DEA, 81 FR 53779-53781, August 12, 2016

Status of Research Into the Medical Uses for Marijuana

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

''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.''

ii. there must be adequate safety studies

''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.''

iii. there must be adequate and well- controlled studies proving efficacy

''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.''

iv. the drug must be accepted by qualified experts

''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

v. the scientific evidence must be widely available

''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.''

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).’’

Nothing the government has stated about pot is true which in my opinion makes people question what government says about other drugs. This leads to people trying and getting hooked on other more truly dangerous drugs like meth, crack, heron and more. Some of the most dangerous drugs are man-made drugs which leave people mentally broken for life such as K2/spice.

JFYI
I had smoked pot for nearly 5 years back in the 80's. Stopped without an issue and never had any side affects. It did not drive you crazy it just mellowed you out. It did not make me steal, rape or assault people.

Or is it nolu spam?

Either way your tedious copy and paste posts add nothing to the discussion.

Your submissive fealty to the State has been documented numerous times on this forum.

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.

Filthy hippies!

Nothing the government has stated about pot is true which in my opinion makes people question what government says about other drugs.

Nothing the government says about anything is true.

... your copy and paste posts add nothing to the discussion.

Coming for you....the king of copy and paste....that's hilarious !!!

ROTFL! BHAHAHAHAHAHAHAHAHAHAHAHAHAHA!

ROTFL! BHAHAHAHAHAHAHAHAHAHAHAHAHAHA!

Nothing the government says about anything is true.

Coming from a person who believes every yellow journalism article he reads.... that's hilarious !!!

ROTFL! BHAHAHAHAHAHAHAHAHAHAHAHAHAHA!

Marijuana can cause a psychotic episode.

As opposed to pharmaceutical anti-depressants which have been proven to cause psychotic episodes?

Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994)

Alliance for Cannabis Therapeutics, Petitioner, v. Drug Enforcement Administration, Respondent,physicians Association for Aids Care and the Lymphomafoundation of America, Intervenors.drug Policy Foundation and the National Organization for Thereform of Marijuana Laws, Petitioners, v. Drug Enforcement Administration, Respondent, 15 F.3d 1131 (D.C. Cir. 1994)

U.S. Court of Appeals for the District of Columbia Circuit - 15 F.3d 1131 (D.C. Cir. 1994)

Argued Oct. 1, 1993.

Decided Feb. 18, 1994

[304 U.S.App.D.C. 401] Petitions for Review of an Order of the Drug Enforcement Administration.

Steven K. Davidson, Washington, DC, argued the cause for petitioners. With him on the briefs were Amy W. Lustig, Washington, DC, and Kevin B. Zeese, Alexandria, VA. Thomas C. Collier, Jr., Washington, DC, entered an appearance for petitioner Alliance for Cannabis Therapeutics and intervenors in No. 92-1168.

Lena D. Mitchell, Attorney, U.S. Dept. of Justice, Washington, DC, argued the cause for respondent. With her on the brief was John C. Keeney, Acting Asst. Atty. Gen. Eumi L. Choi, Washington, DC, entered an appearance for respondent.

Steven K. Davidson and Amy W. Lustig, Washington, DC, were also on the brief for intervenors.

Before MIKVA, Chief Judge, and BUCKLEY and GINSBURG, Circuit Judges.

Opinion for the court filed by Circuit Judge BUCKLEY.

BUCKLEY, Circuit Judge:

The Alliance for Cannabis Therapeutics, the Drug Policy Foundation, and the National Organization for the Reform of Marijuana [304 U.S.App.D.C. 402] Laws petition for review of a final order of the Administrator of the Drug Enforcement Administration declining to reschedule marijuana from Schedule I to Schedule II of the Controlled Substances Act. Rescheduling to Schedule II would permit doctors to prescribe marijuana for therapeutic purposes. Petitioners' central claim is that the Administrator's order rests on an unreasonable interpretation of the statute. Because our previous disposition of this matter in Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991) ("ACT ") constitutes the law of the case, we decline to reconsider this claim. We also find that the Administrator satisfied ACT 's mandate on remand and that petitioners' other claims lack merit.

I. Background

A. Statutory Scheme

The Controlled Substances Act ("CSA") places hazardous drugs in five categories, or schedules, which impose varying restrictions on access to the drugs. See 21 U.S.C. § 812 (1988). Marijuana is assigned by statute to Schedule I, the most restrictive of these. See id. Schedule I drugs may be obtained and used lawfully only by doctors who submit a detailed research protocol for approval by the Food and Drug Administration and who agree to abide by strict recordkeeping and storage rules. See 21 C.F.R. Secs. 1301.33, 1301.42.

The CSA allows the Attorney General to reschedule a drug if he finds that it does not meet the criteria for the schedule to which it has been assigned. 21 U.S.C. § 811(a). The Attorney General has delegated this authority to the Administrator. See 28 C.F.R. Sec. 0.100(b). In rescheduling a drug, the Administrator must consider, inter alia, "[s]cientific evidence of [the drug's] pharmacological effect, if known," and "[t]he state of current scientific knowledge regarding the drug or other substance." 21 U.S.C. § 811(c) (2), (3).

A drug is placed in Schedule I if (1) it "has a high potential for abuse," (2) it has "no currently accepted medical use in treatment in the United States," and (3) " [t]here is a lack of accepted safety for use of the drug ... under medical supervision." 21 U.S.C. § 812(b) (1) (1988) (emphasis added). The Schedule II criteria are somewhat different: (1) the drug "has a high potential for abuse," (2) it "has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions," and (3) " [a]buse of the drug ... may lead to severe psychological or physical dependence." 21 U.S.C. § 812(b) (2) (1988) (emphasis added). Petitioners' central claim is that the Administrator misinterpreted the language italicized above.

