The administration of oral cannabis extracts is associated with the mitigation of seizures in adolescents with epilepsy, according to clinical data published this month in the journal Epilepsy & Behavior.
Researchers from the Colorado Children’s Hospital in Denver performed a retrospective chart review of 75 children provided cannabis extracts. Authors reported that 57 percent of subjects showed some level of improvement in seizure control while 33 percent reported a greater than 50 percent reduction in seizure frequency.
Researchers also reported “improved behavior/alertness” in one-third of subjects and improved motor skills in ten percent of treated patients. Adverse events were reported in 44 percent of subjects, 13 percent of which reported increased seizure activity. Overall, however, authors concluded that the extracts were “well tolerated by children.”
Separate clinical trial results publicized last week at the 67th Annual Meeting of the American Academy of Neurology reported that the administration of a proprietary form of CBD (cannabidiol) extracts decreased seizure frequency by 54 percent over a 12-week period in children with treatment-resistant epilepsy.
Survey data compiled by Stanford University in 2013 reported that the administration of cannabidiol-enriched cannabis decreased seizures in 16 of 19 patients with pediatric epilepsy.
Last February, the Epilepsy Foundation of America enacted a resolution in support of the “rights of patients and families living with seizures and epilepsy to access physician directed care, including medical marijuana.”
An abstract of the study, “Parental reporting of response to oral cannabis extracts for treatment of refractory epilepsy,” appears online here.
https://medium.com/@MurlocsRock/could-the-grass-be-greener-66b0496925c1
This is the beginning of my story
But we ask our over lords What about the children and they still say Let them die.
I was just laughing about the DEA sex scandal with an electrician when the conversation developed that his beautiful little granddaughter has epilepsy. I told him my nephew has it too. He told me how he has struggled, how he found a wholistic medicine “therapist” who told him about “CBD? Is that right?”
It dawned on me how many of us still live so far behind the cannabis education curve if they don’t get their news from NORML. Too many of us live in fear of arrest or having our families separated and struggle with illness and incarceration and keep getting fed propaganda by syndicated news with prohibitionist underwriters.
I told him to take a trip to Colorado. Visit the University of Colorado, and at Boulder, talk to specialists, and get the appropriate strain. A little thc isn’t going to get your baby high if there is enough anti-psychoactive CBD, but pure CBD oil legally available from Whole Foods might not be the answer either.
The wonderful thing about cannabis is how more than 40 different cannabinoids that work synergistically to treat illness. That doesn’t bode well with pharmaceutical companies that want to patent 1 molecule at a time for profit.
Obama said recently, ” but for those of you thinking that marijuana is going to be panacea, realize there is a commercial industry that is going to exploit that.”
Nice try, Mr. President, but you forgot that one of the side effects from cannabis, a plant from which we cannot overdose, does NOT include death. So what do we have to lose? Or are you worried about what campaign contributions Hillary is about to lose?
(Sigh)
Here we go again;
Causes of Death annually in the U.S. according to the CDC:
Tobacco: 450,000+
Prescription medication: 120,000 and rising
Alcohol: 110,000
Marijuana: (drumroll) 0 …
…as in ZERO deaths in all recorded human history. Even that guy who allegedly ate a marijuana cookie in Colorado and jumped to his death, (no mention of whatever ELSE he was on)…
(From the Book of Mathew):
“Lord, when did we come to thee and see you sick or in prison and feed you or give you clothes?”
And the Lord said,
“Even that which you did for the least of these, my brethren, you did it for me.”
NEW RULE: It is cannabis, cannabis extracts, and cannabis parts until you smoke it. Then it becomes marijuana, which is still not worthy of Schedule 1 status. This year is a good time to call for this revision to the current federal definition of “marihuana” which eliminates its contempt for our Constitution:
The term “marijuana” means all parts of the smoke produced by the combustion of the plant Cannabis sativa L.
What we need is more Contempt for Combustion (heat shock, monoxide and 4221 other malosynergistic toxins)! Tabloid media are/is taking advantage of cannabis controversy to “stock” cannabis-related stories with pictures of Joints (free advertising for wRAPped half-gram-and-bigger Hot Burning Overdose Monoxide format), attracts kids who finding out how much more expensive riefer is and the penalties and so forth, don’t think trying a “regular” $igarette would be that different… ZAP! hooked for life! Young man gets job at $20k a year, spends $4000 a year on pack-a-day habit = 20% nicotine $lavery! Surgeon General 2014 estimate: $289-Bil./yr. US economic cost of “$moking-related illness”.
