Natural Products Insider

MAY-JUN 2018

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4 INSIDER May/June 2018 In the News A group of researchers maintain a U.S. ban on kratom could exacerbate the nation's opioid crisis by depriving consumers of a potentially safe alternative to addictive and dangerous drugs, including opioids sold on the black market. At stake: the accessibility of kratom for millions of Americans—many of whom are reported to have used the botanical to wean off opioids, like heroin and oxycodone. "Instead of the inappropriate scheduling of kratom as though it were heroin or a similar narcotic, we're urging the promotion of good manufacturing practices [GMPs] complying to FDA standards, as is the case with other widely available supplements in the United States," said Marc Swogger, Ph.D., associate professor of psychiatry at the University of Rochester Medical Center, during a March 7 conference call with the media. Swogger said he and three other kratom researchers on the call urged "FDA to cease its scientifi cally unsupported statements about kratom because we believe that science matters." FDA has determined the compounds in kratom share structural similarities with controlled opioids such as morphine derivatives. Using a new computational model developed by FDA scientists, the agency determined two of the most prevalent compounds in kratom—including mitragynine, which researchers have described as kratom's primary active constituent—activate opioid receptors. Based on scientifi c literature, computational modeling and adverse effects linked to humans, FDA offi cials are now describing the compounds in kratom as opioids. That has led kratom advocates to fear FDA will recommend—and the Drug Enforcement Administration (DEA) will adopt—a policy to ban the botanical in the United States, classifying it as a schedule I drug under the Controlled Substances Act (CSA). "The existing science indicates that many millions of people in the U.S. who use kratom rely on it as a lifeline away from potentially deadly opioids," Swogger said. "People use kratom to ease opioid withdrawal and to manage acute and chronic pain. Scheduling kratom would remove a valuable pain treatment option for millions, leading to greater opioid use with the likely consequences of increasing dangerous opioid dependence and overdose deaths," he added. However, FDA is unaware of any evidence that indicates the effectiveness or safety of kratom for any medical use. Contending "kratom is benign because it's 'just a plant' is shortsighted and dangerous," said Scott Gottlieb, M.D., commissioner of FDA, in a Feb. 6 statement. Gottlieb pointed out heroin contains morphine, which originates from opium poppy plants. Gottlieb described kratom as "an opioid that's associated with novel risks because of the variability in how it's being formulated, sold and used recreationally, and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms." Researchers question FDA's conclusions. Oliver Grundmann, Ph.D., clinical associate professor at the University of Florida's College of Pharmacy, who joined the kratom press call, said there's a critical distinction between kratom binding to opioid receptors and what happens afterward. Opioids, like heroin and oxycodone, activate a signaling pathway (G protein) responsible for analgesic effects and a second signaling pathway (beta-arrestin) associated with respiratory depression, Grundmann said in a follow-up phone interview. He explained the signaling pathway responsible for respiratory depression, which increases the risk of asphyxiation from lack of breathing, is not activated by mitragynine. This is the same pathway associated with other adverse effects, including constipation and development of dependence on drugs like heroin. While Grundmann acknowledged a risk of encountering breathing diffi culties or suffering respiratory depression if kratom is taken at extremely high doses, he said such adverse effects would be unlikely if the botanical is administered orally. Jack Henningfi eld, Ph.D., is an adjunct professor of behavioral biology at Johns Hopkins University School of Medicine and vice president of research, health policy and abuse liability at Pinney Associates, a pharmaceutical and consumer health care consulting fi rm. He supported the American Kratom Association (AKA) in its efforts to persuade DEA to withdraw its 2016 notice of intent to temporarily schedule mitragynine and 7-hydroxymitragynine— another active constituent of kratom—into schedule I of the CSA. "My team and I did that because we felt DEA was wrong on the science," Henningfi eld explained during the press conference, "and it would create a public health problem with the ban because we knew at that point that kratom was being used by many people in place of opioids." Researchers in the United States are examining molecules in kratom that could eventually result in safe medicines, Henningfi eld divulged, though he warned the process to develop a new drug is a long and expensive one: taking about a decade, on average, and costing US$2.5 billion. Meanwhile, many kratom researchers support FDA oversight of the botanical as a supplement. Henningfi eld maintained FDA has the tools to effectively regulate it, including working with FDA manufacturers on permitted labeling claims. Paula Brown, Ph.D., is an adjunct professor of biology at the University of British Columbia and director of the British Columbia Institute of Technology's Health and Food Products Research Group. She said it's important kratom products meet specifi cations for purity and are neither adulterated with opioids nor contain concentrated amounts of alkaloids beyond what's typically found in the leaves of the botanical. "At this juncture, there is no high-quality evidence to indicate that kratom is a serious public health threat, and there's a lot of evidence to suggest that banning it would be," Swogger stated. Researchers Combat FDA's Stance on Kratom, Favor Its Regulation as Supplement by Josh Long

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