B. Procedural History

This is the latest chapter in petitioners' efforts to move marijuana into a less restrictive CSA schedule. They claim that marijuana is misclassified because it has been shown to serve various medicinal purposes. Specifically, they contend that marijuana alleviates some side effects of chemotherapy in cancer patients, aids in the treatment of glaucoma, an eye disease, and reduces muscle spasticity in patients suffering from multiple sclerosis and other maladies of the central nervous system. In support of these contentions, they introduced affidavits and testimony of a number of patients and practicing physicians who insist that, in their experience, marijuana has proven safe and effective.

The petition to reschedule marijuana was first filed in 1972 and has been before this court on four prior occasions--National Org. for the Reform of Marijuana Laws v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974); National Org. for the Reform of Marijuana Laws v. Drug Enforcement Admin., 559 F.2d 735 (D.C. Cir. 1977); National Org. for the Reform of Marijuana Laws v. Drug Enforcement Admin. & Dep't of Health Education & Welfare, No. 79-1660 (D.C. Cir. Oct. 16, 1980); and most recently, ACT, 930 F.2d 936 (D.C. Cir. 1991). ACT is the only part of this history we need recount.

In ACT, the Alliance for Cannabis Therapeutics ("Alliance") and the National Organization for the Reform of Marijuana Laws ("NORML") argued that the Administrator's refusal to reschedule marijuana rested on an unreasonable interpretation of the statutory phrase, "currently accepted medical use." [304 U.S.App.D.C. 403] 930 F.2d at 939; see 21 U.S.C. §§ 812(b) (1) (B), (2) (B). In a scheduling proceeding involving another drug, the Administrator determined that " [t]he characteristics of a drug or other substance with an accepted medical use" include:

(1) scientifically determined and accepted knowledge of its chemistry;

(2) the toxicology and pharmacology of the substance in animals;

(3) establishment of its effectiveness in humans through scientifically designed clinical trials;

(4) general availability of the substance and information regarding the substance and its use;

(5) recognition of its clinical use in generally accepted pharmacopeia, medical references, journals or textbooks;

(6) specific indications for the treatment of recognized disorders;

(7) recognition of the use of the substance by organizations or associations of physicians; and

(8) recognition and use of the substance by a substantial segment of the medical practitioners in the United States.

53 Fed.Reg. 5,156, 5,157-58 (Feb. 22, 1988).

Applying these criteria to the petition to reschedule marijuana, the Administrator found on December 29, 1989, that marijuana had no currently accepted medical use and thus had to remain in Schedule I. 54 Fed.Reg. 53,767, 53,768 (1989). The eight-factor test had been published in the Federal Register on February 22, 1988, 17 days after the close of the evidence but before the oral arguments to the administrative law judge in the marijuana rescheduling proceedings.

On reviewing the Administrator's decision, we found the eight-factor test for determining whether a drug had a "currently accepted medical use" to be "in the main acceptable." ACT, 930 F.2d at 937. We noted the ambiguity of the phrase and the dearth of legislative history on point and deferred to the Administrator's interpretation as reasonable. Id. at 939 (citing Chevron U.S.A. Inc. v. Natural Resources Defense Council, 467 U.S. 837, 843-45, 104 S. Ct. 2778, 2782-83, 81 L. Ed. 2d 694 (1984) (court may not substitute its own construction of ambiguous statutory provision for reasonable interpretation by agency of statute entrusted to its administration)). We were troubled, however, by three of the eight criteria and remanded the case "for an explanation as to how [these] had been utilized by the Administrator in reaching his decision." Id. at 940. In particular, we were concerned over the apparent impossibility of meeting the fourth, fifth, and eighth criteria, all of which assumed an availability of marijuana for medical purposes that was prohibited by Schedule I.

On March 26, 1992, the current Administrator issued the order that is the subject of this appeal. See 57 Fed.Reg. 10,499 (Mar. 26, 1992) ("Final Order"). He concluded, on remand, that his predecessor had not in fact relied on two of the three "impossible" criteria; he explained the third; and, after applying new criteria, he again denied the petition to reschedule marijuana. Id. at 10,508.

II. Discussion

A. Law of the Case

[1] We held, in ACT, that the Administrator's interpretation of the CSA was reasonable. Under the "law of the case" doctrine, appellate courts do not reconsider matters resolved on a prior appeal in the same proceeding. 18 Wright & Miller, Federal Practice & Procedure Sec. 4478 at 788 (1981). The doctrine is not a jurisdictional limitation; rather, it "merely expresses the practice of courts generally to refuse to reopen what has been decided...." Messenger v. Anderson, 225 U.S. 436, 444, 32 S. Ct. 739, 740, 56 L. Ed. 1152 (1912). Thus, courts will reconsider previously decided questions in such exceptional cases as those in which there has been an intervening change of controlling law, or new evidence has surfaced, or the previous disposition has resulted in clear error or manifest injustice. 18 Wright & Miller, Sec. 4478 at 790.

[2] Petitioners do not contend that any of these exceptions apply here. Instead, they assert that in ACT we gave only cursory attention to the statutory interpretation argument whereas, in their view, the law of the [304 U.S.App.D.C. 404] case doctrine applies only where the prior appeal has analyzed an issue at length. We disagree on both counts. First, our treatment of the statutory interpretation question was entirely adequate. Second, even summarily treated issues become the law of the case. In Christianson v. Colt Industries Operating Corp., 486 U.S. 800, 817, 108 S. Ct. 2166, 2178, 100 L. Ed. 2d 811 (1988), the Supreme Court noted: "That the Federal Circuit did not explicate its rationale is irrelevant, for the law of the case turns on whether a court previously 'decide [d] upon a rule of law'--which the Federal Circuit necessarily did--not on whether, or how well, it explained the decision." In ACT, we decided that it was not "an unreasonable application of the statutory phrase [for the Administrator] to emphasize the lack of exact scientific knowledge as to the chemical effects of the drug's elements." 930 F.2d at 939.

