The Stakes Are High As DEA Reconsiders Waging War On The Herb Kratom

http://www.huffingtonpost.com/entry/kratom-dea_us_583d8a66e4b04b66c01bb424

The FDA works – makes decisions – from clinical trials which takes 10+ yrs.  Will the FDA not recommend rescheduling Kratom….BUT… say that it can no longer be classified as a supplement and in order to be sold, will have to go thru clinical trials. Basically, still making Kratom UNAVAILABLE for OTC sale as long as clinical trials moves forward at a “snail’s pace” and will be giving BIG PHARMAS their next “cash cow” ?

Seven weeks after the U.S. Drug Enforcement Administration officially withdrew its plan to ban kratom, the federal government is once again set to decide the fate of the herb and the people who rely on it for pain relief and other treatment.

The DEA had initially planned to use its emergency scheduling power to push through the ban without input from the public, despite concerns from lawmakers and scientists ― as well as kratom users ― that the move would do more harm than good. In October, however, the DEA opened a public comment period allowing individuals to weigh in on the agency’s decision to place mitragynine and 7-hydroxymitragynine, two active compounds in kratom, in Schedule I. Substances in this category include heroin and LSD and are considered to have no known medical benefit and a high potential for abuse.

With the comment period set to close on Thursday, the DEA will now have to take into account the nearly 9,000 submissions from people who wanted to voice their opinions about this proposed expansion of the war on drugs.

But kratom isn’t in the clear yet. The DEA is currently awaiting the results of a U.S. Food and Drug Administration analysis on the potential harms and health benefits of the herb, which will determine if kratom truly poses an “imminent hazard to the public safety,” as the agency initially claimed in August.

The DEA doesn’t know when it will get the results of the FDA’s review, Russell Baer, a spokesperson for the agency, told The Huffington Post.

“We’ve asked the FDA to expedite their analysis, but they’ve not given us any indication as to when that may be done, other than as soon as practical,” said Baer. “They’re involved in an exhaustive scientific review and evaluation, so these things do take time.”

Although Baer said he expects the DEA to wait for the FDA’s analysis before deciding on an appropriate schedule for kratom ― or whether it should be scheduled at all ― he noted that the agency could still proceed with emergency scheduling even in the absence of more concrete scientific evidence.

The DEA’s next steps will have huge implications for people like Joshua Levy. In the video above, Levy explains that he turned to kratom after struggling with dependence on the opioid painkillers he’d been prescribed following a hit-and-run accident. Like many kratom users, he says the herb gave him back the life that had been taken from him by addiction and other side-effects of narcotic painkillers.

“Since I started taking kratom, since I had gotten off of the pain pills, my life has basically opened up dramatically,” Levy told HuffPost. “I got a new job. I’m building a friendship up with my sister that I haven’t had in a long time. I’m not lazy anymore. I don’t want to isolate myself. I want to go out, I want to be out of the house.”

The kratom community is full of success stories like Levy’s. But together, they form only anecdotal evidence of the herb’s benefits, which is not enough to support a more official confirmation of its medicinal value.

Experts like Andrew Kruegel, an associate research scientist at Columbia University, hope the DEA will allow kratom to remain legal so they can keep working to unlock the herb’s potential.

Kruegel’s studies have shown that kratom can be used to alleviate mild pain, and that the plant’s negative side effects are relatively minor.

“As a scientist, I try to be as objective as possible and not overstate the promise of kratom,” said Kruegel. “We just don’t know that much about the plant yet.”

But Kruegel also has bigger hopes for kratom, which he believes can be used to aid in the development of safer alternatives to the prescription opioids that claimed more than 18,000 lives in the U.S. in 2014 due to overdose.

“Of course, if it’s in Schedule I, historically that greatly limits the ability to do research on it,” he said.

Filed under: General Problems