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Title: Former Cop Tries Cannabis as Last Resort to Treat Parkinson’s Disease
Source:
Daily Sheeple
URL Source: http://www.thedailysheeple.com/watc ... reat-parkinsons-disease_122016
Published: Dec 1, 2016
Author: Carey Wedler
Post Date: 2016-12-02 21:28:11 by Deckard
Keywords: None
Views: 30173
Comments: 101
As research and anecdotal evidence increasingly indicate cannabis has medical benefits, a new series of videos from a man suffering from Parkinson’s disease highlights just how vital the plant can be. Larry Smith, a former police officer, began to suffer from the debilitating neurological disease twenty years ago. In 2011, filmmakers began documenting his experience for the upcoming film, Ride with Larry. The documentary and accompanying awareness campaign “seeks to enlighten audiences to the human cost of Parkinson’s disease while providing insights into the tangible benefits of an active lifestyle, particularly through recumbent cycling,” according to the film’s Facebook page. More recently, Larry began to experiment with medical marijuana to treat his worsening symptoms. In a video uploaded to Ride with Larry’s Facebook page last week, he arrives in San Diego, California, to obtain a license. “My symptoms are a great deal more obvious than ever before, and the pain is a little sharper,” Larry says with some difficulty speaking. “Larry’s at the point where he’s having so much trouble walking, now he takes twenty pills a day,” his wife Elizabeth explains, noting that increasing the dose could increase the side effects. While in San Diego, Larry and his wife visit a medical marijuana doctor to obtain a prescription. “These are not the days of Reefer Madness,” Larry observes in the video, referencing a 1936 propaganda film meant to demonize cannabis use. “Yet I and millions of other people can’t have it without facing serious jail time.” Larry currently lives in South Dakota, which does not have a medical marijuana program. In Part 2 of the series, Larry uses his prescription to purchase $40 worth of the plant at a dispensary in an attempt to ease his pain and rigid joints. Elizabeth tells the “budtender” at the dispensary that the side effects of Larry’s pills have actually contributed to his dyskinesia. Further, she also discloses that every time she fills a prescription for him, it costs about $3,000, pointing out the stark difference in cost between pharmaceuticals and cannabis. Though in Part 2, Larry buys actual buds, in Part 3 of 3, he meets with another man suffering from Parkinson’s disease who gives him cannabis oil to place under his tongue. His relief is almost instantaneous. “With a few drops of cannabis oil under his tongue, Larry’s severe dyskinesia (uncontrolled movements), loss of voice, and tremors are calmed within in minutes! We didn’t even edit the footage because the results were so startling.” Sure enough, the footage shows Larry placing the drops under his tongue before lying down. After just a few minutes, he sits up and it becomes apparent his uncontrolled movements have largely ceased. His friend says, “I think you’ve calmed down.” Larry simply says, “So quickly,” as a smile comes over his face. “My voice is coming back,” he also observes. In a voiceover, Elizabeth notes how his hands became “rock steady” after he tried the treatment. “It works most of the time,” his friend observes after he sits up. Larry imitates the sound of a heavenly choir to demonstrate his immense relief. “Did you guys eat lunch?” he asks the others in the room. “You hungry now?” his friend with Parkinson’s inquires. “Funny, I am,” he replies. As the video ends, Larry observes that “A person like me could really use marijuana. And it makes me pretty angry that I can’t get it in my home state.” At least one academic expert shares this frustration. As Dr. Daniele Piomelli, a professor of Pharmacology at UC Irvine’s medical school, says in Part 3 of Larry’s series: “The number one frustration that I have is knowing that there is this untapped potential — that comes from what marijuana is teaching us — to generate new medicines, and being stuck because of financial issues or political issues. That is extremely frustrating.” Dr. Piomelli, who runs a lab at the university, discussed recent research on cannabis’ effect on Parkinson’s disease: “We know from animal experiments that the endogenous cannabinoid system is very important [in] regulating motor activity, the very type of activity that is impaired in Parkinson’s disease. From animal experiments, we also know that boosting certain branches of the endocannabinoid system is helpful in relieving symptoms of Parkinson’s. Finally, from anecdotal information, we know that certain patients who smoke marijuana experience relief [from] their symptoms.” Further, a 2014 study published in Clinical Neuropharmacology, researchers concluded there was “significant improvement of sleep and pain scores” for patients using cannabis to treat Parkinson’s. They noted “no significant adverse effects of