Part of my brain daydreamed a cartoon of Keith on a double toke with Marc Emery, sharing twin flexdrawtubes of a 25-mg single toke utensil. Keith, at left, stares urgently at viewer (center those eyes intensely) and Emery, at right, holds cheapo Chinese lighter with tip of 1/2-inch-high flame one (1) inch below opening of tilted crater with 25 mg of sifted herb invisibly gettin’ toasted and disvaporated inside.
Swck slow,
don’t glow
till after 19
Seconds or so.
Free the Herb! Free the Green ! Free the Weed!
“Free Green For All; One Marijuana Nation!!!”
If study is not funded by NIDA, it has no credibility? Personal research teaches most of us cause we don’t trust govt programming.
Last week Idaho’s governor Butch Otter vetoed a bill which would have allowed seriously ill Idahoans to use low THC oils. Mr Otter has shown a lack of the kind of progressive leadership that Idaho needs. In his statement Mr Otter quotes recommendations from the state police, and Department of health, and welfare. This underscores a one-sided, dismissive attitude toward Idaho’s marijuana community. I support marijuana legalization in Idaho.
To quote Gov. Otter, “Government should have a limited and well-defined role in citizens’ lives. I am working within that principle to create the conditions in which Idahoans – and Idaho businesses – can thrive. My goal is to empower Idahoans to be the architects of their own destiny.” ‘Unless they want to use or sell marijuana, then I just throw all that out with the bathwater! Welcome to Idaho, we have the cleanest most empowering corruption.’
FDA and Marijuana http://www.fda.gov
Looking for Treatment
The FDA understands that caregivers and patients are looking for treatment options for unmet medical needs. In some instances, patients or their caregivers are turning to marijuana in an attempt to treat conditions such as seizures and chemotherapy-induced nausea.
Untested Drugs can have Unknown Consequences
Over the last few decades, there has been significant interest in the potential utility of marijuana for a variety of medical conditions, including those that already have FDA-approved therapies.
More recently, several states have also passed laws that remove state restrictions on health care professionals using marijuana as a medical treatment for a variety of conditions. A number of other states are considering similar legislation regarding the use of marijuana in medical settings.
FDA’s Role in the Drug Approval Process
The FDA has not approved marijuana as a safe and effective drug for any indication. The agency has, however, approved one drug containing a synthetic version of a substance that is present in the marijuana plant and one other drug containing a synthetic substance that acts similarly to compounds from marijuana but is not present in marijuana. Although the FDA has not approved any drug product containing or derived from botanical marijuana, the FDA is aware that there is considerable interest in its use to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders.
Before conducting testing in humans of a drug that has not been approved by the FDA, an investigator submits an investigational new drug (IND) application, which is reviewed by the FDA. An IND includes protocols describing proposed studies, the qualifications of the investigators who will conduct the clinical studies, and assurances of informed consent and protection of the rights, safety, and welfare of the human subjects. The FDA reviews the IND to ensure that the proposed studies, generally referred to as clinical trials, do not place human subjects at unreasonable risk of harm. The FDA also verifies that there are adequate assurances of informed consent and human subject protection.
The FDA’s role in the regulation of drugs, including marijuana and marijuana-derived products, also includes review of applications to market drugs to determine whether proposed drug products are safe and effective for their intended indications. The FDA’s drug approval process requires that clinical trials be designed and conducted in a way that provide the agency with the necessary scientific data upon which the FDA can make its approval decisions. Without this review, the FDA cannot determine whether a drug product is safe and effective. It also cannot ensure that a drug product meets appropriate quality standards. For certain drugs that have not been approved by the FDA, such as marijuana, the lack of FDA approval and oversight means that the purity and potency of the drug may vary considerably.
As with other drugs that are not approved by the FDA, the agency works closely with the medical and patient communities, and our federal partners when necessary, to allow access to experimental treatments through the expanded access provisions described in the FDA’s statute and regulations. The FDA’s expanded access provisions are designed to facilitate the availability of investigational products to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy available, either because the patients have exhausted treatment with or are intolerant of approved therapies, or when the patients are not eligible for an ongoing clinical trial.
FDA Supports Sound Scientific Research
The FDA also has an important role to play in supporting scientific research into the medical uses of marijuana and its constituents in scientifically valid investigations as part of the agency’s drug review and approval process. As a part of this role, the FDA supports those in the medical research community who intend to study marijuana.