As noted above, our only concern, in ACT, was with three of the standards adopted by the Administrator and his possible reliance on them. As a consequence, in remanding the case, we asked him to explain how his decision had been affected by those standards. In the Final Order, the present Administrator found that two of these criteria--the "general availability of the substance" and the "use of the substance by a substantial segment of ... medical practitioners"--played no role in his predecessor's decision. See 57 Fed.Reg. at 10,507.

[3] Further, the Administrator found that his predecessor's conclusion that marijuana failed to meet the third of the questioned criteria--"recognition of [the drug's] clinical use in generally accepted pharmacopeia"--rested on a determination that marijuana lacked a known, reproducible chemistry. See id. We had objected to the "recognition of clinical use" standard only because it seemed to require widespread therapeutic use of the drug--an impossibility for Schedule I substances. See ACT, 930 F.2d at 940. The Administrator's interpretation of that criterion meets our objection.

The Final Order discards the earlier formulation and applies a new five-part test for determining whether a drug is in "currently accepted medical use":

(1) The drug's chemistry must be known and reproducible;

(2) there must be adequate safety studies;

(3) there must be adequate and well-controlled studies proving efficacy;

(4) the drug must be accepted by qualified experts; and

(5) the scientific evidence must be widely available.

57 Fed.Reg. at 10,506. None of these criteria is impossible for a Schedule I drug to meet; in fact, petitioners concede in their briefs that the new standard has corrected the flaws we identified in ACT.

B. Petitioners Other Arguments

Petitioners make two additional arguments: (1) They assert that they were deprived of the opportunity to conform their evidentiary submissions to the governing legal standard because the previous Administrator had failed to publish the eight-factor test on which he relied, as required by the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552(a) (1) (D), until two weeks after the close of the evidence in the rescheduling proceeding; and (2) they claim that the Administrator's ruling was not the product of reasoned decisionmaking because he was biased and ignored the record.

While Alliance and NORML had apparently raised these issues in ACT, we did not expressly address them; nor did we decide them by necessary implication because our limited remand in ACT could have reflected a decision to postpone consideration of these remaining arguments. Accordingly, we conclude that ACT did not establish the law of the case as to these issues. See Bouchet v. Nat'l Urban League, 730 F.2d 799, 806 (D.C. Cir. 1984) (" [O]nly when an issue not expressly addressed must have been decided by 'necessary implication' will the [law of the case] doctrine be applied....").

1. The FOIA Claim

[4] Section 552(a) (1) of FOIA provides in relevant part:

[304 U.S.App.D.C. 405]

Each agency shall separately state and currently publish in the Federal Register for the guidance of the public--

. . . . .

(D) ... statements of general policy or interpretations of general applicability formulated and adopted by the agency....

. . . . .

Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner ... be adversely affected by [ ] a matter required to be published in the Federal Register and not so published.

5 U.S.C. § 552(a) (1) (emphasis added). This provision requires agencies to set out in advance the legal standards that will be applied so that "actions can be guided, and strategies planned." Northern Calif. Pwr. Agency v. Morton, 396 F. Supp. 1187, 1191 (D.D.C.), aff'd mem. sub. nom. Northern Calif. Pwr. Agency v. Kleppe, 539 F.2d 243 (D.C. Cir. 1976). To establish a claim under the statute, however, the litigant must show that "he was adversely affected by a lack of publication or that he would have been able to pursue an alternative course of conduct" had the information been published. Zaharakis v. Heckler, 744 F.2d 711, 714 (9th Cir. 1984).

[5] Petitioners argue that the Administrator violated the statute by using the eight-factor test to evaluate the evidence presented in the marijuana rescheduling petition. As the test was not published until 17 days after the close of the evidence, they contend that they were "adversely affected" by the Administrator's reliance on the test because they had no opportunity to tailor their evidence to meet its requirements. Accordingly, they ask us to remand the case to the Administrator with instructions to reopen the record for the submission of new evidence.

We decline to do so because petitioners have failed to demonstrate that they have in fact been adversely affected by the lack of notice. During the nearly two years between the publication of the eight-factor test on February 22, 1988, and the Administrator's ruling on December 29, 1989, petitioners never sought to reopen the record. As parties to an important controversy, they had a responsibility to proffer any evidence that was made newly relevant by the adoption of the criteria. Their failure to do so suggests either that they were satisfied that the evidence already presented would meet the test or that they had no further evidence to offer. Thus, we have no reason to believe that petitioners would have pursued an "alternative course of conduct" had the test been published earlier. Zaharakis, 744 F.2d at 714.

Furthermore, we do not agree that McLouth Steel Products v. Thomas, 838 F.2d 1317 (D.C. Cir. 1988), supports their position. That case is distinguishable. McLouth arose in the context of a rulemaking in which an agency failed to identify adequately a key standard in its notice of proposed rulemaking in violation of 5 U.S.C. § 553. Unlike petitioners, the McLouth challengers knew the governing legal standard by the time they were called on to submit evidence; their complaint was that they had not had a chance to challenge the standard at the time it was adopted. 838 F.2d at 1322-23. We held that the challengers were not required to demonstrate that the failure of notice had caused "specific prejudice" because "we cannot say with certainty whether petitioners' comments would have had some effect [on the adoption of the standard] if they had been considered when the issue was open." Id. at 1323-24. Here, petitioners' challenge is not to the standard but to their claimed inability to respond to it.

2. The Reasoned Decisionmaking Claim

In ACT, Alliance and NORML argued that the prior Administrator had been biased and ignored the record. On this appeal, petitioners repeat these claims and accuse his successor of the same errors. We need not consider whether the previous Administrator's ruling stemmed from reasoned decisionmaking, however, because we remanded it to the agency. We thus confine our review to the current Administrator's treatment of the record in the Final Order.

