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Title: 45 Congressmen Ask DEA Not to Ban Kratom Next Week
Source:
U.S. News & World Report
URL Source: http://www.usnews.com/news/articles ... ea-not-to-ban-kratom-next-week
Published: Sep 23, 2016
Author: Steven Nelson
Post Date: 2016-09-26 21:23:16 by Deckard
Keywords: None
Views: 5813
Comments: 22
Reps. Mark Pocan, D-Wis., left, and Matt Salmon, R-Ariz., recruited dozens of colleagues to demand that the DEA not follow through with an emergency ban on kratom, which is slated to become illegal on September 30. Getty Images/AP A large and bipartisan contingent in Congress is asking the Obama administration to delay the sudden ban poised to take effect next week on possessing kratom, a Southeast Asian tree leaf product that supporters describe as a near-miraculous treatment for pain, depression and addiction to opiates and legal narcotics. Reps. Mark Pocan, D-Wis., and Matt Salmon, R-Ariz., recruited 45 signers in the House of Representatives on Friday afternoon for two letters, which will be sent Monday to Chuck Rosenberg, acting administrator of the Drug Enforcement Administration, and Office of Management and Budget Director Shaun Donovan. “This significant regulatory action was done without any opportunity for public comment from researchers, consumers and other stakeholders,” the lawmakers say in the letter to Rosenberg. “This hasty decision could have serious effects on consumer access and choice of an internationally recognized herbal supplement.” The letter to Donovan asks him to overrule the DEA, which is invoking a rarely used emergency power with just 30 days notice, warning the action "will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions.” Susan Ash, founder of the American Kratom Association consumer group, which organized a Sept. 13 protest at the White House, says she remains hopeful that the ban won't go into effect for two compounds in kratom that would essentially ban the plant. “I feel a lot of hope because the amount of congresspeople who are paying attention to this issue and the media and the public are really weighing in our favor – it’s finally coming to light who the average kratom consumer is,” Ash says. Those users include recovering heroin, cocaine and alcohol addicts, fibromyalgia patients, and people with arthritis and cancer, according to a sampling of attendees at the White House protest. Some veterans with post-traumatic stress disorder and people with depression say it has helped them, too. AKA Executive Director Paul Pelosi Jr. says he believes the DEA has been surprised by a deluge of user pleas to keep kratom legal and that "I think everyone's looking for a way to save face – like, 'How can we come back from this?'" Pelosi has tried kratom but does not regularly use it. He says he believes that between 4 million and 5 million Americans may be using kratom – an estimate higher than the hundred thousand or so others offer, which he bases on his understanding of industry sales figures. "It’s pretty safe. It may be slightly addictive, but there’s no overdose or safety issue, so I think the DEA was unaware people use it in a kava shop, a cafe and that veterans use the leaf naturally," he says. "It’s not just a couple of teens trying to get high. There’s limited party use for this.” Indeed, preliminary scientific analysis shows that kratom, despite DEA concern about safety and anecdotal reports about dependence potential, could offer substantial harm reduction -- particularly as accidental overdoses of opioids including legal painkillers and illegal drugs like heroin killed more than 28,000 in 2014 alone. Andrew Kruegel, associate research scientist at Columbia University, says research has shown significant differences between the two about-to-be-banned compounds – mitragynine and 7-hydroxymitragynine – and traditionally abused drugs that act on opioid receptors in the brain. "Both mitragynine and 7-hydroxymitragynine are partial agonists of the mu opioid receptor, and that is the same target that heroin, morphine and fentanyl bind to," Kruegel says. "But the key thing from the science side is they activate this receptor in a different way. For one, they are partial agonists, which means they stimulate the receptor to a lower level … no matter how high you go with the dose." "In animal studies, both mitragynine and 7-hydroxymitragynine produce almost no respiratory depression," he adds. "Of course this hasn’t been rigorously studied in humans because there have been no clinical trials, but anecdotal evidence – which is quite substantial – suggests that people aren’t dying of respiratory depression." Kruegel says the reason for a lack of respiratory depression, a primary cause of death in heroin and other opioid overdoses, is that the compounds appear to be biased agonists that only trigger one opioid pathway – called the G protein pathway – and not another pathway associated with respiratory depression and constipation. Kruegel says mitragynine and 7-hydroxymitragynine preliminarily appear "similar in terms of pharmacology" to a drug called Oliceridine that currently is undergoing Food and Drug Administration-approved phase three trials in