the drug were observed” but cautioned further research was necessary. A 2014 study published in the Journal of Psychopharmacology explained that cannabidiol, or CBD, a non-psychoactive endocannabinoid, had the possible effect of “improving quality of life measures in PD patients with no psychiatric comorbidities.” They also advised more research was needed. Even without the scientific research to back up the plant’s effectiveness, Larry’s experience may provide hope to countless others suffering from debilitating ailments (Part 3 has been viewed over 20 million times as of this article’s publication). Though cannabis is becoming legal in a growing number of states, many people suffering from illnesses are unable to access the treatment. As Elizabeth said in Part 1: “I do not like the idea of breaking federal law. Even though the state law in California is very clear that it’s permissible, I’m still uncomfortable. But, you know, if this is the only thing — and as far as I know we’ve tried everything, and this is the only thing that’s left…we are going to give it a go and see how it goes.” And as she says in Part 3 after witnessing her husband finally experience relief: “We now know that medical marijuana controls dyskinesia, and yet it’s not available to us.” Still, as stories like Larry’s continue to accumulate and the war on a plant continues to fail, the trend of legalization throughout the United States shows no signs of stopping. Delivered by The Daily Sheeple
According to the video’s description:
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Begin Trace Mode for Comment # 45.
#1. To: Deckard (#0)
Marijuana should never be thought of as a replacement for dopaminergic and other approved therapies for Parkinson's disease.
Yes, $3000 a month for the Big Pharma cannot be replaced.
paulsen (misterwhite) must be heavily invested in Big Pharma. Why else would he deny the proven benefits of medical cannabis and want to keep it banned?
Proven? Anecdotal stories are not proof.
Clinical Studies and Case Reports It does not count when one doper says he has been peer reviewed by another doper when the test is rejected by official authorities. That counts for zero and any possession or use of marijauna remains a Federal crime. 81 Fed Reg No 156 (12 Aug 2016) 53767-53845, Proposed Rules Denial, Docket DEA-427 (https://clinicaltrials.gov/ct2/about-site/background). ClinicalTrials.gov was searched for all studies administering marijuana. The results of this search were used to confirm that no completed studies with published data were missed in the literature search. During the literature search, references found in relevant studies and systematic reviews were evaluated for additional relevant citations. All languages were included in the search. The PubMed search yielded a total of 566 abstracts. Of these abstracts, a full-text review was conducted with 85 papers to assess eligibility. From this evaluation, only eleven of 85 studies met the 6 CFR elements for inclusion as adequate and well-controlled studies. None of the 11 adequate and well controlled studies proved efficacy. 74 studies failed to meet the standards of adequate and well-controlled studies.
Clinical Studies and Case Reports It does not count when one doper says he has been peer reviewed by another doper when the test is rejected by official authorities You obviously didn't even look at those two sources. Typical government apologist.
I don't have to look at your bullshit sources when the sole official source capable of approving the tests, or the drug, states that there has been no test whatsoever that has met the required standards and shown efficacy. Typical doper whose brain is too fried to think. Argued to a court, this peer-reviewed bullshit gets destroyed like a doper's brain. Americans for Safe Access v DEA (excerpt) peer review bs DHHS makes the scientific and medical evaluations. If and when the effectiveness of kratom is established in well-controlled, well-designed, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients, they may give your insatiable desires high consideration. You are like a teen who does not take a road test but goes to the DMV for a drivers license and presents notes from various friends, neighbors, and mommy attesting to your being a safe driver. You do not get a license without a road test. DMV to Deckard: Because we say so. Americans for Safe Access et al v. DEA, 11-1265 (D.C. Cir. 22 Jan 2013) At 23: At 26-28: Contrary to what Petitioners suggest, something more than “peer-reviewed” studies is required to satisfy DEA’s standard, and for good reason. “[S]cientists understand that peer review per se provides only a minimal assurance of quality, and that the public conception of peer review as a stamp of authentication is far from the truth.” Charles Jennings, Quality and Value: The True Purpose of Peer Review, NATURE.COM (2006), http://www.nature.com/nature/ peerreview/debate/nature05032.html; see also Lynn S. McCarty et al., Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice, 120 ENVTL. HEALTH PERSP. 