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Title: GovtÂ’s Own Research Shows Legalization NOT Prohibition Dramatically Reduces Drug Use
Source: Free Thought Project
URL Source: http://thefreethoughtproject.com/go ... ohibition/#m4yujmbge3R3bfiW.99
Published: Sep 8, 2016
Author: Justin Gardner
Post Date: 2016-09-08 20:36:28 by Deckard
Keywords: None
Views: 898
Comments: 11

In 2014, after Colorado legalized the recreational use of cannabis, we began hearing that teen use was declining – contrary to prohibitionist propaganda. Real-world data were beginning to prove that the black market, created through government prohibition, is a prime driver of negativities associated with drugs.

Another study performed by Washington University School of Medicine, published in May of this year, found that teen use of cannabis has significantly decreased as states legalize cannabis. This is good news, as the abuse of any psychoactive drug, even the relatively benign cannabis plant, can harm the developing adolescent brain. However, the controlled application of medical cannabis extracts such as CBD oil has profound benefits for debilitating conditions such as epilepsy.

Now, the government’s own research has confirmed that teen cannabis use has fallen dramatically since the legalization movement began picking up steam with the turn of the century. The Centers for Disease Control (CDC) analyzed data from 2002-2014 and found that access to cannabis among teens has dropped as the black market declines.

“In addition, despite increased perceptions of no risk from smoking marijuana, obtaining marijuana nationally remains more difficult for persons aged 12−17 years than for those aged ≥18, which could explain the lower prevalence of marijuana use and initiation in this age group. In fact, since 2002 the perceived availability (i.e., fairly easy or very easy to obtain marijuana) among persons aged 12–17 and 18–25 years has decreased.”

Perhaps removing the mystery of an “illicit” plant and bringing it into the open, where it should be, plays a part in decreasing the attraction. People have used cannabis for thousands of years, and only in the last century did the State suddenly deem this medicinal plant illegal – for reasons that have nothing to do with safety and everything to do with corruption and racism.

This idea that legalization and decriminalization decrease use is nothing new. While the idea of treating an addict with compassion instead of violence is a revolutionary notion in this country, this criminal ignorance doesn’t exist everywhere. In other countries, such as Portugal, its effects have been realized for more than a decade. In 2001, the Portuguese government decriminalized all drugs.

15 years later, drug use, crime, and overdoses have drastically declined in Portugal exposing the disturbing reality of prohibition.

The CDC study found another positive trend in its examination of cannabis use among the general population. While moderate use among adults is up since 2002, the abuse or dependence on cannabis has decreased with legalization.

“Although NSDUH data suggest increases in daily and almost daily use among adults (both in the overall population and among adult marijuana users), they also suggest steady decreases in the prevalence of marijuana dependence and abuse among adult marijuana users since 2002.”

Abuse or dependence is tricky to define when it comes to cannabis, considering that it provides medicinal properties for a range of physical and mental conditions. For example, those suffering from Crohn’s disease will find relief from smoking a joint just as they would ingesting a medical grade cannabis product. War veterans suffering from post-traumatic stress disorder may find daily relief through cannabis use where prescription medications have failed.

This may be called dependence, but it is a dependence that prevents them from harming themselves or others. It is not the same as a dependence on alcohol, which does not have the medicinal benefits that cannabis brings through stimulating the endocannabinoid system.

Part of the explanation for the increase in “daily and almost daily use among adults” is most likely that more and more people are recognizing the medicinal benefits of cannabis. 25 states have now legalized some form of medical use.

Indeed, in states where medical cannabis is legalized, people are abandoning prescription pills in favor of the miraculous plant. Opioid abuse is also decreasing in states with legal weed.

The CDC study is of particular interest because the DEA just reaffirmed its prohibition of cannabis, maintaining the position that it has “no currently accepted medical use and a high potential for abuse.” We know the first part is absurdly wrong, as proof of its medical value is indisputable, and now the government’s own study shows that the “potential for abuse” is higher under prohibition.

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#2. To: Deckard (#0)

The CDC study is of particular interest because the DEA just reaffirmed its prohibition of cannabis, maintaining the position that it has “no currently accepted medical use and a high potential for abuse.” We know the first part is absurdly wrong, as proof of its medical value is indisputable, and now the government’s own study shows that the “potential for abuse” is higher under prohibition.

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).’’

nolu chan  posted on  2016-09-09   1:01:58 ET  Reply   Untrace   Trace   Private Reply  


#4. To: nolu chan (#2)

Your spam is not relevant to the topic of the article.

Deckard  posted on  2016-09-09   7:50:25 ET  Reply   Untrace   Trace   Private Reply  


#6. To: Deckard (#4)

Your spam is not relevant to the topic of the article.

Is it ever? copying and pasting is all nolu spam knows how to do.

ConservingFreedom  posted on  2016-09-09   11:16:36 ET  Reply   Untrace   Trace   Private Reply  


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