[6] In support of their bias claim, petitioners point to what they describe as a long history of the Drug Enforcement Administration's [304 U.S.App.D.C. 406] anti-marijuana prejudice as evidenced by this court's need to remand their petition on four occasions and what they describe as the prior Administrator's "unusually strident decision" rejecting the administrative law judge's recommendation that the drug be rescheduled. They also cite various statements by the present Administrator in the Final Order as evidence of a lack of objectivity. See, e.g., 57 Fed.Reg. at 10,502 ("The only favorable evidence that could be found by [petitioners] consists of stories by marijuana users"); id. (" [s]ick people are not objective scientific observers, especially when it comes to their own health."); id. at 10,503 ("Sick men, women and children can be fooled by these claims and experiment with the drug.... It is a cruel hoax to offer false hope to desperately ill people.").

[7] We are not impressed. The need to remand a case several times is not evidence per se of agency prejudice. Nor do we think the statements cited by petitioners show that the Administrator was unfair, especially when considered in the context of a reasonable preference for rigorous scientific proof over anecdotal evidence, even when reported by respected physicians.

[8] Moreover, our review of the record convinces us that the Administrator's findings are supported by substantial evidence. See 21 U.S.C. § 877 (1988) (substantial evidence standard applies to findings of fact in rescheduling proceedings). The Final Order canvasses the record at length. It recites the testimony of numerous experts that marijuana's medicinal value has never been proven in sound scientific studies. The Administrator reasonably accorded more weight to the opinions of these experts than to the anecdotal testimony of laymen and doctors on which petitioners relied. The Administrator noted that

[w]ith one exception, none of [these doctors] could identify under oath the scientific studies they swore they relied on. Only one had enough knowledge to discuss the scientific technicalities involved. Eventually, each one admitted he was basing his opinion on anecdotal evidence, on stories he heard from patients, and on his impressions about the drug.

Final Order, 57 Fed.Reg. at 10,502-03. These findings are consistent with the view that only rigorous scientific proof can satisfy the CSA's "currently accepted medical use" requirement. Id. at 10,500.

For the foregoing reasons, the petitions for review are

Denied.

Americans for Safe Access, et al., v. Drug Enforcement Administration, No. 11-1265 (D.C. Cir. 22 January 2013) slip op

[21]

B. The DEA’s Denial of the Petition to Initiate Proceedings to Reschedule Marijuana

On the merits, Petitioners claim that the DEA’s final order denying their request to initiate proceedings to reschedule marijuana was arbitrary and capricious. Under the terms of the CSA, marijuana cannot be rescheduled to Schedules III, IV, or V without a “currently accepted medical use.” 21 U.S.C. § 812(b)(3)-(5). To assess whether marijuana has such a medical use, the agency applies a five-part test: “(1) The drug’s chemistry must be known and reproducible; (2) There must be adequate safety studies; (3) There must be adequate and well-controlled studies proving efficacy; (4) The

[22]

drug must be accepted by qualified experts; and (5) The scientific evidence must be widely available.” See Denial, 76 Fed. Reg. 40,552, 40,579. The DEA’s five-part test was expressly approved by this court in Alliance for Cannabis Therapeutics, 15 F.3d at 1135. Because the agency’s factual findings in this case are supported by substantial evidence and because those factual findings reasonably support the agency’s final decision not to reschedule marijuana, we must uphold the agency action.

Under the Administrative Procedure Act, a court may set aside an agency’s final decision only if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). “We will not disturb the decision of an agency that has ‘examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made.’” MD Pharm. Inc. v. DEA, 133 F.3d 8, 16 (D.C. Cir. 1998) (quoting Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). Furthermore, the agency’s interpretation of its own regulations “must be given controlling weight unless it is plainly erroneous or inconsistent with the regulation.” Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994). The CSA also directs this court to review the agency’s findings of fact for substantial evidence. See 21 U.S.C. § 877. Under this standard, we must “ask whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.” Dickinson v. Zurko, 527 U.S. 150, 162 (1999). Petitioners do not seriously dispute the propriety of the five-part test approved in Alliance for Cannabis Therapeutics. Thus, they are left with the difficult task of showing that the DEA has misapplied its own regulations. Petitioners challenge the agency’s reasoning on each of the five factors. However,

[23]

“[a] drug will be deemed to have a currently accepted medical use for CSA purposes only if all five of the foregoing elements are demonstrated.” Denial, 76 Fed. Reg. at 40,579. In this case, we need only look at one factor, the existence of “adequate and well-controlled studies proving efficacy,” to resolve Petitioners’ claim.

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).

"As opposed to pharmaceutical anti-depressants which have been proven to cause psychotic episodes?"

Nope. Just like pharmaceutical anti-depressants which have been proven to cause psychotic episodes.

Just like pharmaceutical anti-depressants which have been proven to cause psychotic episodes.

Oh for fuck's sake - seriously?

How many mass shootings have been instigated by someone high on marijuana?

Marijuana can cause a psychotic episode. Is that something we want to give people with a psychiatric disorder?

In what medical dosage? Two tokes every four hours as necessary? Of a substance of unknown strength? This is why Deckard refuses to discuss the legal requirements for any substance to be accepted as medicine.

"How many mass shootings have been instigated by someone high on marijuana?"

We weren't discussing mass shootings or getting high. The discussion was about giving a substance known to cause psychosis to an individual who has been diagnosed as having a mental disorder.

I'm saying that I don't think it's a good idea.

"In what medical dosage? Two tokes every four hours as necessary?"

I believe the "doctor's" recommendation for marijuana would read more like, "Smoke as much as you want, as many times as you want, for as long as you want."

It's technical, I know.

"This is why Deckard refuses to discuss the legal requirements for any substance to be accepted as medicine".

Deckard want to make an exception for marijuana because shut up.

The DEA has an abnormal desire to stop pot use IMHO.

Your opinion is interesting. It has even been tried in court. It failed. It is not medicine. It is a Scheduled drug per international treaty and Federal law. The medical opinion of the DHHS is binding on the DEA.

See #10 and #11.

Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994)

[6] In support of their bias claim, petitioners point to what they describe as a long history of the Drug Enforcement Administration's [304 U.S.App.D.C. 406] anti-marijuana prejudice as evidenced by this court's need to remand their petition on four occasions and what they describe as the prior Administrator's "unusually strident decision" rejecting the administrative law judge's recommendation that the drug be rescheduled. They also cite various statements by the present Administrator in the Final Order as evidence of a lack of objectivity. See, e.g., 57 Fed.Reg. at 10,502 ("The only favorable evidence that could be found by [petitioners] consists of stories by marijuana users"); id. (" [s]ick people are not objective scientific observers, especially when it comes to their own health."); id. at 10,503 ("Sick men, women and children can be fooled by these claims and experiment with the drug.... It is a cruel hoax to offer false hope to desperately ill people.").

[7] We are not impressed. The need to remand a case several times is not evidence per se of agency prejudice. Nor do we think the statements cited by petitioners show that the Administrator was unfair, especially when considered in the context of a reasonable preference for rigorous scientific proof over anecdotal evidence, even when reported by respected physicians.

[8] Moreover, our review of the record convinces us that the Administrator's findings are supported by substantial evidence. See 21 U.S.C. § 877 (1988) (substantial evidence standard applies to findings of fact in rescheduling proceedings). The Final Order canvasses the record at length. It recites the testimony of numerous experts that marijuana's medicinal value has never been proven in sound scientific studies. The Administrator reasonably accorded more weight to the opinions of these experts than to the anecdotal testimony of laymen and doctors on which petitioners relied. The Administrator noted that

[w]ith one exception, none of [these doctors] could identify under oath the scientific studies they swore they relied on. Only one had enough knowledge to discuss the scientific technicalities involved. Eventually, each one admitted he was basing his opinion on anecdotal evidence, on stories he heard from patients, and on his impressions about the drug.

Final Order, 57 Fed.Reg. at 10,502-03. These findings are consistent with the view that only rigorous scientific proof can satisfy the CSA's "currently accepted medical use" requirement. Id. at 10,500.

Americans for Safe Access, et al., v. Drug Enforcement Administration, No. 11-1265 (D.C. Cir. 22 January 2013) slip op

Petitioners do not seriously dispute the propriety of the five-part test approved in Alliance for Cannabis Therapeutics. Thus, they are left with the difficult task of showing that the DEA has misapplied its own regulations. Petitioners challenge the agency’s reasoning on each of the five factors. However,

[23]

“[a] drug will be deemed to have a currently accepted medical use for CSA purposes only if all five of the foregoing elements are demonstrated.” Denial, 76 Fed. Reg. at 40,579. In this case, we need only look at one factor, the existence of “adequate and well-controlled studies proving efficacy,” to resolve Petitioners’ claim.

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).

It is not medicine.

So sayeth the almighty DEA.

How many doctors did the DEA consult with?

In what medical dosage? Two tokes every four hours as necessary?

Whatever works best for the individual.

I realize that this is an alien concept for you two fed.gov shills, but the government does NOT own your body.

I believe the "doctor's" recommendation for marijuana would read more like, "Smoke as much as you want, as many times as you want, for as long as you want."

Yep. Any kind of doctor. It could be Deckard's proctologist writing exactly that scrip because Deckard's ass wants to get high.

It could be Deckard's proctologist writing exactly that scrip because Deckard's ass wants to get high.

Scumbag asshole coward.

This isn't about getting high you simpleton.

Chickenshit motherfucker.

Whatever works best for the individual.

five-part test for determining whether a drug is in "currently accepted medical use":

(1) The drug's chemistry must be known and reproducible;

(2) there must be adequate safety studies;

(3) there must be adequate and well-controlled studies proving efficacy;

(4) the drug must be accepted by qualified experts; and

(5) the scientific evidence must be widely available.

57 Fed.Reg. at 10,506.

Rx: Whatever works.

Whatever works best sounds like a plan. If a beer or a shot of scotch works best, get a scrip for it and have health insurance pay for it.

So sayeth the almighty DEA.

How many doctors did the DEA consult with?

The medical opinion of the DHHS is binding on the DEA.

Look at the quacks that you rely on:

Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994)

[8] Moreover, our review of the record convinces us that the Administrator's findings are supported by substantial evidence. See 21 U.S.C. § 877 (1988) (substantial evidence standard applies to findings of fact in rescheduling proceedings). The Final Order canvasses the record at length. It recites the testimony of numerous experts that marijuana's medicinal value has never been proven in sound scientific studies. The Administrator reasonably accorded more weight to the opinions of these experts than to the anecdotal testimony of laymen and doctors on which petitioners relied. The Administrator noted that

[w]ith one exception, none of [these doctors] could identify under oath the scientific studies they swore they relied on. Only one had enough knowledge to discuss the scientific technicalities involved. Eventually, each one admitted he was basing his opinion on anecdotal evidence, on stories he heard from patients, and on his impressions about the drug.

Final Order, 57 Fed.Reg. at 10,502-03.

five-part test for determining whether a drug is in "currently accepted medical use":

Fuck you clown boy.

Like I said, the DEA or any government agency does not decide what medicine works best for an individual.

Rant on with your precious opinions, but the fact remains - the DEA is keeping cannabis as a Schedule I drug simply to protect big pharma.

Scumbag asshole coward.

This isn't about getting high you simpleton.

Chickenshit motherfucker.

Bullshit. This is not about medicine. You just want to go to a quack, say you want something for your head, and get a phony scrip. Next would be getting your Obamacare to pay for it.

To be medicine, a substance, every substance, must pass tests. Marijuana has not.

DEA, 81 FR 53780, August 12, 2016

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).

Fuck you clown boy.

Like I said, the DEA or any government agency does not decide what medicine works best for an individual.

It is the medical and scientific opinions of the DHHS that are binding on the DEA, you ignorant jerk.