927, 930 (2012) (“It is difficult to extract from the extensive body of work and commentary published over the last 25-30 years that scientific journal peer review is a coherent, consistent, reliable, evaluative procedure. . . . [T]he opposite conclusion may be more accurate.”). Petitioners may have cited some peer–reviewed articles in support of their position, but they have not pointed to “adequate and well-controlled studies” confirming the efficacy of marijuana for medicinal uses. If, as is the case here, “there is substantial evidence to support the [agency’s] finding that the[] studies [offered by petitioner] are not helpful, then petitioner must fail.” Unimed, Inc. v. Richardson, 458 F.2d 787, 789 (D.C. Cir. 1972). In making this assessment, we must “remind ourselves that our role in the Congressional scheme is not to give an independent judgment of our own, but rather to determine whether the expert agency entrusted with regulatory responsibility has taken an irrational or arbitrary view of the evidence assembled before it.” Id. The DEA’s construction of its regulation is eminently reasonable. Therefore, we are obliged to defer to the agency’s interpretation of “adequate and well-controlled studies.” See Thomas Jefferson Univ., 512 U.S. at 512 (deferring to “an agency’s interpretation of its own regulations”). Judged against the DEA’s standard, we find nothing in the record that could move us to conclude that the agency failed to prove by substantial evidence that such studies confirming marijuana’s medical efficacy do not exist. Finally, Petitioners suggested during oral argument that the Government had foreclosed the research that would be necessary to create sufficiently reliable clinical studies of marijuana’s medical efficacy. Because Petitioners did not properly raise this issue with the DEA and there is nothing in the record to support it, we do not consider it here. We note, however, that DHHS’ recommendation explained that “[t]he opportunity for scientists to conduct clinical research with marijuana exists under the [D]HHS policy supporting clinical research with botanical marijuana.” Denial, 76 Fed. Reg. at 40,562. Thus, it appears that adequate and well-controlled studies are wanting not because they have been foreclosed but because they have not been completed.
Well, you may choose to not look at Deckard's sources but I just so happened to stumble upon an article written by The Journal of American Medical Association that contradicts what DHHS has to say about cannabis. Had my mom been prescribing to cannabis rather than the continuous chemo treatments she was getting, she would be still be alive today. And what's worse is that at the same time she was getting those chemo treatments, those same doctors were administering flu shots on her which caused her to go code blue. So, I don't put too much faith on most doctors medicine these days.
And remains unlawful with no accepted medical use. There is one regulating body and it is not JAMA or Dopers Are Us. No amount of self-professed but unofficial claims of "peer reviewed" articles will satisfy the conditions placed upon every medical substance in the country. Some time back, laetrile, from peach pits, was the miracle cure. Sorry about your mom, but there is no way to know that marijuana would have worked where chemo failed. If you choose, you are free to prefer witch doctors or dopers who profess that marijuana is the miracle cure for everything, or a Mexican clinic dispensing laetrile. If marijuana is the miracle cure, I should think the cancer rate in Columbia should be near zero. Americans for Safe Access et al v. DEA, 11-1265 (D.C. Cir. 22 Jan 2013)
Are you a real person or a machine? From that case you cited, I quote in part: "On the merits, the question before the court is not whether marijuana could have some medical benefits. Rather, the limited question that we address is whether the DEA’s decision declining to initiate proceedings to reschedule marijuana under the CSA was arbitrary and capricious. These questions are not coterminous. “The scope of review under the ‘arbitrary and capricious’ standard is narrow and a court is not to substitute its judgment for that of the agency.” Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). On the record before us, we hold that the DEA’s denial of the rescheduling petition survives review under the deferential arbitrary and capricious standard. The petition asks the DEA to reclassify marijuana as a Schedule III, IV, or V drug, which, under the terms of the CSA, requires a “currently accepted medical use.” The DEA’s regulations, which we approved in Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994), define “currently accepted medical use” to require, inter alia, “adequate and well-controlled studies proving efficacy.” Id. at 1135. We defer to the agency’s interpretation of these regulations and find that substantial evidence supports its determination that such studies do not exist." Not only do those studies exist but I just cited those findings.
