A global battle looms over kratom, a potential opioid alternative

Now, kratom advocates point out that Washington is in the WHO’s best interest – an effort to end the running of the federal regulatory process by taking the international path of ending what it could not achieve domestically.

The World Health Organization’s Committee on Drug Dependence will conduct a “pre-review” of kratom. The analysis could pave the way for the drug to come under more scrutiny by global health regulators, which could put it on the path to scheduling. As a controlled substance.

Its proponents say the US or WHO’s scheduling of the drug will create more obstacles to its study — similar to complaints from domestic cannabis researchers who for more than 50 years have been allowed to study “research-grade” marijuana grown by a single federally certified person. facility.

“Making this banned substance would actually encourage people to use more dangerous drugs,” said Albert Perez-Garcia-Romeo, a professor at Johns Hopkins University School of Medicine who studies kratom.

A spokesperson for the US Food and Drug Administration said the agency will seek public comment to inform the US position if the World Health Organization recommends international controls on kratom or another drug under study next week.

“It is therefore too early to speculate on what measures, if any, will be necessary before that time,” she said.

While the Food and Drug Administration and HHS delay urging the World Health Organization to schedule kratom, they Public Comment Notice They indicated that their view of the plants was still bleak.

“Kraft is an increasingly common narcotic of abuse and readily available in the United States recreational drug market,” the FDA said.

The Food and Drug Administration (FDA) has long criticized kratom, warning consumers to avoid it and has seized imported supplements containing the substance. The agency has flagged several kratom distributors for marketing it as a treatment for opioid addiction or pain, claims not supported by science.

Both the Obama and Trump administrations tried to ban kratom only to withdraw due to the drug’s broad support from his followers in the public and members of Congress, including the senator. Cory Booker (DN.J.) and former Republican Senator Oren Hatch of Utah.

Scott Gottlieb, who served as commissioner of the Food and Drug Administration during the Trump administration, emphasized that kratom is just as dangerous as opioids, Tweet in May He is “convinced it is fueling the opioid addiction crisis”.

Gottlieb’s claim I prompted a quick reprimand From Brett Giroir, former Assistant Secretary of Health and Acting Food and Drug Administration Commissioner during the Trump administration. Giroir rejected the FDA’s recommendation to classify kratom as a Schedule 1 controlled substance because of “embarrassingly poor evidence and data, and a failure to consider public health in general.” Giroir, in a 2018 memo, rescinded HHS’s recommendation to ban kratom and called for further study and public comment.

After spending “hundreds of hours” reviewing the data, Giroir told POLITICO on Friday, he decided that listing kratom as a Schedule I drug would hamper research and potentially direct users toward more deadly options like heroin and fentanyl.

Gottlieb did not respond to requests for comment.

Garcia-Romeo said kratom’s popularity grew during the 2000s along with the opioid crisis, leading the Drug Enforcement Administration to classify it as a “drug of concern.” The drug is illegal in Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin, while some states such as Arizona and Utah have passed laws to regulate it.

Two compounds in kratom interact with opiate receptors in the brain, which has raised concerns about whether people might become dependent on its use.

But scientists like Garcia Romeo say the effects of kratom are different from those of opioids, noting that the drug doesn’t slow breathing as much as conventional opioids do.

“It’s a double-edged sword that can be abused, but it also has medicinal potential,” he said.

a A survey conducted by Garcia-Romeu in 2017 Of the approximately 2,800 self-described kratom users in the United States who are typically middle-aged and white, they use the substance to treat symptoms of anxiety, depression, pain, and opioid withdrawal. And 41 percent reported that they used kratom to wean themselves off opioids, and more than a third of that group said they had stopped taking these medications for more than a year.

“When you see something like this, the signal is that, you may have an effective treatment here for opioid dependence,” Garcia-Romeo said.

Mac Haddow of the American Kratom Association says his group wants to see the material regulated as a food product so that the raw materials are tested for contaminants like salmonella and heavy metals. He said FDA regulation also requires good manufacturing processes and labeling requirements.

The U.S. Food and Drug Administration recently granted a Contract worth $2.3 million to Altasciences in Overland Park, Kansas, to study kratom doses to determine the potential for abuse. but under Terms of solicitationThe US Food and Drug Administration (FDA) reserves the right to all data and documents produced by the Contractor, which are subject to a confidentiality agreement.

That could allow the Food and Drug Administration to keep study results confidential, Hadow said.

“We believe science should dictate this policy,” he said.

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