Americans for Safe Access, et al., v. Drug Enforcement Administration, No. 11-1265 (D.C. Cir. 22 January 2013) slip op

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).

The government decides what may be lawfully prescribed as medicine and what is illegal to cultivate, distribute or possess.

It is the medical and scientific opinions

ESAD.

Rant on with your precious opinions, but the fact remains - the DEA is keeping cannabis as a Schedule I drug simply to protect big pharma.

And you just want to be able to go to your proctologist and get a scrip to get your ass high.

Marijuana is a schedule drug by international treaty, and federal law, and fails all five prongs of the test for being authorized as medicine.

ESAD.

YMFCSCJSDEKLSOBWBC.

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).

Watch Colorado for an example of what ensues when knuckleheads legalize a hallucigenic drug. Scores of brain-addled numbskulls on the road and when they enter another state the police are always looking for Colorado tags on a car driving erratically.

This is a Pandora's Box!

Piss up a rope psycho.

Oh, you poor little baby....you should try not to get so upset when facts are presented to you.

Try....try hard.

nolu spam posts opinions

Which part of "calling on Congress to legislatively reclassify cannabis" did you not understand, nolu spam?

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.

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

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

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.

It cannot meet the first test to safely prescribe as medicine.

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.''

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.

- - - - - - - - - -

Facts?

nolu spam posts opinions

And you post Yellow Journalism half truths and lies.

Chan makes sense....you make yourself look like the idiot that you are.

nolu spam posts opinions

Deckard posts recycled bullshit over and over.

Articles posted there [FR] aren't to be believed.

LOL! Now, now ... I also was banned from FR*, but however goofy JR and the mods are, it's just not the case that fact becomes fiction simply by being posted to FR.

*Details here if you're interested: http://libertysflame.com/cgi-bin/readart.cgi?ArtNum=45337

Marijuana does not meet any of the five elements necessary for a drug to have a ''currently accepted medical use.''

Are you this stupid, or are you hoping others on LF are? "The five elements" are authoritative because of authority that ultimately derives from Congress and its legislation; when the subject is (urged) Congressional CHANGES to legislation, the CURRENT state of the rules is no longer binding.

Marijuana does not meet any of the five elements necessary for a drug to have a ''currently accepted medical use.''

Are you this stupid, or are you hoping others on LF are? "The five elements" are authoritative because of authority that ultimately derives from Congress and its legislation; when the subject is (urged) Congressional CHANGES to legislation, the CURRENT state of the rules is no longer binding.

I have given up all hope for you. Your brain has apparently been fired on drugs.

reclassify it in a category that, at a minimum will recognize cannabis as a drug with potential medical value.

It is already in a Schedule where it already has been recognized as a substance with potential medical value. It just kind of lacks "currently accepted medical value.

DEA, 81 FR 53779-53781, August 12, 2016

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.

"Are you this stupid, or are you hoping others on LF are? "The five elements" are authoritative because of authority that ultimately derives from Congress and its legislation; when the subject is (urged) Congressional CHANGES to legislation, the CURRENT state of the rules is no longer binding."

I have given up all hope for you.

You've answered my question - you are that stupid.

Poor stupid nolu spam.

Poor stupid nolu spam. ----- ConservingFreedom

The government decides what may be lawfully prescribed as medicine and what is illegal to cultivate, distribute or possess. --- nolu chan

To nolu, (and his buddies here) the government is all powerful and can declare damn near ANYTHING, or any behavior, illegal. - --- This is beyond stupid, -- it is an anti-constitutional theory.

I guess the WWII and Korea Vets are all gone.

Nope - membership is declining because Vietnam vets haven't joined: articles.latimes.com/1998/nov/11/local/me-41612

the government is all powerful and can declare damn near ANYTHING, or any behavior, illegal. - --- This is beyond stupid

Listening to two stoned dopers who believe they are having a conversation is listening to pure stupid.

it is an anti-constitutional theory.

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of really good shit.

Facts?

A friend who is a Vietnam vet, also retired from the California National Guard about 4 years ago.

He has PTSD and has been on prescription psych drugs for about 30 years or more. He called me up a couple of years ago, all jazzed because his VA psychiatrist took him off of all prescription drugs. For the first time in decades he's off of the hated psych meds and drug free, but with California Medical Marijuana as a back up, as needed. He's officially considered cured, and weed helped.

That one story is enough to convince me that MM should be available to all.

A friend who is a Vietnam vet, also retired from the California National Guard about 4 years ago.

He has PTSD and has been on prescription psych drugs for about 30 years or more. He called me up a couple of years ago, all jazzed because his VA psychiatrist took him off of all prescription drugs. For the first time in decades he's off of the hated psych meds and drug free, but with California Medical Marijuana as a back up, as needed. He's officially considered cured, and weed helped.

That one story is enough to convince me that MM should be available to all.

PTSD: National Center for PTSD

Marijuana Use and PTSD among Veterans

Marcel O. Bonn-Miller, Ph.D. and Glenna S. Rousseau, Ph.D.

Marijuana use for medical conditions is an issue of growing concern. Some Veterans use marijuana to relieve symptoms of PTSD and several states specifically approve the use of medical marijuana for PTSD. However, controlled studies have not been conducted to evaluate the safety or effectiveness of medical marijuana for PTSD. Thus, there is no evidence at this time that marijuana is an effective treatment for PTSD. In fact, research suggests that marijuana can be harmful to individuals with PTSD.

Epidemiology

Marijuana use has increased over the past decade. In 2013, a study found that 19.8 million people reported using marijuana in the past month, with 8.1 million using almost every day (1). Daily use has increased 60% in the prior decade (1). A number of factors are associated with increased risk of marijuana use, including diagnosis of PTSD (2), social anxiety disorder (3), other substance use, particularly during youth (4), and peer substance use (5).