From that case you cited, I quote in part: "On the merits, the question before the court is not whether marijuana could have some medical benefits. Rather, the limited question that we address is whether the DEA’s decision declining to initiate proceedings to reschedule marijuana under the CSA was arbitrary and capricious. These questions are not coterminous. “The scope of review under the ‘arbitrary and capricious’ standard is narrow and a court is not to substitute its judgment for that of the agency.” Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). On the record before us, we hold that the DEA’s denial of the rescheduling petition survives review under the deferential arbitrary and capricious standard. The petition asks the DEA to reclassify marijuana as a Schedule III, IV, or V drug, which, under the terms of the CSA, requires a “currently accepted medical use.” The DEA’s regulations, which we approved in Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994), define “currently accepted medical use” to require, inter alia, “adequate and well-controlled studies proving efficacy.” Id. at 1135. We defer to the agency’s interpretation of these regulations and find that substantial evidence supports its determination that such studies do not exist." Not only do those studies exist but I just cited those findings. Are you a brain-damaged kangaroo? Read the first sentence for context. You did not cite any adequate and well-controlled study proving efficacy. There are no adequate and well-controlled studies proving efficacy. There are NO SUCH studies. There is only (a) doper bullshit that does not qualify as adequate and well-controlled studies that have claimed to prove efficacy, and (b) adequate and well-controlled studies that do not prove efficacy. A group of dopers on a mission, engaging in a self-congratulatory circle jerk, is a qualified peer-reviewed article in the same way that this site's dopers congratulating each other's profound discoveries is certification of scientific merit. DEA: "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." DEA, 81 FR 53779-53781, August 12, 2016 State-level public initiatives, including laws and referenda in support of the medical use of marijuana, have generated interest in the medical community and the need for high quality clinical investigation as well as comprehensive safety and effectiveness data. In order to address the need for high quality clinical investigations, the state of California established the Center for Medicinal Cannabis Research (CMCR, www.cmcr.ucsd.edu) in 2000 ''in response to scientific evidence for therapeutic possibilities of cannabis[9] and local legislative initiatives in favor of compassionate use'' (Grant, 2005). State legislation establishing the CMCR called for high quality medical research that would ''enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent,'' but stressed the project ''should not be construed as encouraging or sanctioning the social or recreational use of marijuana.'' The CMCR funded many of the published studies on marijuana's potential use for treating multiple sclerosis, neuropathic pain, appetite suppression and cachexia. However, aside from the data produced by CMCR, no state-level medical marijuana laws have produced scientific data on marijuana's safety and effectiveness. FDA approves medical use of a drug following a submission and review of an NDA or BLA. The FDA has not approved any drug product containing marijuana for marketing. Even so, results of small clinical exploratory studies have been published in the current medical literature. Many studies describe human research with marijuana in the United States under FDA-regulated IND applications. However, FDA approval of an NDA is not the only means through which a drug can have a currently accepted medical use in treatment in the United States. In general, a drug may have a ''currently accepted medical use'' in treatment in the United States if the drug meets a five-part test. Established case law (Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994)) upheld the Administrator of DEA's application of the five-part test to determine whether a drug has a ''currently accepted medical use.'' The following describes the five elements that characterize ''currently accepted medical use'' for a drug[10]: i. the drug's chemistry must be known and reproducible ii. there must be adequate safety studies iii. there must be adequate and well- controlled studies proving efficacy iv. the drug must be accepted by qualified experts v. the scientific evidence must be widely available Marijuana does not meet any of the five elements necessary for a drug to have a ''currently accepted medical use.'' Firstly, the chemistry of marijuana, as defined in the petition, is not reproducible in terms of creating a standardized dose. The petition defines marijuana as including all Cannabis cultivated strains. Different marijuana samples derived from various cultivated strains may have very different chemical constituents including delta9-THC and other cannabinoids (Appendino et al., 2011). As a consequence, marijuana products from different strains will have different safety, biological, pharmacological, and toxicological profiles. Thus, when considering all Cannabis strains together, because of the varying chemical