As research and anecdotal evidence increasingly indicate cannabis has medical benefits, a new series of videos from a man suffering from Parkinsons 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 Parkinsons disease while providing insights into the tangible benefits of an active lifestyle, particularly through recumbent cycling, according to the films Facebook page.
More recently, Larry began to experiment with medical marijuana to treat his worsening symptoms. In a video uploaded to Ride with Larrys 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.
Larrys at the point where hes 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 cant 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 Larrys 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 Parkinsons disease who gives him cannabis oil to place under his tongue. His relief is almost instantaneous. According to the videos description:
With a few drops of cannabis oil under his tongue, Larrys severe dyskinesia (uncontrolled movements), loss of voice, and tremors are calmed within in minutes! We didnt 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 youve 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 Parkinsons 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 cant get it in my home state.
At least one academic expert shares this frustration.
As Dr. Daniele Piomelli, a professor of Pharmacology at UC Irvines medical school, says in Part 3 of Larrys 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 Parkinsons 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 Parkinsons disease. From animal experiments, we also know that boosting certain branches of the endocannabinoid system is helpful in relieving symptoms of Parkinsons. 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 Parkinsons. 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 plants effectiveness, Larrys experience may provide hope to countless others suffering from debilitating ailments (Part 3 has been viewed over 20 million times as of this articles 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 its permissible, Im still uncomfortable. But, you know, if this is the only thing and as far as I know weve tried everything, and this is the only thing thats 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 its not available to us.
Still, as stories like Larrys 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.
Marijuana should never be thought of as a replacement for dopaminergic and other approved therapies for Parkinson's disease. -- Dr. Michael S. Okun, National Medical Director, National Parkinson Foundation
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?
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.
marijuana has no currently accepted medical use because: As detailed in the HHS evaluation, the drugs chemistry is not known and reproducible; there are no adequate safety studies;
there are no adequate and well-controlled studies proving efficacy
81 Fed Reg No 156 (12 Aug 2016) 53767-53845, Proposed Rules Denial, Docket DEA-427
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
(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.
You obviously didn't even look at those two sources.
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:
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 drugs 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.
At 26-28:
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 FDAs 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. Dept 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).
Contrary to what Petitioners suggest, something more than peer-reviewed studies is required to satisfy DEAs 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 peerreviewed 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 [agencys] 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 DEAs construction of its regulation is eminently reasonable. Therefore, we are obliged to defer to the agencys interpretation of adequate and well-controlled studies. See Thomas Jefferson Univ., 512 U.S. at 512 (deferring to an agencys interpretation of its own regulations). Judged against the DEAs 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 marijuanas 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 marijuanas 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.
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.
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.
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.
I'm sorry for your loss. Unfortunately some of the posters on this thread would much rather see someone suffer and die rather than to allow them access to cannabis.
I wonder how many would let their own children or parents suffer if cannabis was the only substance that could promise relief from pain or seizures?
Unfortunately some of the posters on this thread would much rather see someone suffer and die rather than to allow them access to cannabis.
That is an irresponsible vindictive claim where you show malicious ill will and a desire to hurt motivated entirely by spite and ignorance. You have no evidence to support your allegation, a allegation that is completely false in that there have been no events such as that you allege.
That is an irresponsible vindictive claim where you show malicious ill will and a desire to hurt motivated entirely by spite and ignorance. You have no evidence to support your allegation, a allegation that is completely false in that there have been no events such as that you allege.
No that is not true. The DHHS is not in the business of practicing medicine and therefore they are not the experts in making such determinations about cannabis. Let the doctors in the research and development do their job.
There has been research done on the medicinal purposes of this herb. Furthermore, cannabis has already been included in many medicines doctors prescribe however it is not as effective because it has been mixed with other FDA medicines making it less effective. If the patients were administered just the raw dosage of cannabis, they would get results more promising than just a mixture compressed with other drug elements. The reason why cannabis has been mixed with other drug elements is so that the cannabis loses its true purpose of healing and this is good for the doctors and hospital administrations as they making a huge profit. Were cannabis to be administered in raw form and under close supervision, there would be positive results and it would put the hospitals out of business. Hospitals and doctors are not in the business of healing people. Your illness is their opportunity to staying in business. You are nothing to them but a walking paycheck everytime you need their services which is why the first thing they prey on is your health insurance policies because if you don't have enough to cover those outrageous hospital and medical expenses, they will take your home.
The DHHS is not in the business of practicing medicine and therefore they are not the experts in making such determinations about cannabis. Let the doctors in the research and development do their job.
This is absolute bullshit and directly contrary to Federal statute law.
DHHS is emphatically assigned the authority and responsibility for the scientific and medical evaluation, and the DHHS recommendation is binding on the Attorney General per 21 U.S.C. § 811.
The binding scientific and medical recommendation of DHHS holds that all of your blather about marijuana studies fails to have met the required medical and scientific standards. In addition, due to treaty obligations, marijuana cannot be assigned to less than Schedule 2.
DEA Dockets 426 and 427 Responses of 12 August 2016 - requests to reschedule Marjuana DENIED
These are the actual DEA responses of 12 August 2016 to requests to Reschedule Marijuana, DEA Dockets 426 and 427, as taken from the Federal Register.
