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Title: The American Legion Wants Marijuana Reclassified to Help Treat PTSD
Source:
Reason
URL Source: https://reason.com/blog/2016/09/06/ ... an-legion-wants-marijuana-recl
Published: Sep 6, 2016
Author: Scott Shackford
Post Date: 2016-09-07 07:37:27 by Deckard
Keywords: None
Views: 19659
Comments: 72
These aren't your filthy hippies and stoners looking for an excuse to toke (not that there's anything wrong with that!): The American Legion is calling for the federal government to reclassify marijuana to acknowledge its potential benefits as a medical treatment. As Jacob Sullum previously noted, The Drug Enforcement Agency (DEA) is stubbornly refusing to change the federal classification of marijuana as a drug that has no "accepted medical use" until science proves them wrong. Fortunately they're easing off on the Catch-22 situation that has resulted in this classification making it extremely difficult for researchers to perform the very scientific testing that could determine marijuana's medical value. One of the potential medical values of medical marijuana is as a treatment for Post-Traumatic Stress Disorder (PTSD). And in what must certainly at this point make it abundantly clear where the majority of Americans stand on marijuana use, the American Legion has just voted at its national convention to support a resolution calling on Congress to legislatively reclassify cannabis and place it in a category that recognizes its potential value. The resolution, readable here at marijuana.com, highlights a number of important statistics that have helped push the Legion to support it. Across two years, the Department of Veterans Affairs have diagnosed thousands of Afghanistan and Iraq War veterans as having PTSD or Traumatic Brain Injuries (TBI). More than 1,300 veterans in fiscal year 2009 were hospitalized for brain injuries. And the resolution notes that systems in the brain can respond to 60 different chemicals found in cannabis. Therefore, the American Legion wants the DEA to license privately-funded medical marijuana and research facilities and to reclassify marijuana away from being lumped in with drugs like cocaine and meth. Tom Angell over at marijuana.com notes that Sue Sisley, a psychiatrist and medical marijuana researcher, has been lobbying the Legion and their local posts to get their support. Sisley is notable for actually getting federal permission to research marijuana as a treatment for PTSD and then getting dumped by the University of Arizona (where she worked) in 2014. What does this mean for a legislative effort to give VA docs permission to actually talk about medical marijuana as a treatment for veterans? As I noted in May, there was an amendment to a military appropriations bill that would end a gag order that prohibits VA doctors from recommending or even discussing medical marijuana treatment with patients, even in states where it had been legalized. The amendment would end the gag order, but wouldn't permit the VA to prescribe or pay for marijuana. The amendment passed the House and Senate, but as Angell notes, after the two sides went through the reconciliation to hammer out any difference, the language completely disappeared. It is no longer part of the Veterans Administration package. Legislators return to session today to hammer out last-minute spending bills to keep the government running (and the Democrats and Republicans are currently in disagreement on how long to extend spending authorizations for the incoming administration). Technically the amendment's language could be restored. 
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#1. To: Deckard (#0)
DEA, 81 FR 53779-53781, August 12, 2016 State-level public initiatives, including laws and referenda in support of the medical use of marijuana, have generated interest in the medical community and the need for high quality clinical investigation as well as comprehensive safety and effectiveness data. In order to address the need for high quality clinical investigations, the state of California established the Center for Medicinal Cannabis Research (CMCR, www.cmcr.ucsd.edu) in 2000 ''in response to scientific evidence for therapeutic possibilities of cannabis[9] and local legislative initiatives in favor of compassionate use'' (Grant, 2005). State legislation establishing the CMCR called for high quality medical research that would ''enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent,'' but stressed the project ''should not be construed as encouraging or sanctioning the social or recreational use of marijuana.'' The CMCR funded many of the published studies on marijuana's potential use for treating multiple sclerosis, neuropathic pain, appetite suppression and cachexia. However, aside from the data produced by CMCR, no state-level medical marijuana laws have produced scientific data on marijuana's safety and effectiveness. FDA approves medical use of a drug following a submission and review of an NDA or BLA. The FDA has not approved any drug product containing marijuana for marketing. Even so, results of small clinical exploratory studies have been published in the current medical literature. Many studies describe human research with marijuana in the United States under FDA-regulated IND applications. However, FDA approval of an NDA is not the only means through which a drug