constituents, reproducing consistent standardized doses is not possible. Additionally, smoking marijuana currently has not been shown to allow delivery of consistent and reproducible doses. However, if a specific Cannabis strain is grown and processed under strictly controlled conditions, the plant chemistry may be kept consistent enough to produce reproducible and standardized doses. As to the second and third criteria; there are neither adequate safety studies nor adequate and well-controlled studies proving marijuana's efficacy. To support the petitioners' assertion that marijuana has accepted medical use, the petitioners cite the American Medical Association's (AMA) 2009 report entitled ''Use of Cannabis for Medicinal Purposes.'' The petitioners claim the AMA report is evidence the AMA accepts marijuana's safety and efficacy. However, the 2009 AMA report clarifies that the report ''should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the same and current standards for a prescription drug product.[11]'' Currently, no published studies conducted with marijuana meet the criteria of an adequate and well-controlled efficacy study. The criteria for an adequate and well-controlled study for purposes of determining the safety and efficacy of a human drug are defined under the Code of Federal Regulations (CFR) in 21 CFR 314.126. In order to assess this element, FDA conducted a review of clinical studies published and available in the public domain before February, 2013. Studies were identified through a search of PubMed[12] for articles published from inception to February 2013, for randomized controlled trials using marijuana to assess marijuana's efficacy in any therapeutic indication. Additionally, the review included studies identified through a search of bibliographic references in relevant systematic reviews and identified studies presenting original research in any language. Selected studies needed to be placebo-controlled and double-blinded. Additionally, studies needed to encompass administered marijuana plant material. There was no requirement for any specific route of administration, nor any age limits on study subjects. Studies were excluded that used placebo marijuana supplemented by the addition of specific amounts of THC or other cannabinoids. Additionally, studies administering marijuana plant extracts were excluded. The PubMed search yielded a total of 566 abstracts of scientific articles. Of these abstracts, a full-text review was conducted with 85 papers to assess eligibility. Of the studies identified through the search of the references and the 566 abstracts from the PubMed search, only 11 studies met all the criteria for selection (Abrams et al., 2007; Corey-Bloom et al., 2012; Crawford and Merritt, 1979; Ellis et al., 2009; Haney et al., 2005; Haney et al., 2007; Merritt et al., 1980; Tashkin et al., 1974; Ware et al., 2010; Wilsey et al., 2008; Wilsey et al., 2013). These 11 studies were published between 1974 and 2013. Ten of these studies were conducted in the United States and one study was conducted in Canada. The identified studies examine the effects of smoked and vaporized marijuana for the indications of chronic neuropathic pain, spasticity related to Multiple Sclerosis (MS), appetite stimulation in human immunodeficiency virus (HIV) patients, glaucoma, and asthma. All studies used adult subjects. The 11 identified studies were individually evaluated to determine if they successfully meet accepted scientific standards. Specifically, they were evaluated on study design including subject selection criteria, sample size, blinding techniques, dosing paradigms, outcome measures, and the statistical analysis of the results. The analysis relied on published studies, thus information available about protocols, procedures, and results were limited to documents published and widely available in the public domain. The review found that all 11 studies that examined effects of inhaled marijuana do not currently prove efficacy of marijuana in any therapeutic indication based on a number of limitations in their study design; however, they may be considered proof of concept studies. Proof of concept studies provide preliminary evidence on a proposed hypothesis involving a drug's effect. For drugs under development, the effect often relates to a short-term clinical outcome being investigated. Proof of concept studies often serve as the link between preclinical studies and dose ranging clinical studies. Thus, proof of concept studies generally are not sufficient to prove efficacy of a drug because they provide only preliminary information about the effects of a drug. In addition to the lack of published adequate and well-controlled efficacy studies proving efficacy, the criteria for adequate safety studies has also not been met. Importantly, in its discussion of the five-part test used to determine whether a drug has a ''currently accepted medical use,'' DEA said, ''No drug can be considered safe in the abstract. Safety has meaning only when judged against the intended use of the drug, its known effectiveness, its known and potential risks, the severity of the illness to be treated, and the availability of alternative remedies'' (57 FR 10504). When determining whether a drug product is safe and effective for any indication, FDA performs an extensive risk-benefit