Cannabis Use Disorder among Veterans Using VA Health Care

There has been no study of marijuana use in the overall Veteran population. What we do know comes from looking at data of Veterans using VA health care, who may not be representative of Veterans overall. When considering the subset of Veterans seen in VA health care with co-occurring PTSD and substance use disorders (SUD), cannabis use disorder has been the most diagnosed SUD since 2009. The percentage of Veterans in VA with PTSD and SUD who were diagnosed with cannabis use disorder increased from 13.0% in fiscal year (FY) 2002 to 22.7% in FY 2014. As of FY 2014, there are more than 40,000 Veterans with PTSD and SUD seen in VA diagnosed with cannabis use disorder (6).

Problems Associated with Marijuana Use

Marijuana use is associated with medical and psychiatric problems. These problems may be caused by using, but they also may reflect the characteristics of the people who use marijuana. Medical problems include chronic bronchitis, abnormal brain development among early adolescent initiators, and impairment in short-term memory, motor coordination and the ability to perform complex psychomotor tasks such as driving. Psychiatric problems include psychosis and impairment in cognitive ability. Quality of life can also be affected through poor life satisfaction, decreased educational attainment, and increased sexual risk-taking behavior (7). Chronic marijuana use also can lead to addiction, with an established and clinically significant withdrawal syndrome (8).

Active Ingredients and Route of Administration

Marijuana contains a variety of components (cannabinoids), most notably delta-9-tetrahydrocannabinol (THC) the primary psychoactive compound in the marijuana plant. There are a number of other cannabinoids, such as cannabidiol (CBD), cannabinol (CBN), and cannabigerol (CBG). Marijuana can vary in cannabinoid concentration, such as in the ratio of THC to other cannabinoids (CBD in particular). Therefore, the effects of marijuana use (e.g., experience of a high, anxiety, sleep) vary as a function of the concentration of cannabinoids (e.g., THC/CBD). In addition, the potency of cannabinoids can vary. For example, the concentration of THC in the marijuana plant can range in strength from less than 1% to 30% based upon strain and cultivation methods. In general, the potency of THC in the marijuana plant has increased as much as 10- fold over the past 40 years (9,10). Recently, cannabis extract products, such as waxes and oils, have been produced and sold in which the concentration of THC can be as high as 90%. Thus, an individual could unknowingly consume a very high dose of THC in one administration, which increases the risk of an adverse reaction.

Marijuana can be consumed in many different forms (e.g., flower, hash, oil, wax, food products, tinctures). Administration of these forms also can take different routes: inhalation (smoking or vaporizing), ingestion, and topical application. Given the same concentration/ratio of marijuana, smoking or vaporizing marijuana produces similar effects (11); however, ingesting the same dose results in a delayed onset and longer duration of effect (12). Not all marijuana users may be aware of the delayed effect caused by ingestion, which may result in greater consumption and a stronger effect than intended.

Neurobiology

Research has consistently demonstrated that the human endocannabinoid system plays a significant role in PTSD. People with PTSD have greater availability of cannabinoid type 1 (CB1) receptors as compared to trauma-exposed or healthy controls (13,14). As a result, marijuana use by individuals with PTSD may result in short-term reduction of PTSD symptoms. However, data suggest that continued use of marijuana among individuals with PTSD may lead to a number of negative consequences, including marijuana tolerance (via reductions in CB1 receptor density and/or efficiency) and addiction (15). Though recent work has shown that CB1 receptors may return after periods of marijuana abstinence (16), individuals with PTSD may have particular difficulty quitting (17).

Marijuana as a Treatment for PTSD

The belief that marijuana can be used to treat PTSD is limited to anecdotal reports from individuals with PTSD who say that the drug helps with their symptoms. There have been no randomized controlled trials, a necessary "gold standard" for determining efficacy. Administration of oral CBD has been shown to decrease anxiety in those with and without clinical anxiety (18). This work has led to the development and testing of CBD treatments for individuals with social anxiety (19), but not yet among individuals with PTSD. With respect to THC, one open trial of 10 participants with PTSD showed THC was safe and well tolerated and resulted in decreases in hyperarousal symptoms (20).

Treatment for Marijuana Addiction

People with PTSD have particular difficulty stopping their use of marijuana and responding to treatment for marijuana addiction. They have greater craving and withdrawal than those without PTSD (21), and greater likelihood of marijuana use during the six months following a quit attempt (17). However, these individuals can benefit from the many evidence-based treatments for marijuana addiction, including cognitive behavioral therapy, motivational enhancement, and contingency management (22). Thus, providers should still utilize these options to support reduction/abstinence.

Clinical Recommendations

Treatment providers should not ignore marijuana use in their PTSD patients. The VA/DoD PTSD Clinical Practice Guideline (2010) recommends providing evidence-based treatments for the individual disorders concurrently. PTSD providers should offer education about problems associated with long-term marijuana use and make a referral to a substance use disorder (SUD) specialist if they do not feel they have expertise in treating substance use.

Individuals with comorbid PTSD and SUD do not need to wait for a period of abstinence before addressing their PTSD. A growing number of studies demonstrate that that these patients can tolerate trauma-focused treatment and that these treatments do not worsen substance use outcomes. Therefore, providers have a range of options to help improve the lives of patients with the co-occurring disorders. For more information, see PTSD and Substance Use Disorders in Veterans.

References

1. SAMHSA. (2014). Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. (Vol. NSDUH Series H-48, HHS Publication No. (SMA) 13-4795). Rockville, MD: Substance Abuse and Mental Health Services Administration.

