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Fda Approves New Ptsd Study With Medical Marijuana


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Research..Research..Research...To allow law enforcement (DEA) to block scientific studies that could prove beneficial to hundreds of millions of people around the world is against everything America stands for.

 

The greatest discovery of my generation is that man can alter his life simply by altering his attitude of mind.

- William James

 

FDA Approves New PTSD Study with Medical Marijuana

 

http://santacruz.patch.com/articles/fda-approves-new-ptsd-study-with-medical-marijuana

 

Several months ago, I reported on how the Santa Cruz Multidisciplinary Association for Psychedelic Studies (MAPS) was beginning the first experimental sessions in their second MDMA study on posttraumatic stress disorder (PTSD).

 

PTSD is an extremely difficult medical condition to treat, and it currently effects around 7.8 percent of Americans. It is caused by exposure to dangerous and highly stressful situations, which can result in lasting symptoms that include disturbing flashbacks, distressful emotions, panic attacks, and nightmares.

 

On April 28th the U.S. Food and Drug Administration (FDA) accepted MAPS' protocol design for their study of cannabis as a treatment for symptoms of PTSD in war veterans. This approval from the FDA represents another important step forward in PTSD research, although there is still a major hurdle to overcome before the research can actually begin. The FDA stated that MAPS’ current protocol successfully addresses all of their concerns, as long as the researchers can obtain cannabis for the study.

 

Living here in Santa Cruz, with medical cannabis dispensaries popping up like fast food restaurants, you’d think that access to marijuana would be the easy part. However, there is only one place to egally obtain cannabis for a medical study in the U.S.--from the government itself, which has had an unconstitutional monopoly on the plant for research purposes since 1968. So, in order to obtain cannabis for the PTSD study, yet another government review process needs to take place.

 

The National Institute on Drug Abuse/Public Health Service (NIDA/PHS) also has to approve the cannabis/PTSD study before it can begin. Although the FDA has repeatedly demonstrated its willingness to evaluate studies on the basis of scientific merit, NIDA/PHS appears to continually position politics over science, and has consequently blocked medical marijuana studies from moving forward.

 

“This redundant review, which may take another year or more, is required solely because NIDA has a monopoly on the supply of marijuana for research. NIDA/PHS must review and accept the protocol before allowing us to purchase marijuana from NIDA. This process is biased from the start, since NIDA’s mission does not include exploring the potential beneficial uses of marijuana,” said MAPS Director of Communications Brad Burge.

 

MAPS has been trying for years to continue their medical marijuana vaporizer research, and although the FDA has approved that next study as well, the DEA has prevented them from conducting it by not allowing the researchers to obtain the necessary cannabis. (For more information about this, see the in-depth article that I wrote for High Times on the subject: www.maps.org/media/view/crop_blockers/) There is concern that this could happen again with the PTSD study that was just approved by the FDA.

 

According to Burge, many U.S. veterans already use medical marijuana to deal with their symptoms of PTSD. “MAPS is seeking to conduct the first clinical trial testing the use of the smoked or vaporized marijuana plant in PTSD patients. Now PHS/NIDA will decide if MAPS can obtain marijuana for 50 suffering veterans,” said Burge.

 

To find out more about MAPS, or to make a contribution to help further medical cannabis and psychedelic drug therapy research, see: www.maps.org

 

I recently edited the annual MAPS theme bulletin, which was dedicated to psychedelics and the mind/body connection. The online edition is available here:

 

www.maps.org/media/bulletin/special_edition_psychedelics_the_mind_body_connection/

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I have PTSD, numerous causes... it is a real burden and the help marijuana provides is real. This is great news!

 

Another reason we have to fight for the Qualifying Conditions Review Panel be seated. The states refusal to fully implement the MMMA of 2008 fully demonstrates their incompetence to hold the positions of office they have.

 

Rule 333.131 Review panel for reviewing petitions for additional medical

conditions or treatments.

Rule 31.

 

(1) The department shall appoint a panel of not more than 15

members to review petitions to add medical conditions or treatments to the

list of debilitating medical conditions under R 333.101 (5). A majority of

the panel members shall be licensed physicians, and the panel shall provide

recommendations to the department regarding whether the petitions should be

approved or denied.

 

(2) Members of the review panel shall include, but not be limited to, the

Michigan chief medical executive and 7 appointed members of the advisory

committee on pain and symptom management as described in MCL 333.16204a. The

7 review panel members from the advisory committee on pain and symptom

management shall include 4 licensed physicians and 3 non-physicians.

 

(3) The department shall provide staff support to the review panel to

assist with the scheduling of meetings, conference calls, dissemination of

petition-related materials, and to perform other administrative duties

related to the performance of the panel’s review.

 

(4) A quorum of the review panel shall concur with the recommendation in

order to be considered an official recommendation of the panel. For the

purposes of this subrule, a majority of the members appointed and serving on

the review panel constitutes a quorum.

 

History: 2009 AACS.

 

Rule 333.133 Petition to add qualifying diseases or medical conditions;

review panel; recommendations.

Rule 33.

 

(1) The department shall accept a written petition from any

person requesting that a particular medical condition or treatment be

included in the list of debilitating medical conditions under R 333.101.

 

(2) The department shall submit the written petition to the review panel.

Within 60 days of receipt of the petition, the panel shall make a

recommendation to the department regarding approval or denial of the petition.

 

(3) Upon receipt of a recommendation from the review panel, the department

shall do all of the following:

 

(a) Post the panel’s recommendations on the department’s website for

public comment for a period of 60 days.

(b) Give notice of a public hearing not less than 10 days before the date

of the hearing.

© Hold a public hearing within the 60-day time period that the

recommendation from the panel is posted on the department’s website.

 

(4) After a public hearing, the department shall forward comments made

during the hearing to the panel for review. If, based on a review of the

comments, the panel determines that substantive changes should be made to its

initial recommendation, the petition shall be denied, the department shall

provide the petitioner with a copy of the initial recommendation and an

explanation of the substantive changes, and the petitioner may resubmit the

petition to the department at any time. If no changes are made to the

initial recommendation or the changes are minor and do not affect the general

content of the recommendation, the department shall forward the

recommendation to the department director for a final determination on the

petition.

 

(5) Within 180 days of the date the petition is filed with the department,

the department director shall make a final determination on the petition. The

approval or denial of the petition shall be considered a final department

action subject to judicial review under the act.

 

(6) If the petition is approved, the department shall create a document

verifying the addition of the new medical condition or treatment to the list

of debilitating medical conditions identified under R 333.101. Until such

time as these rules are amended to officially recognize the medical condition

as a qualifying debilitating medical condition, the department shall develop

a policy that allows the new medical condition to be used as a qualifier for

a registry identification card.

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Yes, that really needs to be done. Long overdue. Many of those with PTSD are going to have physical ailments involving chronic pain (veterans) and can get med mj regardless, but they should be able to be honest with their doctor, if marijuana is helping them with their PTSD.

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