FDA asking for your comments on Cannabis International scheduling

Any rational evaluation of cannabis would dictate that should it be removed from the drug schedule. Now it appears that the Food and Drug Agency (FDA) is slowly starting to recognize the fallacy of cannabis (AKA Marijuana) being classified as a schedule 1 drug (definition of Schedule 1 is at the end of this article).

The FDA has now reopened the comment period on "International Drug Scheduling for Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis." Please take the time to take this additional time to submit comments to the FDA.

For more details and additional instructions see
https://www.regulations.gov/document?D=FDA_FRDOC_0001-9485
To comment please use the link below, note all comments are due Sep 30 2019, at 11:59 PM ET
https://www.regulations.gov/comment?D=FDA_FRDOC_0001-9485

All submissions received must include the Docket No. FDA-2019-N-0767 for “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis.”

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The exact schedule 1 drug definition for marijuana per United States Law 21 U.S.C. ch. 13 § 801 signed by President Nixon in 1971 is listed below. Note Statements 1, 2, 3 are “LOGIC AND” legal statements.

1. There is a lack of accepted safety for use of the drug or other substance under medical supervision.
2. The drug or other substance has a high potential for abuse.
3. The drug or other substance has no currently accepted medical use in treatment in the United States.

Medical Marijuana Patients Ongoing Items of Concern

With the Ohio Medical Marijuana Program halfway operational, we are coming into a different phase and OPN plans on making positive changes. Below is a list of issues that need correction, the biggest issue is the extreme CO$T of MMJ here in Ohio.  These items listed below are in addition to submitting once again a petition once again with a lot more Physicians support for opiate addiction along with a petition for Migraines. We will be working on the legislature and the various boards for their support.

Card Holding Patients

Given that there are approximately 57,589 Medical Marijuana patients so far in Ohio.  There are a number of serious concerns.

 

• Foremost is the excessive cost due to extraordinary high fees on the various business operations.  This is directly reflected in the low number of purchases that have to date.
• Second is the erroneous assumptions physicians make when a patient tests positive for marijuana resulting in the removal from pain clinics and/or other drug prescriptions.
• The extremely slow process of the program becoming operational has caused patients to lose faith in the Ohio government's commitment to making this program a success.
• The lack of reciprocity with other states, in particular with Michigan, Pennsylvania, and West Virginia is lacking and needs to be authorized.
• Law enforcement needs training for interacting with card holding patients with marijuana or marijuana from an out of state source?

 

Caregivers & Patients

Given that patients are required to have a face to face in-person visit with a physician to obtain a recommendation.

• Bedridden patients have a very difficult time to obtain a Medical Marijuana Recommendation. OPN recommends a change in the law to the State Legislature regarding Doctor's in-person only visit. There are homebound patients that cannot physically get to a remote doctor for a recommendation.
• OPN recommends a temporary emergency rule change to the Ohio Medical Board covering this situation.

 

Patients & Driving

Given the status of OVI laws and the legislation passed by HB523 and that no patients would pass the legal limit for driving an automobile.

• OPN suggests changes to the State Legislature to the OVI laws regarding marijuana.
• Note OPN personnel have provided legislative testimony and information regarding marijuana driving issues before HB523, as well as instructing the Mayors of Ohio regarding the truth about Marijuana and driving in an official Ohio Municipal League training course.

 

Medical Licenses

Given a recent warning notice regarding those holding state issue licenses for medical care and the handling of medical marijuana products and that hospice nurse are explicitly permitted to be caregivers note the following.

• Hospice nurses' licenses are not protected while caring for patients. OPN recommends a change to the State Legislature to protect nursing licenses when acting as a caregiver.
• OPN recommends the state legislature that all licensed physicians and nurse practitioners with an Ohio license to prescribe may issue Medical Marijuana recommendations.

Medical Board of Ohio playing fast and loose with the MMJ Petition process

 

The Medical Board of Ohio has been playing fast and loose with the 2018 Petition process as demonstrated in their last meeting regarding the Autism petition. As a result, OPN has submitted a Public Record request as follows.

.-.-.-.-.-.-.-.Public Record request -.-.-.-.-.

The State Medical Board of Ohio Meeting Minutes for June 12, 2019, states that on, “On May 8, the Board’s Medical Marijuana Expert Review Committee completed its review of the expert reports.”

Per Ohio’s Ohio Open Records I request a list of the members of the Medical Marijuana Expert Review Committee who reviewed the expert reports regarding the petitions to add qualifying conditions to the Ohio Medical Marijuana Control Program.

I also request all written reports and minutes compiled by the Medical Marijuana Expert Review Committee who reviewed the expert reports regarding the petitions to adding a qualifying condition to the Ohio Medical Marijuana Control Program.

Note OPN has a copy of the Experts Reports from an earlier Information request. The title of the PDF file is “Combined Subject Matter Expert Reports” with a creation date May 16th, 2019 that contain Drs Zaraa, Woyshville, and Parran reports on the Opioid Addiction/Opioid Use Disorder Anxiety Disorder, Insomnia, Depression, and Autism Spectrum Disorder.

Letter to the Ohio Medical Board to add Opiate Addiction to the Medical Marijuana Program

On June 12^th, the Ohio Medical Board will be deciding to approve or not opiate addiction to the Ohio Medical Marijuana Control Program (HB523).  The expert panel reviewing the addiction petitions were sent to Dr. Woyshville, who was supportive; and Dr. Parran, who was not, to add opiate addiction to the qualifying condition list.   Below was part of an email request to the Board to support adding opiate addiction to the Medical Marijuana Control program.

 

Below are some key reasons why Ohio Patients authored the petition and supports adding this condition.

1. There are numerous findings that show the decrease in overdoses in states with marijuana laws.
2. There are numerous studies that show the decrease in opiates pills being prescribed in states with marijuana laws.
3. Marijuana is effective for those addicted to manage the withdrawal negative effects, which is a huge deterrent to seeking out and staying in addiction treatment.
4. Studies have shown an increase in the duration of being enrolled in treatment for those using marijuana. This is a key factor in being successful in overcoming addiction.
5. Recently New Jersey, Pennsylvania, and Illinois, after their own medical reviews, have added included opiate addiction to their programs.
6. Just recently a well document study that refuted Dr. Parran’s reason to reject the petition. The report title is “Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial by Yasmin L. Hurd, et al.
7. Drugs such as Suboxone have their own addiction potential.

Simply stated addiction is a very difficult disease to treat with very limited positive results and typically has multifaceted reasons for the condition to exist. The medical use of Marijuana is just another tool in a doctor’s toolbox that is inherently safe for the patient. We do not subscribe to the thought, of just taking marijuana to cure a person of this condition, we highly recommend that its use is as a part of the overall treatment plan.

 

Here is a Link to the experts' reports to Ohio Medical Board with page numbers for the two doctors' opposite opinions.

https://www.med.ohio.gov/Portals/0/For%20The%20Public/Combined%20Subject%20Matter%20Expert%20Reports.pdf

SUBJECT MATTER EXPERT REPORT: OPIOID USE DISORDER

a.  See Expert Opinion by Mark J. Woyshville MD, starting at Page 28 of 206

b.  See Expert Opinion by Ted Parran, MD, starting at page 73 of 206

 

Also included is a link to our original petition below. Please feel to contact us for further discussion on this matter if warranted. Note section 4 contains a large collection of references to why opiate addiction should be added in our opinion.

http://www.ohiopatientsnetwork.org/index.php/25-medical/119-petition-to-ohio-medical-board-to-add-opiate-addiction-to-ohio-s-list-of-conditions-for-medical-marijuana