can have a currently accepted medical use in treatment in the United States. In general, a drug may have a ''currently accepted medical use'' in treatment in the United States if the drug meets a five-part test. Established case law (Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994)) upheld the Administrator of DEA's application of the five-part test to determine whether a drug has a ''currently accepted medical use.'' The following describes the five elements that characterize ''currently accepted medical use'' for a drug[10]: i. the drug's chemistry must be known and reproducible ii. there must be adequate safety studies iii. there must be adequate and well- controlled studies proving efficacy iv. the drug must be accepted by qualified experts v. the scientific evidence must be widely available Marijuana does not meet any of the five elements necessary for a drug to have a ''currently accepted medical use.'' Firstly, the chemistry of marijuana, as defined in the petition, is not reproducible in terms of creating a standardized dose. The petition defines marijuana as including all Cannabis cultivated strains. Different marijuana samples derived from various cultivated strains may have very different chemical constituents including delta9-THC and other cannabinoids (Appendino et al., 2011). As a consequence, marijuana products from different strains will have different safety, biological, pharmacological, and toxicological profiles. Thus, when considering all Cannabis strains together, because of the varying chemical constituents, reproducing consistent standardized doses is not possible. Additionally, smoking marijuana currently has not been shown to allow delivery of consistent and reproducible doses. However, if a specific Cannabis strain is grown and processed under strictly controlled conditions, the plant chemistry may be kept consistent enough to produce reproducible and standardized doses. As to the second and third criteria; there are neither adequate safety studies nor adequate and well-controlled studies proving marijuana's efficacy. To support the petitioners' assertion that marijuana has accepted medical use, the petitioners cite the American Medical Association's (AMA) 2009 report entitled ''Use of Cannabis for Medicinal Purposes.'' The petitioners claim the AMA report is evidence the AMA accepts marijuana's safety and efficacy. However, the 2009 AMA report clarifies that the report ''should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the same and current standards for a prescription drug product.[11]'' Currently, no published studies conducted with marijuana meet the criteria of an adequate and well-controlled efficacy study. The criteria for an adequate and well-controlled study for purposes of determining the safety and efficacy of a human drug are defined under the Code of Federal Regulations (CFR) in 21 CFR 314.126. In order to assess this element, FDA conducted a review of clinical studies published and available in the public domain before February, 2013. Studies were identified through a search of PubMed[12] for articles published from inception to February 2013, for randomized controlled trials using marijuana to assess marijuana's efficacy in any therapeutic indication. Additionally, the review included studies identified through a search of bibliographic references in relevant systematic reviews and identified studies presenting original research in any language. Selected studies needed to be placebo-controlled and double-blinded. Additionally, studies needed to encompass administered marijuana plant material. There was no requirement for any specific route of administration, nor any age limits on study subjects. Studies were excluded that used placebo marijuana supplemented by the addition of specific amounts of THC or other cannabinoids. Additionally, studies administering marijuana plant extracts were excluded. The PubMed search yielded a total of 566 abstracts of scientific articles. Of these abstracts, a full-text review was conducted with 85 papers to assess eligibility. Of the studies identified through the search of the references and the 566 abstracts from the PubMed search, only 11 studies met all the criteria for selection (Abrams et al., 2007; Corey-Bloom et al., 2012; Crawford and Merritt, 1979; Ellis et al., 2009; Haney et al., 2005; Haney et al., 2007; Merritt et al., 1980; Tashkin et al., 1974; Ware et al., 2010; Wilsey et al., 2008; Wilsey et al., 2013). These 11 studies were published between 1974 and 2013. Ten of these studies were conducted in the United States and one study was conducted in Canada. The identified studies examine the effects of smoked and vaporized marijuana for the indications of chronic neuropathic pain, spasticity related to Multiple Sclerosis (MS), appetite stimulation in human immunodeficiency virus (HIV) patients, glaucoma, and asthma. All studies used adult subjects. The 11 identified studies were individually evaluated to determine if they successfully meet accepted scientific standards. Specifically, they were evaluated on study design including subject selection criteria, sample size, blinding techniques, dosing paradigms, outcome measures, and the statistical analysis of the results. The analysis relied on published studies, thus information available about protocols, procedures, and results were limited to documents published and