humans. Columbia University researchers currently are scrambling to complete research for a paper on kratom's effects on non-opioid receptors, and are busily boiling leaf matter in alcohol to extract the mitragynine and use chemical reactions to convert it into non-Schedule I analogs. "We obviously can't have kilograms of kratom around here when the ban goes into effect," Kruegel says. If the ban does go into effect, Kruegel says he would like to apply for a special Schedule I license to continue research, but he points out the hoops to jump through are onerous – as marijuana researchers have lamented for years – including installation of a safe that costs about $10,000. Despite the backlash, the DEA's knees aren't buckling, though sympathetic statements one spokesman offered the Washington Post last week gave some advocates hope. "I want the kratom community to know that the DEA does hear them," spokesman Melvin Patterson told the Post. "Our goal is to make sure this is available to all of them." With a week to go before the ban is scheduled to take effect, however, spokeswoman Barbara Carreno says she has received no indication there will be a reversal. "It's not that the DEA is unsympathetic to people who have chronic pain or who are addicted to opioids," she says. "We are people just like everyone else who get in a car accident and break our femurs and get cancer and have surgery and are in need of pain medicine. … It’s just that science says this is a problem and we need to keep people safe." Carreno says "the analysis we did showed there is enough of a public health problem with kratom" to justify it being placed in Schedule I on an emergency basis, a classification that would last two or three years until removal, permanent listing or scheduling in a lower ranking based on additional research. "I have not been advised it's being reconsidered, but we have not gotten the congressional letter," Carreno says. The DEA said in its notice last month that it believes 15 deaths in the U.S. were associated with kratom. The AKA disputes this and says it hired a toxicologist who reviewed the cases and found that there was no evidence to support the assertion and that most, if not all, of the deaths may have been tied to other drug use. In addition to the congressional letter, lawyers for the AKA are sending the DEA their own letter on Monday, Ash says, though there are no immediate plans for a lawsuit. The AKA has received an influx in donations, Ash says, and the Botanical Education Alliance industry group is also working to combat the ban. Pelosi, son of House Minority Leader Nancy Pelosi, D-Calif., says he's a volunteer with AKA and that he focuses on the community-organizing aspect of advocacy, rather than lobbying members of Congress. His mother was not among the letter's signers. If the ban does take effect, it's likely to wallop entrepreneurs who have invested hundreds of thousands – or millions – of dollars in the leaf matter, which generally is powderized for use in teas or pills. Nu Wave Botanicals national sales manager Chris Kratom (a professional rather than legal surname) says he is winding down operations with a business partner. The men operate a warehouse in Utah and two in Texas, he says, and are shipping everything to one of the Texas locations to be cataloged. Kratom, who primarily wholesales product sourced in Indonesia to other distributors, says he personally has more than $100,000 worth of product that he will be unable to sell. His partner has about $1 million worth of unsold kratom. That puts the entrepreneurs in a pickle. Two other businesses with similarly large stockpiles are taking the product to Mexico or Canada, where the plant remains legal, Kratom has heard. But Kratom, whose converts to the product include his Mormon father, currently is leaning toward turning over his supply to the DEA when the ban takes effect. He says he's in contact with the local DEA office and that it's his understanding his choices are to incinerate the supply or hand it over. "I have a family and I don't have an arrest record. ... I'm going to keep it that way," he says. "We want to work with the DEA so in case the hammer goes down on the 30th we have nothing to raid." Kratom says if he gives his product to the DEA he probably can write it off on his taxes and potentially get it back if the DEA decides to delay implementation of the ban. If he took it overseas, he says, he lacks the business connections to sell it and probably would have great difficulty repatriating it if the ban lapses. "Rumor has it," he say, "it doesn't look like they're actually going to do this on the 30th." Though the DEA says publicly it's standing firm, Ash warns the stakes are high. "A lot of people say they are scared to death of relapsing without [kratom]," she says. "And if this ban goes through there's going to be an illicit black market, and who knows what people are going to be putting into this product, so deaths are going to increase by that in itself." Read the letters: The list of lawmakers who signed, provided by Pocan spokesman David Kolovson: Mark Pocan, D-Wis. Steve Cohen, D-Tenn. Tulsi Gabbard, D-Hawaii Julia Brownley, D-Calif. Suzanne Bonamici, D-Ore.