analysis to determine whether the risks posed by the drug product's side effects are outweighed by the drug product's potential benefits for a particular indication. Thus, contrary to the petitioner's assertion that marijuana has accepted safety, in the absence of an accepted therapeutic indication which can be weighed against marijuana's risks, marijuana does not satisfy the element for having adequate safety studies such that experts may conclude that it is safe for treating a specific, recognized disorder. The fourth of the five elements for determining ''currently accepted medical use'' requires that the national community of experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, accepts the safety and effectiveness of the substance for use in treating a specific, recognized disorder. A material conflict of opinion among experts precludes a finding of consensus. Medical practitioners who are not experts in evaluating drugs are not qualified to determine whether a drug is generally recognized as safe and effective or meets NDA requirements (57 FR 10499-10505). There is no evidence that there is a consensus among qualified experts that marijuana is safe and effective for use in treating a specific, recognized disorder. As discussed above, there are not adequate scientific studies that show marijuana is safe and effective in treating a specific, recognized disorder. In addition, there is no evidence that a consensus of qualified experts have accepted the safety and effectiveness of marijuana for use in treating a specific, recognized disorder. Although medical practitioners are not qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, we also note that the AMA's report, entitled ''Use of Cannabis for Medicinal Purposes,'' does not accept that marijuana currently has accepted medical use. Furthermore, based on the above definition of a ''qualified expert'', who is an individual qualified by scientific training and experience to evaluate the safety and effectiveness of a drug, state-level medical marijuana laws do not provide evidence of a consensus among qualified experts that marijuana is safe and effective for use in treating a specific, recognized disorder. As to the fifth part of the test, which requires that information concerning the chemistry, pharmacology, toxicology, and effectiveness of marijuana to be reported in sufficient detail, the scientific evidence regarding all of these aspects is not available in sufficient detail to allow adequate scientific scrutiny. Specifically, the scientific evidence regarding marijuana's chemistry in terms of a specific Cannabis strain that could produce standardized and reproducible doses is not currently available. Alternately, a drug can be considered to have a ''currently accepted medical use with severe restrictions'' (21 U.S.C. 812(b)(2)(B)), as allowed under the stipulations for a Schedule II drug. Yet, as stated above, currently marijuana does not have any accepted medical use, even under conditions where its use is severely restricted. In conclusion, to date, research on marijuana's medical use has not progressed to the point where marijuana is considered to have a ''currently accepted medical use'' or a ''currently accepted medical use with severe restrictions.'' - - - - - - - - - - [9] In this quotation the term cannabis is interchangeable with marijuana. [10] 57 FR I 0499, 10504–06 (March 26, 1992). [11] In this quotation the term cannabis is used interchangeably for marijuana. [12] The following search strategy was used, ‘‘(cannabis OR marijuana) AND (therapeutic use OR therapy) AND (RCT OR randomized controlled trial OR ‘‘systematic review’’ OR clinical trial OR clinical trials) NOT (‘‘marijuana abuse’’[Mesh] OR addictive behavior OR substance related disorders).’’
There are no replies to Comment # 45. End Trace Mode for Comment # 45.
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-- Dr. Michael S. Okun, National Medical Director, National Parkinson Foundation
#4. To: misterwhite (#1)
Marijuana should never be thought of as a replacement for dopaminergic and other approved therapies for Parkinson's disease.
#13. To: A Pole (#4)
(Edited)
Yes, $3000 a month for the Big Pharma cannot be replaced.
#20. To: Deckard (#13)
"Why else would he deny the proven benefits of medical cannabis"
#28. To: misterwhite (#20)
Proven? Anecdotal stories are not proof.
#32. To: Deckard, misterwhite (#28)
60 Peer-Reviewed Studies on Medical Marijuana
marijuana has no ‘‘currently accepted medical use’’ because: As detailed in the HHS evaluation, the drug’s chemistry is not known and reproducible; there are no adequate safety studies;
there are no adequate and well-controlled studies proving efficacy
ClinicalTrials.gov is a database of publicly and privately supported clinical studies that is maintained by the NLM. Information about the clinical studies is provided by the Sponsor or Principal Investigator of the study. Information about the studies is submitted to the Web site (‘‘registered’’) when the studies begin, and is updated throughout the study. In some cases, results of the study or resulting publication citations are submitted to the Web site after the study ends
#34. To: nolu chan (#32)
60 Peer-Reviewed Studies on Medical Marijuana
#35. To: Deckard (#34)
You obviously didn't even look at those two sources.