widely available in the public domain. The review found that all 11 studies that examined effects of inhaled marijuana do not currently prove efficacy of marijuana in any therapeutic indication based on a number of limitations in their study design; however, they may be considered proof of concept studies. Proof of concept studies provide preliminary evidence on a proposed hypothesis involving a drug's effect. For drugs under development, the effect often relates to a short-term clinical outcome being investigated. Proof of concept studies often serve as the link between preclinical studies and dose ranging clinical studies. Thus, proof of concept studies generally are not sufficient to prove efficacy of a drug because they provide only preliminary information about the effects of a drug. In addition to the lack of published adequate and well-controlled efficacy studies proving efficacy, the criteria for adequate safety studies has also not been met. Importantly, in its discussion of the five-part test used to determine whether a drug has a ''currently accepted medical use,'' DEA said, ''No drug can be considered safe in the abstract. Safety has meaning only when judged against the intended use of the drug, its known effectiveness, its known and potential risks, the severity of the illness to be treated, and the availability of alternative remedies'' (57 FR 10504). When determining whether a drug product is safe and effective for any indication, FDA performs an extensive risk-benefit analysis to determine whether the risks posed by the drug product's side effects are outweighed by the drug product's potential benefits for a particular indication. Thus, contrary to the petitioner's assertion that marijuana has accepted safety, in the absence of an accepted therapeutic indication which can be weighed against marijuana's risks, marijuana does not satisfy the element for having adequate safety studies such that experts may conclude that it is safe for treating a specific, recognized disorder. The fourth of the five elements for determining ''currently accepted medical use'' requires that the national community of experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, accepts the safety and effectiveness of the substance for use in treating a specific, recognized disorder. A material conflict of opinion among experts precludes a finding of consensus. Medical practitioners who are not experts in evaluating drugs are not qualified to determine whether a drug is generally recognized as safe and effective or meets NDA requirements (57 FR 10499-10505). There is no evidence that there is a consensus among qualified experts that marijuana is safe and effective for use in treating a specific, recognized disorder. As discussed above, there are not adequate scientific studies that show marijuana is safe and effective in treating a specific, recognized disorder. In addition, there is no evidence that a consensus of qualified experts have accepted the safety and effectiveness of marijuana for use in treating a specific, recognized disorder. Although medical practitioners are not qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, we also note that the AMA's report, entitled ''Use of Cannabis for Medicinal Purposes,'' does not accept that marijuana currently has accepted medical use. Furthermore, based on the above definition of a ''qualified expert'', who is an individual qualified by scientific training and experience to evaluate the safety and effectiveness of a drug, state-level medical marijuana laws do not provide evidence of a consensus among qualified experts that marijuana is safe and effective for use in treating a specific, recognized disorder. As to the fifth part of the test, which requires that information concerning the chemistry, pharmacology, toxicology, and effectiveness of marijuana to be reported in sufficient detail, the scientific evidence regarding all of these aspects is not available in sufficient detail to allow adequate scientific scrutiny. Specifically, the scientific evidence regarding marijuana's chemistry in terms of a specific Cannabis strain that could produce standardized and reproducible doses is not currently available. Alternately, a drug can be considered to have a ''currently accepted medical use with severe restrictions'' (21 U.S.C. 812(b)(2)(B)), as allowed under the stipulations for a Schedule II drug. Yet, as stated above, currently marijuana does not have any accepted medical use, even under conditions where its use is severely restricted. In conclusion, to date, research on marijuana's medical use has not progressed to the point where marijuana is considered to have a ''currently accepted medical use'' or a ''currently accepted medical use with severe restrictions.'' - - - - - - - - - - [9] In this quotation the term cannabis is interchangeable with marijuana. [10] 57 FR I 0499, 10504–06 (March 26, 1992). [11] In this quotation the term cannabis is used interchangeably for marijuana. [12] The following search strategy was used, ‘‘(cannabis OR marijuana) AND (therapeutic use OR therapy) AND (RCT OR randomized controlled trial OR ‘‘systematic review’’ OR clinical trial OR clinical trials) NOT (‘‘marijuana abuse’’[Mesh] OR addictive behavior OR substance related disorders).’’
Which part of "calling on Congress to legislatively reclassify cannabis" did you not understand, nolu spam?