Matt Salmon, R-Ariz.
John Conyers, D-Mich.
Hank Johnson, D-Ga.
Tim Ryan, D-Ohio
Jared Polis, D-Colo
Adam Smith, D-Wash.
Dana Rohrabacher, R-Calif.
Joe Heck, R-Nev.
John Yarmuth, D-Ky.
Dan Benishek, R-Mich.
Mark Sanford, R-S.C.
Mick Mulvaney, R-S.C.
Keith Ellison, D-Minn.
Steve Israel, D-N.Y.
Ted Poe, R-Texas
Gerald Connolly, D-Va.
Betty McCollum, D-Minn.
Earl Blumenauer, D-Ore.
Gwen Moore, D-Wis.
Brad Wenstrup, R-Ohio
Tom Graves, R-Ga.
Justin Amash, R-Mich.
Michael Honda, D-Calif.
Barbara Lee, D-Calif.
Raúl Labrador, R-Idaho
Peter DeFazio, D-Ore.
Scott Tipton, R-Colo.
Morgan Griffith, R-Va.
Jim Costa, D-Calif.
Suzan DelBene, D-Wash.
Denny Heck, D-Wash.
Zoe Lofgren, D-Calif.
Dave Brat, R-Va.
Scott Peters, D-Calif.
Tom Emmer, R-Minn.
Paul Gosar, R-Ariz.
Michael Capuano, D-Mass.
Leonard Lance, R-N.J.
Frank LoBiondo, R-N.J.
Bobby Scott, D-Va.
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#1. To: Deckard (#0)
Kratom is a relatively new drug to the US and Europe. It has been used for many years in Southeast Asia as an anti-diarrheal medicine, a painkiller and a recreational drug. Kratom is the popular name for a tree and the drug comes from its leaves. The drug may be bought in leaf form but in this country, it is more likely to be purchased as a capsule filled with powdered leaf material or a chopped up form of the leaf that can be used for tea or smoking. Most people ingest the drug. The effects of kratom come on rather quickly and last between five and seven hours, although high doses can last longer. Kratom is heavily promoted as a legal, undetectable, safe drug that can be used to come off stronger drugs. It is not yet illegal in the US but the breakdown products of kratom can be detected with some drug tests. Because of its legality, the drug tends to be more popular among young people who cannot yet buy alcohol and who may be concerned about being arrested with weed or other drugs. Kratom is included in a newly-defined class of drug called New Psychoactive Substances, so-named by the United Nations Office on Drugs and Crime. In the 2013 World Drug Report, kratom is on this list along with khat (another plant, this one from East Africa), Salvia divinorum (a plant that is widely available in the US), and synthetics ketamine, mephedrone and others. Many of these drugs are not yet illegal in the US and Europe, despite their dangerous and addictive effects. Even when a drug sends people to the emergency room and even when it is known to be addictive, it takes time to collect and compile all the scientific information that supports a legislative ban. Kratom has sent some people to emergency rooms and there have been calls to poison control centers in the US. Most of the adverse effects of this drug have been felt in Malaysia, Myanmar and Thailand where it is heavily used. The drug is illegal in Thailand. In Thailand in 2011, more than 13,000 people were arrested for kratom-related crimes (5% of all drug-related crimes in that country). The drug is abused for its sedative or stimulating effects. At low dosages, it is a stimulant, making a person more talkative, sociable and energetic. At higher dosages, it creates lethargy and euphoria. But the experience is not pleasant for every user. This drug only began to be seen in the US in 2012, but it is easy to obtain online. Many smoke shops, “head shops,” convenience stores and gas stations sell this drug. A person using this drug may not expect or want the following undesirable effects of kratom: Since the drug is also addictive, one of the effects can include compulsive use of the drug despite the harm that is being done to one’s mental state or life. Addiction effects may include: Withdrawal effects of kratom are very similar to those of opiates like heroin or prescription painkillers. They include: At this point in the US, the numbers are not large for people going to the emergency room with these adverse effects. But the drug is new to this country. If people are not educated about the adverse effects that can be suffered, including addiction, then the drug may become more popular and more damage may be seen. While every drug has different effects, the route back to sobriety is much the same from person to person. The recovery must include relief from incessant cravings near the beginning of rehab. Without this, a person undergoes a sort of daily or nightly torture, with continuous thoughts of using drugs or drug dreams at night. That’s why the Narconon drug and alcohol rehab program has a deep detoxification program very early in the recovery process. This phase of recovery, called the Narconon New Life Detoxification, enables each person to flush out the toxins from past drug abuse that remain locked in fatty tissues. Sauna time, nutritional supplements in an exact regimen and daily exercise combine to drive these residues out. Those completing this step talk about how much more energy they have and many say that their cravings are completely gone. Life skills training follows this step, because it is essential that a person have the tools to create a life he (or she) can enjoy. This protects him from wanting to escape life’s realities by abusing drugs. The goal of the program is a drug-free individual. Find out how someone you care about can recover from addiction at Narconon.