2. Cougle, J.R., Bonn-Miller, M. O., Vujanovic, A. A., Zvolensky, M. J., & Hawkins, K. A. (2011). Posttraumatic stress disorder and cannabis use in a nationally representative sample. Psychology of Addictive Behaviors, 25, 554-558. doi: 10.1037/a0023076

3. Buckner, J.D., Schmidt, N. B., Lang, A. R., Small, J. W., Schluach, R. C., & Lewinsohn, P. M. (2008). Specificity of social anxiety disorder as a risk factor for alcohol and cannabis dependence. Journal of Psychiatric Research, 42, 230-239. doi: 10.1016/j.jpsychires.2007.01.002

4. Butterworth, P., Slade, T. & Degenhardt, L. (2014). Factors associated with the timing and onset of cannabis use and cannabis use disorder: Results from the 2007 Australian National Survey of Mental Health and Well-Being. Drug and Alcohol Review, 33, 555-564. doi: 10.1111/dar.12183

5. von Sydow, K., Lieb, R., Pfister, H., Höefler, M., & Wittchen, H. U. (2002). What predicts incident use of cannabis and progression to abuse and dependence? A 4-year prospective examination of risk factors in a community sample of adolescents and young adults. Drug and Alcohol Dependence, 68, 49-64.

6. Program Evaluation and Resource Center, V.A., 2015.

7. Volkow, N. D., Baler, R. D., Compton, W. M., & Weiss, S. R. B. (2014). Adverse health effects of marijuana use. New England Journal of Medicine, 370, 2219-2227. doi: 10.1056/NEJMra1402309

8. Budney, A. J., Hughes, J. R., Moore, B. A., & Vandrey, R. (2004). Review of the validity and significance of cannabis withdrawal syndrome. American Journal of Psychiatry, 161, 1967-1977.

9. Mehmedic, Z., Chandra, S., Slade, D., Denham, H., Foster, S., Patel, A. S., Ross, S. A., Khan, I. A., & ElSohly, M. A. (2010). Potency trends of ”9-THC and other cannabinoids in confiscated cannabis preparations from 1993 to 2008. Journal of Forensic Sciences, 55, 1209-1217. doi: 10.1111/j.1556-4029.2010.01441.x

10. Sevigny, E. L., Pacula, R. L., & Heaton, P. (2014) The effects of medical marijuana laws on potency. International Journal of Drug Policy, 25, 308-319. doi: 10.1016/j.drugpo.2014.01.003

11. Abrams, D. I., Vizoso, H. P., Shade, S. B., Jay, C., Kelly, M. E., & Benowitz, N. L. (2007). Vaporization as a smokeless cannabis delivery system: A pilot study. Clinical Pharmacology & Therapeutics, 82, 572-578.

12. Grotenhermen, F. (2003). Pharmacokinetics and pharmacodynamics of cannabinoids. Clinical Pharmacokinetics, 42, 327-360.

13. Neumeister, A., Normandin, M. D., Pietrzak, R. H., Piomelli, D., Zheng, M. Q., Gujarro-Anton, A., Potenza, M. N., Bailey, C. R., Lin, S. F., Najafzaden, S., Ropchan, J., Henry, S., Corsi-Travali, S., Carson, R. E., & Huang, Y. (2013). Elevated brain cannabinoid CB1 receptor availability in post-traumatic stress disorder: A positron emission tomography study. Molecular Psychiatry, 18, 1034-1040. doi: 10.1038/mp.2013.61

14. Passie, T., Emrich, H. M., Brandt, S. D., & Halpern, J. H. (2012). Mitigation of post-traumatic stress symptoms by Cannabis resin: A review of the clinical and neurobiological evidence. Drug Testing and Analysis, 4, 649-659. doi: 10.1002/dta.1377

15. Kendall, D.A. & Alexander, S.P. H. (2009). Behavioral neurobiology of the endocannabinoid system. Current topics in behavioral neurosciences. Heidelberg: Springer-Verlag.

16. Hirvonen, J., Goodwin, R. S., Li, C-T., Terry, G. E., Zoghbi, S. S., Morse, C., Pike, V. W., Volkow, N. D., Huestis, M. A., & Innis, R. B. (2012). Reversible and regionally selective downregulation of brain cannabinoid CB1 receptors in chronic daily cannabis smokers. Molecular Psychiatry, 17, 642-649. doi: 10.1038/mp.2011.82

17. Bonn-Miller, M. O., Moos, R. H., Boden, M. T., Long, W. R., Kimerling, R., & Trafton, J. A. (in press). The impact of posttraumatic stress disorder on cannabis quit success. The American Journal of Drug and Alcohol Abuse.

18. Crippa, J. A., Zuardi, A. W., Martìn-Santos, R., Bhattacharyya, S., Atakan, Z., McGuire, P., & Fusar-Poli, P. (2009). Cannabis and anxiety: a critical review of the evidence. Human Psychopharmacology, 24, 515-523. doi: 10.1002/hup.1048

19. Bergamaschi, M. M., Queiroz, R. H. C., Hortes, M., Chagas, N., de Oliveira, C. G., De Martinis, B. S., Kapczinski, F., Quevedo, J., Roesler, R., Schröder, N., Nardi, A. E., Martín-Santos, R., Hallak, J. E. C., Zuardi, A. W., & Crippa, J. A. S. (2011). Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naïve social phobia patients. Neuropsychopharmacology, 36, 1219-1226. doi: 10.1038/npp.2011.6

20. Roitman, P., Mechoulam, R., Cooper-Kazaz, R., & Shalev, A. (2014). Preliminary, open-label, pilot study of add-on oral ”9- tetrahydrocannabinol in chronic post-traumatic stress disorder. Clinical Drug Investigation, 34, 587-591. doi: 10.1007/s40261-014-0212-3

21. Boden, M. T., Babson, K. A., Vujanovic, A. A., Short, N. A., & Bonn- Miller, M. (2013). Posttraumatic stress disorder and cannabis use characteristics among military Veterans with cannabis dependence. The American Journal on Addictions, 22, 277-284. doi: 10.1111/j.1521- 0391.2012.12018.x

22. Roffman, R. A. & Stephens, R. S. (2006). Cannabis dependence: its nature, consequences, and treatment. International research monographs in the addictions. Cambridge, UK; New York: Cambridge University Press.

http://www.ptsd.va.gov/professional/c o-occurring/marijuana_use_ptsd_veterans.asp.