The FDA also supports research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research. Conducting clinical research using marijuana involves interactions with other federal agencies:
The FDA reviews the IND application and the research protocol submitted by the applicant.
The Drug Enforcement Administration (DEA) reviews the registration application filed by the researcher.
The National Institute on Drug Abuse (NIDA) within the National Institutes of Health operates pursuant to the Single Convention on Narcotic Drugs. NIDA has been designated the responsible agency to supply research-grade marijuana to researchers.
State Legislation on Marijuana
Several states have either passed laws that remove state restrictions on the medical use of marijuana and its derivatives or are considering doing so. The FDA supports researchers who conduct adequate and well-controlled clinical trials which may lead to the development of safe and effective marijuana products to treat medical conditions. We have talked to several states, including Florida, Georgia, Louisiana, New York and Pennsylvania, who are considering support for medical research of marijuana and its derivatives to ensure that their plans meet federal requirements and scientific standards.
Related Information
FDA and Marijuana: Questions and Answers
Marijuana Research with Human Subjects
In my opinion;
Legalize Medical Marijuana in Texas, or Not?
I for one am concerned about the lack of public knowledge regarding the truth about medical marijuana. I have completed my Associates Degree in Applied Arts and Sciences, from Lone Star College Montgomery, December 15, 2013. I also earned a Human Services Certificate. I have taken seven Drug and Alcohol classes. (That’s 21 college credit hours). I have done hundreds of hours of research on this issue.
I am not a drug user, I do not drink, and I am a Christian Concretive. I am challenging everyone reading this letter to do their own homework before you make a personal decision as weather or not to legalize medical marijuana. I encourage you to go on the internet to learn that the human body has thousands of cannabis receptor sites. Also the human body has an Endocannabinoid System with in it. Did you know that the most harmful drugs to the human body are legal? Namely; tobacco, alcohol, caffeine, sugar cane are on top of the list. Go on line and find out the facts for each one, and you may be surprised that marijuana is not even on the 25 most harmful to you. There has been propaganda from all kinds of medical professionals who maybe being paid by the big drug companies to make marijuana a bad thing. After doing my own research I cannot trust any more negative data coming from the M.D.A., the F.D.A., and any other credentials behind their name.
I have also been doing research to see if marijuana could be the cure for Cancer. I challenge you to the same. Use your internet search engine, enter, Does marijuana cure Cancer? What an eye opener you will discover. Yes it does, all kinds of cancer. If my doctor tells me that I have cancer again, (I am cancer survivor) I am going to go as fast as I can to Colorado or California to seek out the marijuana cure!
I had a carsoma of the unary bladder duct when I was in my early teens, I was not supposed to live past my 16th birthday. However, my Urologist made up a reddish colored solution that the FDA would not approve because it may have cannabis oil in it. I am very glad that that Urologist used it on me. Along with prayer, God’s Holy Spirit, cured me. Here its 2014, and I’m alive to write this letter.
I encourage you to do your own research on this issue. Let our elected officials in Austin know your findings. Most of our elected officials will take action on feel good legislation and overlook the facts as they pertain to legalizing medical marijuana. Let them know that it’s okay to legalize medical marijuana in Texas.
Al Schlieske
Conroe, TX
1. How is marijuana therapy being used by some members of the medical community?
A. The FDA is aware that marijuana or marijuana-derived products are being used for a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea. To date, the FDA has not approved a marketing application for a drug product containing or derived from botanical marijuana and has not found any such product to be safe and effective for any indication.
2. Why hasn’t the FDA approved marijuana for medical uses?
A. To date, the FDA has not approved a marketing application for marijuana for any indication. The FDA generally evaluates research conducted by manufacturers and other scientific investigators. Our role, as laid out in the Federal Food, Drug, and Cosmetic (FD&C) Act, is to review data submitted to the FDA in an application for approval to assure that the drug product meets the statutory standards for approval.
The FDA has approved Marinol for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol includes the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of marijuana. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.
3. Is marijuana safe for medical use?
A. The FDA has not approved any product containing or derived from botanical marijuana for any indication. This means that the FDA has not found any such product to be safe or effective for the treatment of any disease or condition. Study of marijuana in clinical trial settings is needed to assess the safety and effectiveness of marijuana for medical use.
The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of marijuana.