81 FR 81 FR 59929 At 59930:
That doesn’t matter to these dumb asshole Paultard dopers. They put drugs as their top priority in life, ahead of all responsibilities one should have as an adult.
Yes, scotch should be approved as medicine for pain relief and other palliative effects. Then I can get a prescription for it and let health insurance pay for refills. For medicinal purposes only.
Anything goes liberal assholes, like Decktard don't give a shit about personal responsibility or his peers suffering consequences for their poor choices.
Anything goes liberal assholes, like Decktard don't give a shit about personal responsibility or his peers suffering consequences for their poor choices. The headline … The headline is a misleading lie because 45 Congressmen never asked DEA “NOT” to ban kratom next week. I figured something was wrong since I know that Matt Salmon, a local Arizona Congressman, has stated opposition ot Prop 203, the ballot measure that would legalize the recreational use of marijuana in Arizona and I could not figure out why he would be “for” kratom. After checking, I find that Tristan Daedalus, the spokesman for Matt Salmon, said that Salmon is NOT suggesting that kratom go unregulated. Salmon is only asking “how the federal government reached its decision and should request comments from the scientific community and the general public.” The headline should have been: There is a HUGE difference in “asking not to ban” and “asking to delay listing.” But the pot smoke damaged brain of our the local drug whore has been too weakened to understand that.
No one is suggesting that in the first place. These 45 But you and the other neanderthals here just can't seem to grasp that simple fact.
But you and the other neanderthals here just can't seem to grasp that simple fact. 81 FR 81 FR 59929 At 59930: September 28, 2016 The Schedule I criteria uniquely states, "The drug or other substance has no currently accepted medical use in treatment in the United States." It is impossible to satisfactorily complete (the not yet started) obligatory studies before the scheduling date. As Kratom has no currently accepted medical use in treatment in the United States, Schedule I is the only applicable schedule. There is no need for an extended period for comments before scheduling. Irrelevant comments may be made on blogs. Of course, being on Schedule I, as is marijuana, does not prohibit approved research studies. It is unlikely that the FDA would approve everybody in California getting high just to see what happens, even if someone applies to try it as a research study. Gonzales v. Raich at 545 U.S. 1, 14:
Doctors to DEA: We'd like to study kratom to find out if it has any medical use. DEA to doctors: You can't do that because it's illegal and has no medical use. Doctors to DEA: How can you determine that it has no medical use without doing any actual studies. DEA to doctors: Because we say so.