#38. To: ConservingFreedom (#31)
Which part of "reclassify it in a category that, at a minimum will recognize cannabis as a drug with potential medical value," makes sense to you? I know this is really taxing for you, but it seems to be lacking any scientific evidence to justify anything. Moreover, you seem to fail to recognize wordsmithing signifying nothing. RESOLVED, By The American Legion in National Convention assembled in Cincinnati, Ohio, August 30, 31, September 1, 2016, that The American Legion urge the Drug Enforcement Agency to license privately-funded medical marijuana production operations in the United States to enable safe and efficient cannabis drug development research; and, be it finally, RESOLVED, That The American Legion urge Congress to amend legislation to remove Marijuana from schedule I and reclassify it in a category that, at a minimum will recognize cannabis as a drug with potential medical value. DEA, 81 FR 53779-53781, August 12, 2016 Firstly, the chemistry of marijuana, as defined in the petition, is not reproducible in terms of creating a standardized dose. The petition defines marijuana as including all Cannabis cultivated strains. Different marijuana samples derived from various cultivated strains may have very different chemical constituents including delta9-THC and other cannabinoids (Appendino et al., 2011). As a consequence, marijuana products from different strains will have different safety, biological, pharmacological, and toxicological profiles. Thus, when considering all Cannabis strains together, because of the varying chemical constituents, reproducing consistent standardized doses is not possible. Additionally, smoking marijuana currently has not been shown to allow delivery of consistent and reproducible doses. However, if a specific Cannabis strain is grown and processed under strictly controlled conditions, the plant chemistry may be kept consistent enough to produce reproducible and standardized doses. It cannot meet the first test to safely prescribe as medicine. Alternately, a drug can be considered to have a ''currently accepted medical use with severe restrictions'' (21 U.S.C. 812(b)(2)(B)), as allowed under the stipulations for a Schedule II drug. Yet, as stated above, currently marijuana does not have any accepted medical use, even under conditions where its use is severely restricted. In conclusion, to date, research on marijuana's medical use has not progressed to the point where marijuana is considered to have a ''currently accepted medical use'' or a ''currently accepted medical use with severe restrictions.'' Marjuana has been determined to not have a "currently accepted medical use," nor a "currently accepted medical use with severe restrictions.'' Officially, within the schedule system, what the hell does it mean to "reclassify it in a category that, at a minimum will recognize cannabis as a drug with potential medical value?" Nobody said it does not have potential medical value. It has no currently accepted medical use. A requirement for Schedule V is "The drug or other substance has a currently accepted medical use in treatment in the United States." Absent a finding of some "currently accepted medical use in treatment in the United States," marijuana (or any other substance) is not even assignable to Schedule V, the lowest schedule. There is no schedule category that recognizes a substance with potential medical value. Just about every substance may have potential medical value. That does not connote that it has any currently accepted medical use. - - - - - - - - - -
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''The substance's chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement.''
''There must be adequate pharmacological and toxicological studies, done by all methods reasonably applicable, on the basis of which it could fairly and responsibly be concluded, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that the substance is safe for treating a specific, recognized disorder.''
''There must be adequate, well- controlled, well-designed, well-conducted, and well-documented studies, including clinical investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, on the basis of which it could be fairly and responsibly concluded by such experts that the substance will have the intended effect in treating a specific, recognized disorder.''
''The drug has a New Drug Application (NDA) approved by the Food and Drug Administration, pursuant to the Food, Drug and Cosmetic Act, 21 U.S.C. 355. Or, a consensus of the national community of experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, accepts the safety and effectiveness of the substance for use in treating a specific, recognized disorder. A material conflict of opinion among experts precludes a finding of consensus.'' and
''In the absence of NDA approval, information concerning the chemistry, pharmacology, toxicology, and effectiveness of the substance must be reported, published, or otherwise widely available, in sufficient detail to permit experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, to fairly and responsibly conclude the substance is safe and effective for use in treating a specific, recognized disorder.''
#31. To: nolu chan (#1)
Replies to Comment # 31. Which part of "calling on Congress to legislatively reclassify cannabis" did you not understand, nolu spam?
WHEREAS, In April 2016, the Drug Enforcement Agency gave its approval to a study on the effect of medical marijuana on post-traumatic stress disorder, the first randomized, controlled research in the U.S for PTSD that will use the actual plant instead of oils or synthesized cannabis; now, therefore, be it
Marijuana does not meet any of the five elements necessary for a drug to have a ''currently accepted medical use.''
As to the fifth part of the test, which requires that information concerning the chemistry, pharmacology, toxicology, and effectiveness of marijuana to be reported in sufficient detail, the scientific evidence regarding all of these aspects is not available in sufficient detail to allow adequate scientific scrutiny. Specifically, the scientific evidence regarding marijuana's chemistry in terms of a specific Cannabis strain that could produce standardized and reproducible doses is not currently available.
End Trace Mode for Comment # 31.
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