The Food and Drug Administration seems poised to outlaw kratom, an herbal supplement that many consider to be a safer and effective alternative to prescription opioids.
The Drug Enforcement Agency (DEA) has already attempted to have it placed on Schedule 1 of the Controlled Substances Act, despite minimal evidence of harm or addictive potential, and much anecdotal evidence of medical benefit. These actions seem premature at best.
Maybe these agencies are just embarrassed by past substances they approved that turned out to have problems, so they are trying to get out in front of kratom before it becomes a problem.
In the 1990s, the pharmaceutical companies misled them into enabling the opioid epidemic with new opioids such as OxyContin that they claimed were much less addictive than morphine or codeine.
Heroin was originally marketed as an over-the-counter, non-addictive morphine substitute. (Spoiler alert: It wasn’t.) The Pure Food and Drug Act, the precursor to the FDA, had no problem with heroin at first. It only became prescription-only after 1914 and banned outright after 1924.
Officially kratom is just a dietary supplement, so it is not regulated as a drug. It’s an herb, grown in southeast Asia, related to coffee, and often sold as a capsule or “tea” in vitamin and “head” shops. True, many users and some sellers claim it has medical benefits, which might put it under the FDA’s purview.
Now the FDA says kratom is an opioid, addictive, and dangerous and is “associated” with 44 deaths (it was found in the bodies of 44 dead people between 2011 and 2017), though there is no evidence that it actually caused or contributed to death in most or all of those cases.
Given the evidence, it seems to be just a scare tactic designed to convince people that kratom should be placed on the Controlled Substances Act in the dreaded Schedule 1 reserved for drugs that have:
- A high potential for abuse.
- No currently accepted medical use in treatment in the United States.
- A lack of accepted safety for use under medical supervision.
Marijuana or cannabis arguably is the most famous drug on that schedule, which also includes LSD and heroin. Many advocates claim that marijuana does have medical benefit. In a 2016 article for The Atlantic, writer Dan Baum said that one of former President Richard Nixon’s top advisers admitted marijuana only ended up on Schedule 1 for political reasons: the hippies protesting the Vietnam War liked marijuana; so he outlawed it.
Not included on the Schedule are the actual drugs contributing to the opioid epidemic, such as oxycodone and hydrocodone, which have resulted in many more deaths. One reason is that many pain sufferers do benefit from them and don’t become addicted.
The same could be said for marijuana and kratom.
Another reason may be that oxycodone and hydrocodone have pharmaceutical companies behind them with deep pockets who can pay for studies that— misleadingly or not—demonstrate these substances are safe. Marijuana and kratom do not.
While it is may be technically correct to say, as FDA Commissioner Scott Gottlieb did Feb. 8, that “there is no evidence to indicate that kratom is safe or effective for any medical use,” it is equally fair to say there is no evidence that kratom is unsafe or ineffective for any medical use. It would be more accurate to say there are no scientific studies empirically proving either side of the argument.
There is anecdotal evidence—more than 44 cases—that it has helped people cope with chronic pain, post-traumatic stress disorder, and opioid withdrawal with little or no incidence of addiction. (No one has ever been proved to have died of a marijuana overdose either, and deaths that are “associated” with its use always include other substances.)
(High Sobriety— a rehabilitation center in California—actually uses marijuana as a medication-assisted treatment, and Greener Pastures, a residential treatment home in Portland, Maine opening March 1, plans to use both marijuana and kratom. But these are outliers.)
The evidence against kratom is so poor that if these cases are the best the FDA could find, kratom seems safer than many legal prescription and over-the-counter medications, as well as tobacco and alcohol.
One death cited in the CDC report involved a suicide which the young man’s parents attributed to kratom use and another case where “a person … was exposed to paroxetine (an antidepressant) and lamotrigine (an anticonvulsant and mood stabilizer) in addition to kratom.” Seven other deaths were attributed to similar self-reporting.
Another case, mentioned in a FDA press release was heavily redacted, but a writer for Huffington Post discovered was actually a homicide by a gunshot to the chest. Neither the FDA or CDC are calling for bans on paroxetine, lamotrigine, or guns.