DEA to doctors: You can't do that because it's illegal and has no medical use. Doctors to DEA: How can you determine that it has no medical use without doing any actual studies. DEA to doctors: Because we say so. DHHS makes the scientific and medical evaluations. If and when the effectiveness of kratom is established in well-controlled, well-designed, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients, they may give your insatiable desires high consideration. You are like a teen who does not take a road test but goes to the DMV for a drivers license and presents notes from various friends, neighbors, and mommy attesting to your being a safe driver. You do not get a license without a road test. DMV to Deckard: Because we say so. Americans for Safe Access et al v. DEA, 11-1265 (D.C. Cir. 22 Jan 2013) At 23: At 26-28: Contrary to what Petitioners suggest, something more than “peer-reviewed” studies is required to satisfy DEA’s standard, and for good reason. “[S]cientists understand that peer review per se provides only a minimal assurance of quality, and that the public conception of peer review as a stamp of authentication is far from the truth.” Charles Jennings, Quality and Value: The True Purpose of Peer Review, NATURE.COM (2006), http://www.nature.com/nature/ peerreview/debate/nature05032.html; see also Lynn S. McCarty et al., Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice, 120 ENVTL. HEALTH PERSP. 927, 930 (2012) (“It is difficult to extract from the extensive body of work and commentary published over the last 25-30 years that scientific journal peer review is a coherent, consistent, reliable, evaluative procedure. . . . [T]he opposite conclusion may be more accurate.”). Petitioners may have cited some peer–reviewed articles in support of their position, but they have not pointed to “adequate and well-controlled studies” confirming the efficacy of marijuana for medicinal uses. If, as is the case here, “there is substantial evidence to support the [agency’s] finding that the[] studies [offered by petitioner] are not helpful, then petitioner must fail.” Unimed, Inc. v. Richardson, 458 F.2d 787, 789 (D.C. Cir. 1972). In making this assessment, we must “remind ourselves that our role in the Congressional scheme is not to give an independent judgment of our own, but rather to determine whether the expert agency entrusted with regulatory responsibility has taken an irrational or arbitrary view of the evidence assembled before it.” Id. The DEA’s construction of its regulation is eminently reasonable. Therefore, we are obliged to defer to the agency’s interpretation of “adequate and well-controlled studies.” See Thomas Jefferson Univ., 512 U.S. at 512 (deferring to “an agency’s interpretation of its own regulations”). Judged against the DEA’s standard, we find nothing in the record that could move us to conclude that the agency failed to prove by substantial evidence that such studies confirming marijuana’s medical efficacy do not exist. Finally, Petitioners suggested during oral argument that the Government had foreclosed the research that would be necessary to create sufficiently reliable clinical studies of marijuana’s medical efficacy. Because Petitioners did not properly raise this issue with the DEA and there is nothing in the record to support it, we do not consider it here. We note, however, that DHHS’ recommendation explained that “[t]he opportunity for scientists to conduct clinical research with marijuana exists under the [D]HHS policy supporting clinical research with botanical marijuana.” Denial, 76 Fed. Reg. at 40,562. Thus, it appears that adequate and well-controlled studies are wanting not because they have been foreclosed but because they have not been completed.
Once again you ignorant fuckwad, this isn't about people "getting high" This is about DEA protecting Big Pharma.
This is about DEA protecting Big Pharma. DHHS makes the scientific and medical evaluations. If and when the effectiveness of kratom is established in well-controlled, well-designed, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients, they may give your insatiable desires high consideration. You are like a teen who does not take a road test but goes to the DMV for a drivers license and presents notes from various friends, neighbors, and mommy attesting to your being a safe driver. You do not get a license without a road test. DMV to Deckard: Because we say so. Americans for Safe Access et al v. DEA, 11-1265 (D.C. Cir. 22 Jan 2013) At 23: At 26-28: Contrary to what Petitioners suggest, something more than “peer-reviewed” studies is required to satisfy DEA’s standard, and for good reason. “[S]cientists understand that peer review per se provides only a minimal assurance of quality, and that the public conception of peer review as a stamp of authentication is far from the truth.” Charles Jennings, Quality and Value: The True Purpose of Peer Review, NATURE.COM (2006), http://www.nature.com/nature/ peerreview/debate/nature05032.html; see also Lynn S. McCarty et al., Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice, 120 ENVTL. HEALTH PERSP. 927, 930 (2012) (“It is difficult to extract from the extensive body of work and commentary published over the last 25-30 years that scientific journal peer review is a coherent, consistent, reliable, evaluative procedure. . . . [T]he opposite conclusion may be more accurate.”). Petitioners may have cited some peer–reviewed articles in support of their position, but they have not pointed to “adequate and well-controlled studies” confirming the efficacy of marijuana for medicinal uses. If, as is the case here, “there is substantial evidence to support the [agency’s] finding that the[] studies [offered by petitioner] are not helpful, then petitioner must fail.” Unimed, Inc. v. Richardson, 458 F.2d 787, 789 (D.C. Cir. 1972). In making this assessment, we must “remind ourselves that our role in the Congressional scheme is not to give an independent judgment of our own, but rather to determine whether the expert agency entrusted with regulatory responsibility has taken an irrational or arbitrary view of the evidence assembled before it.” Id. The DEA’s construction of its regulation is eminently reasonable. Therefore, we are obliged to defer to the agency’s interpretation of “adequate and well-controlled studies.” See Thomas Jefferson Univ., 512 U.S. at 512 (deferring to “an agency’s interpretation of its own regulations”). Judged against the DEA’s standard, we find nothing in the record that could move us to conclude that the agency failed to prove by substantial evidence that such studies confirming marijuana’s medical efficacy do not exist. Finally, Petitioners suggested during oral argument that the Government had foreclosed the research that would be necessary to create sufficiently reliable clinical studies of marijuana’s medical efficacy. Because Petitioners did not properly raise this issue with the DEA and there is nothing in the record to support it, we do not consider it here. We note, however, that DHHS’ recommendation explained that “[t]he opportunity for scientists to conduct clinical research with marijuana exists under the [D]HHS policy supporting clinical research with botanical marijuana.” Denial, 76 Fed. Reg. at 40,562. Thus, it appears that adequate and well-controlled studies are wanting not because they have been foreclosed but because they have not been completed.