81 Fed Reg No 156 (12 Aug 2016) 53767-53845, Proposed Rules Denial, Docket DEA-427
You requested that DEA remove marijuana from schedule I based on your assertion that:
1. Marijuana has accepted medical use in the United States;
2. Studies have shown that smoked marijuana has proven safety and efficacy;
3. Marijuana is safe for use under medical supervision; and
4. Marijuana does not have the abuse potential for placement in schedule I
In accordance with the CSA scheduling provisions, after gathering the necessary data, DEA requested a scientific and medical evaluation and scheduling recommendation from the Department of Health and Human Services (HHS). HHS concluded that marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision. Therefore, HHS recommended that marijuana remain in schedule I. The scientific and medical evaluation and scheduling recommendation that HHS submitted to DEA is attached hereto.
Based on the HHS evaluation and all other relevant data, DEA has concluded that there is no substantial evidence that marijuana should be removed from schedule I. A document prepared by DEA addressing these materials in detail also is attached hereto. In short, marijuana continues to meet the criteria for schedule I control under the CSA because:
(1) Marijuana has a high potential for abuse. The HHS evaluation and the additional data gathered by DEA show that marijuana has a high potential for abuse.
(2) Marijuana has no currently accepted medical use in treatment in the United States. Based on the established five-part test for making such determination, marijuana has no currently accepted medical use because: As detailed in the HHS evaluation, the drugs chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and wellcontrolled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.
(3) Marijuana lacks accepted safety for use under medical supervision. At present, there are no U.S. Food and Drug Administration (FDA)-approved marijuana products, nor is marijuana under a New Drug Application (NDA) evaluation at the FDA for any indication. The HHS evaluation states that marijuana does not have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in wellcontrolled clinical trials that scientifically evaluate safety and efficacy.
The statutory mandate of 21 U.S.C. 812(b) is dispositive. Congress established only one schedule, schedule I, for drugs of abuse with no currently accepted medical use in treatment in the United States and lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b).
Although the HHS evaluation and all other relevant data lead to the conclusion that marijuana must remain in schedule I, it should also be noted that, in view of United States obligations under international drug control treaties, marijuana cannot be placed in a schedule less restrictive than schedule II. This is explained in detail in the accompanying document titled Preliminary Note Regarding Treaty Considerations.
Accordingly, and as set forth in detail in the accompanying HHS and DEA documents, there is no statutory basis under the CSA for DEA to grant your petition to initiate rulemaking proceedings to reschedule marijuana. Your petition is, therefore, hereby denied.
Sincerely,
Chuck Rosenberg, Acting Administrator
Attachments:
Preliminary Note Regarding Treaty Considerations
Cover Letter from HHS to DEA Summarizing the Scientific and Medical Evaluation and Scheduling Recommendation for Marijuana.
U.S. Department of Health and Human Services (HHS)Basis for the Recommendation for Maintaining Marijuana in Schedule I of the Controlled Substances Act
U.S. Department of JusticeDrug Enforcement Administration (DEA), Schedule of Controlled Substances: Maintaining Marijuana in Schedule I of the Controlled Substances Act, Background, Data, and Analysis: Eight Factors Determinative of Control and Findings Pursuant to 21 U.S.C. 812(b)
Chapter 13 - Drug Abuse Prevention and Control (Sections 801 - 971)
Subchapter I - Control and Enforcement (Sections 801 - 904)
Part B - Authority to Control; Standards and Schedules (Sections 811 - 814) Sec. 811 - Authority and criteria for classification of substances
21 U.S.C. § 811 (2014)
§811. Authority and criteria for classification of substances
(a) Rules and regulations of Attorney General; hearing
The Attorney General shall apply the provisions of this subchapter to the controlled substances listed in the schedules established by section 812 of this title and to any other drug or other substance added to such schedules under this subchapter. Except as provided in subsections (d) and (e) of this section, the Attorney General may by rule
(1) add to such a schedule or transfer between such schedules any drug or other substance if he
(A) finds that such drug or other substance has a potential for abuse, and
(B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed; or
(2) remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.
Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of chapter 5 of title 5. Proceedings for the issuance, amendment, or repeal of such rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary, or (3) on the petition of any interested party.
(b) Evaluation of drugs and other substances
The Attorney General shall, before initiating proceedings under subsection (a) of this section to control a drug or other substance or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance. In making such evaluation and recommendations, the Secretary shall consider the factors listed in paragraphs (2), (3), (6), (7), and (8) of subsection (c) of this section and any scientific or medical considerations involved in paragraphs (1), (4), and (5) of such subsection. The recommendations of the Secretary shall include recommendations with respect to the appropriate schedule, if any, under which such drug or other substance should be listed. The evaluation and the recommendations of the Secretary shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the Secretary to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance. If the Attorney General determines that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or substantial evidence that the drug or other substance should be removed entirely from the schedules, he shall initiate proceedings for control or removal, as the case may be, under subsection (a) of this section.
(c) Factors determinative of control or removal from schedules
In making any finding under subsection (a) of this section or under subsection (b) of section 812 of this title, the Attorney General shall consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the schedules:
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter. (d) International treaties, conventions, and protocols requiring control; procedures respecting changes in drug schedules of Convention on Psychotropic Substances
(1) If control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by subsection (a) of this section or section 812(b) of this title and without regard to the procedures prescribed by subsections (a) and (b) of this section.
You say my post was bullshit. I refer you to post #72 because that is a federal statute and is still in the books today. You choose to argue the differences of facts.