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The Bonvie Blog: Kratom

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

By BILL BONVIE

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 that this man-made catastrophe has killed an estimated 20,000 Americans from overdoses in 2016 alone.

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 the U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb.

Kratom, Gottlieb notes, is a plant that grows 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.

kratom

This file is licensed under the Creative Commons Attribution 3.0 Unported license, courtesy of ThorPorre

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, he says, 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 (as well as a county in Florida). 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 (not that you heard much about that on the news).

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?

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, noncaloric 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, beside 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, PhD, at the University of Mississippi and Edward W. Boyer, MD 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 American Kratom Association, or AK, issued an eight-factor analysis by Dr. Jack Henningfield, Ph.D., vice president of Research, Health Policy, and Abuse Liability at Pinney Associates, 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 that 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 Dr. 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-then-vigilant FDA in the first place).

And while we might not have the evidence of a “trade complaint” in this case, we do have an interesting coincidence. A mere two weeks after Gottlieb’s official diatribe on the supposed “deadly risks” of kratom, the FDA announced its approval of Sublocade, the first once-monthly extended-release buprenorphine injection, described as “a medication-assisted treatment option for opioid use disorder,” but which, according to its label warning, “can be abused in a manner similar to other opioids” with “life?threatening respiratory depression and death” having occurred in association with buprenorphine.

The approval, was granted to Indivior, Inc., a Richmond., Va.-based pharmaceutical company that seems to specialize in drugs intended to fight opioid addiction, pledging to “medicalize addiction as a chronic, relapsing condition that should be treated similarly to other chronic diseases.” In another official agency bulletin, Dr. Gottlieb had this to say about the new injectable product:

“Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety. Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan.”

Gottlieb added that the FDA plans “to issue guidance to expedite the development of new addiction treatment options,” and would “continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction.”

Obviously, since kratom is not included in those therapies, its promotion is not in keeping with those FDA efforts.

There’s also the matter of Dr. Gottlieb’s extensive Linked-In resume, which includes present or past affiliations with a number of drug companies — including pharma giant GlaxoSmithKline, whose “product investment board” page lists him as still being a member. (In this regard, Dr. Michael Carome, the director of Public Citizen’s Health Research Group, has accused Gottlieb of going after the “low-hanging fruit,” while generally running the agency in “the financial interest of industry.”)

Whatever the reason Gottlieb has so cavalierly dismissed the testimony of numerous individuals who feel kratom has rescued them from the grip of opioid or heroin addiction, it could mean we well may be throwing away our most valuable tool for ending that ongoing national tragedy at a time when it’s most needed.

Resources

US Marshals seize dietary supplements containing kratom

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom

American Kratom Association: Major New Analysis Shows No Basis For DEA To Restrict Herb Kratom

Results of My Kratom Experiment — David DiSalvo

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

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