United States Patent 6630507B1
Original application began in 1998 , granted to the U.S. Department of Health and Human Services 10/7/2003.
Cannabinoids as antioxidants and neuroprotectants
Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new found property makes cannabinoids useful in the treatment and prophylaxis of a wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and HIV dementia. Non Psychoactive cannabinoids, such as cannabidiol, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention. A particular disclosed class of cannabinoids useful as neuroprotective antioxidants is formula (I) wherein the R group is independently selected from the group consisting of H, CH3, and COCH3.
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What NIDA (National Institute for Drug Abuse ) says...
What is medical marijuana?
The term medical marijuana refers to using the whole, unprocessed marijuana plant or its basic extracts to treat symptoms of illness and other conditions. The U.S. Food and Drug Administration (FDA) has not recognized or approved the marijuana plant as medicine.
However, scientific study of the chemicals in marijuana, called cannabinoids, has led to two FDA-approved medications that contain cannabinoid chemicals in pill form. Continued research may lead to more medications.
Because the marijuana plant contains chemicals that may help treat a range of illnesses and symptoms, many people argue that it should be legal for medical purposes. In fact, a growing number of states have legalized marijuana for medical use.
Why isn’t the marijuana plant an FDA-approved medicine?
The FDA requires carefully conducted studies (clinical trials) in hundreds to thousands of human subjects to determine the benefits and risks of a possible medication. So far, researchers haven't conducted enough large-scale clinical trials that show that the benefits of the marijuana plant (as opposed to its cannabinoid ingredients) outweigh its risks in patients it's meant to treat.
(reminder , that is NIDA explaining why the FDA hasn't approved cannabis for medicine to date. A vague explanation that excludes the fact that cannabis still remains a schedule 1 controlled substance meaning the ONLY federally recognized research and cannabis come from NIDA! The National Institute for Drug Abuse! A Federal institute that does not approve studies for the medical potential or value of “drugs”. Including plants that are scheduled as drugs)
What the DEA say - Dea.gov...
Much like our partners at the Department of Health and Human Services (HHS), the Department and DEA fully support research into the effects of marihuana and the potential medical utility of its chemical constituents. In the last few years, the Department and DEA, in close collaboration with HHS and the Office of National Drug Control Policy (ONDCP), have made great strides in improving research with marijuana and its constituent parts.
As detailed below, to further expand medical and scientific research, the Department and DEA are taking a number of actions to increase the number of registered marijuana manufacturers (or growers), consistent with applicable law, to meet a demonstrated need for different varieties.
(Testimony goes on to say that Marijuana was placed on schedule 1 by Congress in 1970.)
DEA is committed, consistent with the CSA, to assisting the health care needs of patients and supporting research involving marijuana. DEA shares the view that medical decisions should be based on science and adherence to the established drug approval process which ensures that only safe and effective drugs are approved to be available in the United States. DEA continues to make the approval of schedule I researchers a top priority and we look forward to continuing our efforts with our interagency partners to expand research efforts for all controlled substances, including marijuana. (Reminder, the “interagency partners” are waiting on and rely on the DEA, masters of the controlled substance list who have cannabis classified as a schedule 1)!
Most recently, in 2016, the US Drug Enforcement Administration rejected a pair of administrative petitions that sought to initiate rule-making proceedings to reschedule marijuana under federal law. The agency opined, “[T]here is no substantial evidence that marijuana should be removed from Schedule I.”
To the contrary, there exists ample scientific and empirical evidence to rebut the federal government’s contention. Despite the nearly century-long prohibition of the plant, cannabis is nonetheless one of the most investigated therapeutically active substances in history. To date, there are more than 26,000 published studies or reviews in the scientific literature referencing the cannabis plant and its cannabinoids, according to a keyword search on the search engine PubMed Central, the US government repository for peer-reviewed scientific research, with over 1,000 new studies published annually. While much of the renewed interest in cannabinoid therapeutics is a result of the discovery of the endocannabinoid regulatory system (which is described in detail later in this publication), much of this increased attention is also due to the growing body of testimonials from medical cannabis patients and their physicians, as well as from state-level changes to the plant’s legal status.
The scientific conclusions of the majority of modern research directly conflicts with the federal government’s stance that cannabis is a highly dangerous substance worthy of absolute criminalization. For example, a summary of FDA-approved randomized clinical trials evaluating the safety and efficacy of whole-plant cannabis in various patient populations finds: “Evidence is accumulating that cannabinoids may be useful medicine for certain indications. … The classification of marijuana as a Schedule I drug as well as the continuing controversy as to whether or not cannabis is of medical value are obstacles to medical progress in this area. Based on evidence currently available the Schedule I classification is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.”
More recently, a 2017 review of over 10,000 recent studies by the National Academies of Sciences, Engineering, and Medicine concluded that “conclusive or substantial evidence” exists in support of the clinical use of cannabis for the treatment of chronic pain and other conditions.
To date, over 140 gold-standard clinical trials exist examining the safety and efficacy of cannabis or individual cannabinoids in some 8,000 patients. By contrast, many FDA-approved drugs are subject to far fewer clinical trials involving far fewer subjects prior to market approval. In fact, according to a 2014 review paper published in the Journal of the American Medical Association, the median number of pivotal trials performed prior to FDA drug approval is two, and over one-third of newly approved pharmaceuticals are brought to market on the basis of only a single pivotal trial.