4. How does FDA’s role differ from NIH and DEA’s role when it comes to the investigation of marijuana for medical use?
A. Conducting clinical research using marijuana involves interactions with several federal agencies. This includes: a registration administered by the Drug Enforcement Administration (DEA); obtaining the marijuana for research from the National Institute on Drug Abuse (NIDA) within the National Institutes of Health; and review of an investigational new drug (IND) application and research protocol by the FDA. Additionally:
• As a Schedule I controlled substance under the Controlled Substances Act, DEA provides researchers with a special registration and has certain requirements at the site marijuana will be studied.
•NIDA provides research-grade marijuana for scientific study. The agency is responsible for overseeing the cultivation of marijuana for medical research and has contracted with the University of Mississippi to grow marijuana for research at a secure facility. Marijuana of varying strengths and potencies is available.
•Researchers work with the FDA and submit an IND application.
5. Does the FDA object to the clinical investigation of marijuana for medical use?
A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from marijuana. The FDA supports the conduct of that research by:
1.Providing information on the process needed to conduct clinical research using marijuana.
2.Providing information on the specific requirements needed to develop a drug that is derived from a plant such as marijuana. In June 2004, the FDA finalized its Guidance for Industry: Botanical Drug Products, which provides sponsors with guidance on submitting IND applications for botanical drug products.
3.Providing specific support for investigators interested in conducting clinical research using marijuana and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
4.Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.
6. What kind of research is the FDA reviewing when it comes to the efficacy of marijuana?
A. The FDA reviews applications to market drug products to determine whether those drug products are safe and effective for their intended indications. The FDA reviews scientific investigations, including adequate and well-controlled clinical trials, as part of the FDA’s drug approval process.
The FDA relies on applicants and scientific investigators to conduct research. Our role, as outlined in the Federal Food, Drug, and Cosmetic Act, is to review data submitted to the FDA in a marketing application to determine whether a proposed drug product meets the statutory standards for approval. Additional information concerning research on the medical use of marijuana is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and NIDA.
7. How can patients get into expanded access program for marijuana for medical use?
A. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations. For example, GW Pharmaceuticalsdisclaimer icon is currently making a drug product that contains cannabidiol and that is being developed for seizure disorders available through expanded access. Information about this program can be obtained from the company.
8. Does the FDA have concerns about administering a cannabis product to children?
A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing marijuana or marijuana constituents, and will continue to work with companies interested in bringing safe, effective, and quality products to market.
9. What is FDA’s reaction to states that are allowing marijuana to be sold for medical uses without the FDA’s approval?
A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of marijuana and its derivatives or are considering doing so. In particular, we know that a number of states are interested in allowing access to cannabinoid oil, or cannabidiol, in an attempt to treat childhood epilepsy. It is important to conduct medical research into the safety and effectiveness of marijuana products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of marijuana and its derivatives to provide information on Federal and scientific standards.
10. What is the FDA’s position on state “Right to Try” bills?
A. The FDA has not taken a position on any particular state “Right to Try” bill. The FDA works with companies to provide patients access to experimental therapies through enrollment in clinical trials or through the expanded access provisions described in the FDA’s statute and regulations. The FDA may permit the use of an experimental therapy, but the sponsor company ultimately decides whether or not to provide experimental therapies to patients.
These channels help to protect patients while also allowing for the collection of data necessary to support the FDA approval of safe and effective therapies for use in the broader population. The FDA is strongly supportive of appropriate use of expanded access protocols and stands ready to work with companies that are interested in providing access to experimental drugs.
11. Has the agency received any adverse event reports associated with marijuana for medical conditions?
A. The agency has received reports of adverse events in patients using marijuana to treat medical conditions. The FDA is currently reviewing those reports and will continue to monitor adverse event reports for any safety signals attributable to marijuana and marijuana products, with a focus on serious adverse effects associated with the use of marijuana.
Information from adverse event reports regarding marijuana use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using marijuana and its constituents can come from clinical trials using marijuana that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of marijuana and its constituents is needed. Clinical trials of marijuana conducted under an IND application could collect this important information as a part of the drug development process.
12. What does the FDA think about making cannabidiol available to children with epilepsy?
A. The FDA understands the interest in making investigational products available to patients while they are being studied for approval, and there are expanded access provisions in both the FDA’s statute and its regulations to make this possible.
13. What should I do if my child eats something containing marijuana?
A. It is important to protect children from accidental ingestion of marijuana and its derivative products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion.
If the parent or caregiver has a reasonable suspicion that the child ingested products containing marijuana, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.
14. I’ve seen marijuana products being marketed for pets. Are they safe?
FDA has recently become aware of some marijuana products being marketed to treat diseases in animals. We want to stress that FDA has not approved marijuana for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products.
