Commentary

Is Kratom as Bad as the FDA Says or a Benign Alternative to Opioids? 

By BILL BONVIE | Nov 29, 2017

I have both some good news and some bad news to report.

The good news is that there may well be a relatively simple way for many individuals now caught up in the ongoing nationwide opioid crisis to pull themselves out of it. And that’s no small thing, considering that this man-made catastrophe killed an estimated 20,000 Americans from overdoses in 2016 alone. There were over 1,900 overdose deaths in New Jersey, a 10th of which were here in Ocean County.

The bad news is that the federal government is trying its best to make such apparent salvation illegal.

By that, I’m referring to a recent “public health advisory” about the “mounting concerns regarding risks associated with the use of kratom” issued by U.S. Food and Drug Administration Commissioner Scott Gottlieb.

Kratom, Gottlieb notes, is a plant growing naturally in Thailand, Malaysia, Indonesia and Papua New Guinea that has gained popularity in the U.S., with some marketers touting it as a “safe” treatment with broad healing properties, and which some people are using “to treat conditions like pain, anxiety and depression.” But what the FDA finds most concerning and “very troubling,” he says, is that “patients believe they can use kratom to treat opioid withdrawal symptoms” when “there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.”

No reliable evidence? That’s just the sort of assertion that infuriates a lot of former addicts who regard kratom as a godsend that has enabled them to successfully kick their habits and go back to leading normal lives. Like the wife and mother who, after being hooked on pharmaceuticals and street drugs for almost 20 years, told an interviewer she had been completely sober for 545 days and couldn’t say “that I would be where I’m at if it wasn’t for this plant.” Or the 24-year-old ex-heroin/prescription pill junkie who credits kratom with having kept him sober and responsible for three years, calling it a “safe alternative that is no more addictive than coffee or sugar.”

According to Gottlieb, however, “patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider” about its dangers and potential side effects, which include seizures, liver damage and withdrawal symptoms. In fact, the FDA announcement claims that three dozen deaths have been “associated with kratom-containing products.” And once having learned “a tragic lesson from the opioid crisis,” he believes the agency is now obliged to “use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold.”

And that’s just the latest step in a growing governmental effort to crack down on kratom, which last December was the subject of an FDA “import alert” and actual bans by several states. But there has also been considerable resistance. Last year, for example, approximately 142,000 people signed a White House petition to reverse a Drug Enforcement Administration proposal to ban two components of kratom by relegating them to the most restrictive classification of the U.S. Controlled Substances Act, which, along with a march in the nation’s capital and a bipartisan appeal from more than 50 members of Congress, helped bring about its withdrawal.

So who’s right – health authorities like Gottlieb who are making kratom out to be a new addiction menace or all those former addicts who are calling it a lifesaver and are supported by a lobbying group called the American Kratom Association?

My own opinion is that we really, really need to pay attention to what the latter folks are telling us. And that’s not just based on my reading about this subject so far, but on some extensive research my sister Linda and I did more than two decades ago for a magazine article and a short book we co-authored on another controversial plant – the sweet, non-caloric herb stevia.

The case against stevia being made by the FDA at that time, in fact, bears some remarkable similarities to what the agency is now saying about kratom. It also was considered to be an “adulterated” substance, one so dangerous as to necessitate the same sort of “import alert” as kratom and to prompt actual raids by armed federal marshals.

In the course of our research, two key officials at the FDA told me the reason for these actions was that not enough was known about stevia. That, however, was a rather spurious rationale since, besides its long history of use with no apparent adverse reactions, it had been extensively tested by Japanese researchers and was found to be completely safe.

The real reason for these Draconian actions, however, was that an unidentified company (apparently NutraSweet) had filed a “trade complaint” alleging that stevia was an “untested sweetener” that shouldn’t be allowed on the market. But a number of years later, after a major beverage manufacturer decided it wanted to use stevia in a soft-drink formula, stevia suddenly became A-OK for sweetening a variety of products.

So when I now hear the FDA raising similar concerns about kratom, another long-used plant whose benefits may be even more crucial, my hackles go up. Especially when one of the major concerns cited in the last “import alert” in December 2016 was that “there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”

Actually, there has been some very credible scientific examination into the benefits and possible risks of kratom undertaken in the past few years, particularly extensive research done by Christopher R. McCurdy at the University of Mississippi and Edward W. Boyer at the University of Massachusetts (whose work has yet to be peer-reviewed).

In one experiment, for instance, they administered repeated doses of morphine to mice with the purpose of getting them addicted, then abruptly halted the narcotic and fed them either regular food or food to which freeze-dried extracts of kratom tea had been added. They found that withdrawal symptoms had been almost completely blocked in the latter group.

And a year ago, the AKA issued an eight-factor analysis by Jack Henningfield, vice president of Research, Health Policy, and Abuse Liability at PinneyAssociates, a health consulting firm specializing in “issues associated with developing, registering and marketing medicines with abuse and diversion concerns.” Henningfield concluded that kratom’s potential for abuse and dependence was no greater than such widely used and unscheduled substances as “nutmeg, hops, St. John’s Wort, chamomile, guarana, and kola nut,” and that there was “insufficient evidence” for the DEA to ban or otherwise restrict its use.

OK, you might say, that’s the opinion of a paid consultant. But it’s remarkably similar to the results science and technology writer David DiSalvo got a few years ago in conducting his own “kratom experiment,” in which he himself was the guinea pig for several weeks. “My overall comment on kratom,” DiSalvo wrote, “is that it’s a lot like good coffee, but with a more even, long-lasting energy effect, and a much more pleasant ‘finish.’”

DiSalvo, in fact, maintained “without hyperbole that getting off coffee is a far worse experience than getting off kratom,” noting he was able to stop taking kratom for three days and at most  “experienced a bit of sluggishness that wore off in a day or so.” For him, at least, caffeine withdrawal was “significantly worse than kratom withdrawal, if it can even be called ‘withdrawal,’” adding that “there’s no comparison whatsoever.”

Based on his own experience, DiSalvo said he could “see no reason why it should be banned, or on what basis such a product would be banned.”

But if that’s the case, why, then is the FDA commissioner (in an administration that has such an ostensibly deregulatory mindset) so adamant about putting this supposedly therapeutic plant on a taboo list? As was the case with stevia, might there be an industry interest in keeping kratom off the market, at least for now?

A possible clue might be found in Gottlieb’s comment that “to date, no marketer has sought to properly develop a drug that includes kratom.” Of course they haven’t. Like stevia, kratom is a natural, nonproprietary substance that can’t be patented by the pharmaceutical industry, whose aim is always to develop the next “blockbuster” drug, and for whom risky pain relievers have become a huge source of income – hence, those opioids that they managed to get past a less-than-vigilant FDA in the first place.

And while we might not have the evidence of a “trade complaint” in this case, we do have Gottlieb’s extensive resume, which includes present or past affiliations with a number of  drug companies, including pharma giant GlaxoSmithKline.

Or perhaps any such insinuation that he has an ulterior motive is unfair to the new administrator, who could, after all, be perfectly sincere in his attempt to make sure that another opioid-like threat to the nation’s health doesn’t emerge on his watch.

Whatever the case, we could well be throwing away a valuable tool for ending that ongoing national tragedy of opioid addiction at a time when it’s most needed.

Bill Bonvie of Little Egg Harbor Township is a co-author of Badditives: The 13 Most Harmful Food Additives in Your Diet – and How to Avoid Them and author of the essay collection Repeat Offenders.

 

 

 

 

Comments (0)
If you wish to comment, please login.