That doesn’t mean kratom won’t soon be illegal. The DEA tried in 2016 before caving to public and congressional pressure. The FDA has just declared that kratom should be considered an opioid— apparently, so it will be considered a fellow traveler in the opioid epidemic.
Attorney General Jeff Sessions has already revealed himself to be hostile towards marijuana legalization and chomping at the bit to enforce the federal prohibitions, never mind the will of the electorate or President Donald Trump’s pre-election statements. (In 2015 Trump told The Washington Post, “Marijuana is such a big thing. … I really think we should leave it to the states.”)
The question is whether kratom—and cannabis, for that matter—should be illegal; and whether federal law should be enforced when it conflicts with state law.
Kratom is legal in at least 30 states, as is marijuana. Kratom is even available in a vending machine in Tucson. If kratom and marijuana can assist in recovery from opioid addiction, we can ill afford to ban them in the middle of an epidemic that is getting worse.
It’s natural that law enforcement would want to enforce the law. That’s their job. If all laws were enforced, however, the courts and jails and prisons would be more swamped and overcrowded than they are already. In 1998, a Michigan man was arrested for swearing in public. Few would argue that everyone who swore in public should be arrested.
Most likely, many first responders only have professional exposure to drug use at crime scenes, frequently overdoses, sometimes deaths. That is just another type of anecdotal evidence. Kratom probably hasn’t been found there often, at least not when no other drugs were present. The same might be said of marijuana.
Law enforcement should be happy to see cannabis decriminalized. Kratom remains legal because that removes criminal gangs from the equation. In states with legal medical marijuana, crime goes down. So do opioid overdose deaths.
Decriminalization also would make it easier for the studies to be conducted proving whether or not cannabis and kratom are safe. As a Schedule 1 drug under the Controlled Substances Act, cannabis requires permission from three US government agencies to be studied, and that marijuana can only be obtained from one NIDA-controlled farm.
The FDA doesn’t test drugs itself; that’s not in its mandate. It only evaluates research provided to it, usually by pharmaceutical companies who pay a testing fee to have their new drugs evaluated and perhaps approved. (90 percent aren’t.) That may save the government testing costs, but it is not a way always guaranteed to get the best medicines approved, just the most-likely-to-be-profitable ones.
Kratom is not currently illegal, but “herbal supplements generally haven’t been subjected to the same scientific scrutiny and aren’t as strictly regulated as medications.” In other words, the FDA considers drugs to be unsafe until proven safe, and supplements to be safe until proven unsafe.
You can’t even be sure what you are getting. The American Cancer Society reports that “since … 1994, the FDA and some independent researchers have found problems with some dietary supplements,” including that sometimes they:
- Are tainted with germs, pesticides, or toxic heavy metals
- Don’t contain what’s listed on the label.
- Contain more or less than the amount of the herb listed on the label
- Have ingredients that aren’t listed on the label at all.
Nine of the deaths FDA reported occurred in Sweden in 2010 when a kratom-based product was adulterated with a synthetic opioid. No similar incident has been reported in the US.
So far, no independent or kratom industry-supplied research has passed FDA muster. Pharmaceutical makers also don’t want to help marijuana be approved, especially since they have their own cannabis-based medicines to hawk.
While kratom itself is not yet illegal, since November 2017 the FDA has authorized US Customs to “seize with intent to forfeit” imported kratom. Shortly thereafter, the Denver Environmental Health department began rounding up and destroying kratom products in 16 shops, including $4,000-worth at Myxed Up Creations. But that store fought the seizure and was able to transfer the kratom to its other Colorado outlets, where it was still legal.
Government enforcement shouldn’t be allowed to destroy a lawful product just because one day one city decides the product is illegal. Nor should the government outlaw it just because no pharmaceutical company has spent the necessary money on research. Unless that is just an excuse, it should do the research itself.
Kratom may not be perfectly safe, but to ban it now based on sketchy evidence of harm will only harm those now benefiting from it.
Stephen Bitsoli, a Michigan-based freelancer, writes about addiction, politics and related matters for several blogs. He welcomes readers’ comments.
original article: https://thecrimereport.org/2018/02/27/why-kratom-shouldnt-be-swept-up-in-the-opioid-crackdown/