15. Can I give my pet marijuana products for medical purposes, such as to relieve the pain of a sick or dying pet?
Marijuana needs to be further studied to assess the safety and effectiveness for medical use in animals. To date, FDA has not approved marijuana for any use in animals. If your pet is in pain, we urge you to talk with your veterinarian about appropriate treatment options.
16. I gave my pet marijuana and I’m concerned my pet is suffering adverse effects. What should I do?
Signs that your pet may be suffering adverse effects from ingesting marijuana may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.
If you have concerns that your pet is suffering adverse effects from ingesting marijuana or any substance containing marijuana, consult your veterinarian, local animal emergency hospital or an animal poison control center immediately.
17. Has the agency received any adverse event reports associated with marijuana for animals?
While the agency is aware of reports of pets consuming various forms of marijuana, to date, FDA has not directly received any adverse event reports associated with giving marijuana to animals via our safety reporting portals. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting marijuana, we encourage you to report the adverse event to the FDA. Please visit here to learn more about how to report an adverse event related to an animal food or drug: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm#Drugs_and_Devices.
18. What is FDA doing about marijuana products currently on the market for pets?
FDA is currently collecting information about marijuana and marijuana-derived products being marketed for animals. FDA reminds consumers that these products have not been evaluated by FDA for safety and effectiveness, and we recommend that you talk with your veterinarian about appropriate treatment options for your pet.
Marijuana Research with Human Subjects
Conducting clinical research using marijuana involves interactions with three federal agencies. This includes: obtaining the marijuana for research from the National Institute on Drug Abuse (NIDA) within the National Institutes of Health; review of an investigational new drug (IND) application and the research protocol by the Food and Drug Administration (FDA) and an investigator registration and site licensure by the Drug Enforcement Administration (DEA). Specifically:
•National Institute on Drug Abuse (NIDA) to obtain the marijuana for research. One important source of research-grade marijuana for scientific study is through the NIDA drug supply program. The marijuana supply program operates pursuant to the Single Convention on Narcotic Drugs disclaimer icon, which imposes certain obligations related to governmental oversight of marijuana cultivation. In the United States, NIDA has been designated the agency responsible for overseeing the cultivation of marijuana for medicinal research. NIDA contracts with the University of Mississippi to grow marijuana for use in research studies. The University designates a secure plot of land where marijuana crops are grown, harvested, and stored. The marijuana is made into cigarettes or other purified elements of marijuana to use for research. Investigational marijuana products with varying strengths or potencies are available.
•Food and Drug Administration (FDA) to submit an investigational new drug (IND) application. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as marijuana, researchers need to work with the FDA and submit an IND application. The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. Specifically, the Guidance for Industry: Botanical Drug Products provides sponsors with guidance on submitting investigational INDs for botanical drug products.
•Drug Enforcement Administration (DEA) to obtain investigator registration and site licensure to conduct studies using marijuana. As a Schedule I controlled substance under the Controlled Substances Act (CSA), marijuana use in a clinical trial requires special licensure and registration requirements for the investigator and the site where the study will be conducted. For more information, see CFR §1301.18 DEA, Research Protocols.
Typical Process for Conducting Research with Marijuana
Step 1: Sponsor obtains pre-IND number from FDA.
Step 2: Sponsor contacts NIDA to obtain information on the specific strains of marijuana available, so that information can be included in the IND application.
Step 3: Sponsor contacts DEA for registration application and Schedule 1 license.
Step 4: Sponsor receives Letter of Authorization (LOA) from NIDA.
Step 5: Sponsor sends copy of IND/protocol and LOA to FDA and DEA.
Step 6: FDA reviews the IND.
Step 7: Sponsor contacts NIDA to obtain the marijuana after the FDA completes its review of the IND, and the DEA registration is received.
Additional Resources
•Development & Approval Process (Drugs)
•FDA Center for Drug Evaluation and Research Small Business and Industry Assistance group
•National Institutes of Health (NIH): Guidance on Procedures for Provision of Marijuana for Medical Research
•National Institute on Drug Abuse’s (NIDA) Role in Providing Marijuana for Research
•Drug Enforcement Administraton – Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
•International Narcotics Control Board: Single Convention on Narcotic Drugs (1961)See Disclaimer page regarding links to external sites
•National Institute on Drug Abuse (NIDA): Ordering Guidelines for Marijuana and Marijuana Cigarettes
Related Information
•FDA and Marijuana
•FDA and Marijuana: Questions and Answers