose Tightening on Kratom” on this website for more information on kratom and its regulation.

09/29/14

Psychoactive Science or Sideshow

© Randomshots | Dreamstime.com - Medicine Wagon Photo

© Randomshots | Dreamstime.com – Medicine Wagon Photo

There is a growing call to permit research into the therapeutic benefits of a variety of psychoactive drugs currently classified by the DEA as Schedule 1 controlled substances. The editors of Scientific American called for the U.S. government to move LSD, ecstasy, marijuana and others into Schedule 2, with cocaine, methamphetamine, fentanyl and Ritalin. They point out that such a move would not lead to decriminalization, “but it would make it much easier for clinical researchers to study their effects.”

Schedule 1 controlled substances are “drugs with no currently accepted medical use and a high potential for abuse.” They are seen as the most dangerous drugs, “with potentially severe psychological or physical dependence.” Schedule 2 controlled substances are “drugs with a high potential for abuse, less abuse potential than Schedule 1 drugs, with use potentially leading to severe psychological or physical dependence.”

British researchers have also called for greater access to “classical hallucinogens” such as psilocybin (magic mushrooms, another Schedule 1 drug) and LSD for research into treating depression.

Classical hallucinogens alter the functioning of this system [serotonergic], but not in the same way current medications do: whilst there are identified receptors and neurotransmitter pathways through which hallucinogens could therein produce therapeutic effects, the neurobiology of this remains speculative at this time.

These drugs are all caught in a catch-22, de facto ban on their use in medical research because of their Schedule 1 placement. “These drugs are banned because they have no accepted medical use, but researchers cannot explore their therapeutic potential because they are banned.” Three United Nations treaties extend similar prohibitions to rest of the globe, further complicating their reclassification as Schedule 2 drugs.

British psychiatrist David Nutt has argued that the U.N. charters are outdated and restrict doctors and scientists from studying hundreds of drugs.  He likened this “research censorship” to the Catholic Church banning Galileo from teaching or defending heliocentric ideas in the 1600s. Nutt suggested the Catholic Church banned the telescope, but the ban was actually on books that taught Copernican beliefs.

Nevertheless, he called the laws, which do not discriminate between research and recreational drug use relics of another age. “These laws serve no safety value. . . . The licenses and bureaucracy surrounding them can increase the costs of research tenfold, further limiting what is done.”  Dr. Nutt commented on how LSD and other hallucinogens like psilocybin had potential to explore and treat the brain. “Other therapeutic targets for psychedelics are cluster headaches, OCD and addiction.”

The argument for reclassifying psychoactive substances like marijuana, LSD, ecstasy and psilocybin from Schedule 1 to Schedule 2 has its pros and cons for me. The above discussion presents the case for reclassification, permitting future research into these substances. IF the ideal of rigorous, methodical research into the therapeutic potential of these drugs is followed, all is well.

But we are now in the midst of an epidemic of prescription drug abuse that came through the very same gauntlet of review and approval that these known recreational drugs would pass through to become medicinal agents once they were reclassified. And while there are potential therapeutic applications for marijuana, the current state of medical marijuana looks more like the older sideshow of patent medicines, where you could get cocaine toothache drops, heroin for cough relief, and Mrs. Winslow’s Soothing Syrup (which contained morphine) for teething discomfort.

UntitledIf special interest groups can be held off from bringing about a new age of snake oil salesmanship, then reclassifying these substances and permitting legitimate scientific research makes sense. Done correctly, it might even demonstrate that some of the existing curative claims for medical marijuana and other substances were false. But if these psychoactive substancess achieve FDA approval for any reason, they could be prescribed “off label” as is currently the case with other FDA approved drugs.