#22. To: nolu chan (#21)
Once again you ignorant fuckwad, this isn't about people "getting high" What an insufferable little twat you are. Yeah - go ahead and post another 5Gb of spam - we're all so impressed. Statist whore.
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#2. To: Gatlin, Deckard (#1)
Kratom does not have an approved medical use in the United States and has not been studied as a treatment agent in the United States.
#3. To: nolu chan. Deckard (#2)
(Edited)
Kratom does not have an approved medical use in the United States and has not been studied as a treatment agent in the United States.
#7. To: Gatlin (#3)
They put drugs as their top priority in life, ahead of all responsibilities one should have as an adult.
#8. To: nolu chan, Gatlin (#7)
They put drugs as their top priority in life, ahead of all responsibilities one should have as an adult.
#10. To: GrandIsland, Nolu chan, misterwhite, Deckard (#8)
(Edited)
They put drugs as their top priority in life, ahead of all responsibilities one should have as an adult.
45 Congressmen Ask DEA Not to Ban Kratom Next Week
… is a LIE and just some more yellar journalism shit posted by the local drug whore and marijuana pimp. 45 Сongressmen Asks DEA to Delay Listing Kratom as Schedule I Drug
And then explained why, as I just did
#13. To: Gatlin (#10)
After checking, I find that Tristan Daedalus, the spokesman for Matt Salmon, said that Salmon is NOT suggesting that kratom go unregulated.
dopers congressmen are only trying to get the DEA to use some common frigging sense for once and take kratom off Schedule I to allow medical research.
#17. To: Deckard, Gatlin (#13)
These 45
dopers congressmen are only trying to get the DEA to use some common frigging sense for once and take kratom off Schedule I to allow medical research. Kratom does not have an approved medical use in the United States and has not been studied as a treatment agent in the United States.
In enacting the CSA, Congress classified marijuana as a Schedule I drug. 21 U. S. C. § 812(c). This preliminary classification was based, in part, on the recommendation of the Assistant Secretary of HEW “that marihuana be retained within schedule I at least until the completion of certain studies now underway.” Schedule I drugs are categorized as such because of their high potential for abuse, lack of any accepted medical use, and absence of any accepted safety for use in medically supervised treatment. § 812(b)(1). These three factors, in varying gradations, are also used to categorize drugs in the other four schedules. For example, Schedule II substances also have a high potential for abuse which may lead to severe psychological or physical dependence, but unlike Schedule I drugs, they have a currently accepted medical use. § 812(b)(2). By classifying marijuana as a Schedule I drug, as opposed to listing it on a lesser schedule, the manufacture, distribution, or possession of marijuana became a criminal offense, with the sole exception being use of the drug as part of a Food and Drug Administration preapproved research study. §§823(f), 841(a)(1), 844(a); see also United States v. Oakland Cannabis Buyers’ Cooperative, 532 U. S. 483, 490 (2001).
#18. To: nolu chan (#17)
(Edited)
Kratom does not have an approved medical use in the United States and has not been studied as a treatment agent in the United States.
#19. To: Deckard (#18)
Doctors to DEA: We'd like to study kratom to find out if it has any medical use.