In its scientific and medical evaluation, DHHS concluded that “research on the medical use of marijuana ha[d] not progressed to the point that marijuana [could] be considered to have a ‘currently accepted medical use’ or a ‘currently accepted medical use with severe restrictions.’” Id. at 40,560. As noted above, DHHS’ recommendations are binding on the DEA insofar as they rest on scientific and medical determinations. 21 U.S.C. § 811(b). After an exhaustive examination of the issue, the DEA, adhering to DHHS’ recommendation, reached the following conclusion:
To establish accepted medical use, the effectiveness of a drug must be established in well-controlled, well-designed, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients (57 FR 10499, 1992). To date, such studies have not been performed. The small clinical trial studies with limited patients and short duration are not sufficient to establish medical utility. Studies of longer duration are needed to fully characterize the drug’s efficacy and safety profile. Scientific reliability must be established in multiple clinical studies. Furthermore, anecdotal reports and isolated case reports are not adequate evidence to support an accepted medical use of marijuana (57 FR 10499, 1992). The evidence from clinical research and reviews of earlier clinical research does not meet this standard.
The DEA interprets “adequate and well-controlled studies” to mean studies similar to what the Food and Drug Administration (“FDA”) requires for a New Drug Application (“NDA”). See id. at 40,562. DHHS found that “there have been no NDA-quality studies that have scientifically assessed the efficacy of marijuana for any medical condition.” Id. It is well understood that, under FDA protocols, “adequate and well-controlled investigations” require “clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” 21 U.S.C. § 355(d). This is a rigorous standard. See, e.g., Edison Pharm. Co. v. FDA, 600 F.2d 831, 843 (D.C. Cir. 1979) (holding that substantial evidence supported the FDA’s conclusion that double-blind testing of a new drug was necessary before the drug could be administered to cardiac patients); Holland-Rantos Co. v. U.S. Dep’t of Health, Educ. and Welfare, 587 F.2d 1173, 1174 (D.C. Cir. 1978) (refusing to construe the requirement of a “well-controlled investigation” in a “self-defeating fashion”).
#38. To: nolu chan (#35)
I don't have to look at your bullshit sources when the sole official source capable of approving the tests, or the drug, states that there has been no test whatsoever that has met the required standards and shown efficacy.
#39. To: goldilucky (#38)
Well, you may choose to not look at Deckard's sources but I just so happened to stumble upon an article written by The Journal of American Medical Association that contradicts what DHHS has to say about cannabis.
Had my mom been prescribing to cannabis rather than the continuous chemo treatments she was getting, she would be still be alive today.
So, I don't put too much faith on most doctors medicine these days.
To establish accepted medical use, the effectiveness of a drug must be established in well-controlled, well-designed, well-conducted, and well-documented scientific studies, including studies performed in a large number of patients (57 FR 10499, 1992). To date, such studies have not been performed.
#41. To: nolu chan (#39)
(Edited)
#45. To: goldilucky (#41)
Are you a real person or a machine?
The DEA’s regulations, which we approved in Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994), define “currently accepted medical use” to require, inter alia, “adequate and well-controlled studies proving efficacy.” Id. at 1135.
Status of Research Into the Medical Uses for Marijuana
''The substance's chemistry must be scientifically established to permit it to be reproduced into dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201 G) of the Food, Drug and Cosmetic Act, 21 U.S.C. 321G), is sufficient to meet this requirement.''
''There must be adequate pharmacological and toxicological studies, done by all methods reasonably applicable, on the basis of which it could fairly and responsibly be concluded, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that the substance is safe for treating a specific, recognized disorder.''
''There must be adequate, well- controlled, well-designed, well-conducted, and well-documented studies, including clinical investigations, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, on the basis of which it could be fairly and responsibly concluded by such experts that the substance will have the intended effect in treating a specific, recognized disorder.''
''The drug has a New Drug Application (NDA) approved by the Food and Drug Administration, pursuant to the Food, Drug and Cosmetic Act, 21 U.S.C. 355. Or, a consensus of the national community of experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, accepts the safety and effectiveness of the substance for use in treating a specific, recognized disorder. A material conflict of opinion among experts precludes a finding of consensus.'' and
''In the absence of NDA approval, information concerning the chemistry, pharmacology, toxicology, and effectiveness of the substance must be reported, published, or otherwise widely available, in sufficient detail to permit experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, to fairly and responsibly conclude the substance is safe and effective for use in treating a specific, recognized disorder.''
Replies to Comment # 45.
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