In its scientific and medical evaluation, DHHS concluded that “research on the medical use of marijuana ha[d] not progressed to the point that marijuana [could] be considered to have a ‘currently accepted medical use’ or a ‘currently accepted medical use with severe restrictions.’” Id. at 40,560. As noted above, DHHS’ recommendations are binding on the DEA insofar as they rest on scientific and medical determinations. 21 U.S.C. § 811(b). After an exhaustive examination of the issue, the DEA, adhering to DHHS’ recommendation, reached the following conclusion:
To establish accepted medical use, the effectiveness of a drug must be established in well-controlled, well-designed, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients (57 FR 10499, 1992). To date, such studies have not been performed. The small clinical trial studies with limited patients and short duration are not sufficient to establish medical utility. Studies of longer duration are needed to fully characterize the drug’s efficacy and safety profile. Scientific reliability must be established in multiple clinical studies. Furthermore, anecdotal reports and isolated case reports are not adequate evidence to support an accepted medical use of marijuana (57 FR 10499, 1992). The evidence from clinical research and reviews of earlier clinical research does not meet this standard.
The DEA interprets “adequate and well-controlled studies” to mean studies similar to what the Food and Drug Administration (“FDA”) requires for a New Drug Application (“NDA”). See id. at 40,562. DHHS found that “there have been no NDA-quality studies that have scientifically assessed the efficacy of marijuana for any medical condition.” Id. It is well understood that, under FDA protocols, “adequate and well-controlled investigations” require “clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” 21 U.S.C. § 355(d). This is a rigorous standard. See, e.g., Edison Pharm. Co. v. FDA, 600 F.2d 831, 843 (D.C. Cir. 1979) (holding that substantial evidence supported the FDA’s conclusion that double-blind testing of a new drug was necessary before the drug could be administered to cardiac patients); Holland-Rantos Co. v. U.S. Dep’t of Health, Educ. and Welfare, 587 F.2d 1173, 1174 (D.C. Cir. 1978) (refusing to construe the requirement of a “well-controlled investigation” in a “self-defeating fashion”).
#20. To: nolu chan (#19)
they may give your insatiable desires high consideration.
#21. To: Deckard (#20)
Once again you ignorant fuckwad, this isn't about people "getting high"
In its scientific and medical evaluation, DHHS concluded that “research on the medical use of marijuana ha[d] not progressed to the point that marijuana [could] be considered to have a ‘currently accepted medical use’ or a ‘currently accepted medical use with severe restrictions.’” Id. at 40,560. As noted above, DHHS’ recommendations are binding on the DEA insofar as they rest on scientific and medical determinations. 21 U.S.C. § 811(b). After an exhaustive examination of the issue, the DEA, adhering to DHHS’ recommendation, reached the following conclusion:
To establish accepted medical use, the effectiveness of a drug must be established in well-controlled, well-designed, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients (57 FR 10499, 1992). To date, such studies have not been performed. The small clinical trial studies with limited patients and short duration are not sufficient to establish medical utility. Studies of longer duration are needed to fully characterize the drug’s efficacy and safety profile. Scientific reliability must be established in multiple clinical studies. Furthermore, anecdotal reports and isolated case reports are not adequate evidence to support an accepted medical use of marijuana (57 FR 10499, 1992). The evidence from clinical research and reviews of earlier clinical research does not meet this standard.
The DEA interprets “adequate and well-controlled studies” to mean studies similar to what the Food and Drug Administration (“FDA”) requires for a New Drug Application (“NDA”). See id. at 40,562. DHHS found that “there have been no NDA-quality studies that have scientifically assessed the efficacy of marijuana for any medical condition.” Id. It is well understood that, under FDA protocols, “adequate and well-controlled investigations” require “clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” 21 U.S.C. § 355(d). This is a rigorous standard. See, e.g., Edison Pharm. Co. v. FDA, 600 F.2d 831, 843 (D.C. Cir. 1979) (holding that substantial evidence supported the FDA’s conclusion that double-blind testing of a new drug was necessary before the drug could be administered to cardiac patients); Holland-Rantos Co. v. U.S. Dep’t of Health, Educ. and Welfare, 587 F.2d 1173, 1174 (D.C. Cir. 1978) (refusing to construe the requirement of a “well-controlled investigation” in a “self-defeating fashion”).
Replies to Comment # 21. they may give your insatiable desires high consideration.
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