The difficulty in treating PTSD is reflected in the variety of treatment modalities and prescription medications that have been used in attempts to reduce the severity of this condition. Individual psychotherapy, Cognitive Behavioral Therapy, Eye Movement Desensitization and Reprocessing, and Group Therapy are among the non-medical treatments that have been tried with limited success. Anti-depressants, sedatives, and anti-psychotic medications have also been employed with limited benefit and serious side effects. Currently the U.S. FDA has approved two anti-depressants for the treatment of PTSD. These are Zoloft and Paxil, both of which have limited efficacy and produce remission in only about one-quarter of patients. Such medications have also been found to double the risk of suicidal thinking and suicidal attempts in patients 24 years or less, which pertains to a large percentage of our returning young veterans.

Clearly, safer and more effective treatments are needed. PTSD not only results in an array of debilitating symptoms, but it also causes specific changes to certain areas of the brain that are responsible for the processing malfunctions that underlie this disease. Activation of the primitive mammalian brain, or limbic system, during times of severe stress may play a role in optimizing survival. However, when this center of the brain becomes hyper-active and over-stimulated as a result of misguided neuro-plasticity, direct intervention at the cellular level is required.

The key to using Cannabis to treat PTSD lies in the distribution of naturally occurring Cannabinoid receptors in those areas of the brain that cause the symptoms associated with PTSD. The presence of CB1 receptors in the hippocampus, amygdala, prefrontal cortex and anterior cingulate cortex supports the conclusion that Cannabinoids are involved in regulating anxiety, response to stressful situations, and the extinction of conditioned fear. This conclusion is also supported by pre-clinical research showing that mice without CB1 receptors, or mice whose CB1 receptors have been rendered non-functional by chemical blockade, exhibit increased levels of anxious behavior and loss of the ability to extinguish previously learned fearful behaviors. Conversely, the stimulation of CB1 receptors in the amygdala of rats has been shown to protect against the effects of stress on fear conditioning and avoidance behavior.

Early human studies using synthetic Cannabinoids have also shown that stimulation of the endogenous Cannabinoid system is significantly effective in reducing the occurrence of treatment-resistant nightmares in PTSD patients, along with subjective improvements in sleep time and sleep quality, and a reduction in daytime flashbacks. These results stand in stark contrast to a recent study sponsored by the Veterans Administration National Center for PTSD, which showed that treatment with a second-generation anti-psychotic medication was ineffective at controlling symptoms in combat related PTSD patients.

Fortunately, there is something that the State of Hawaii can do to improve the treatment options that are available to our stricken veterans. A new bill, SB 2406, was recently introduced into the Senate, which would add PTSD as a qualifying medical condition under Hawaii鈥檚 Medical Marijuana Program. Such an addition would make it possible for registered physicians to recommend Cannabis to their PTSD patients for personal use under medical supervision. New Mexico, California and Delaware already allow PTSD patients to utilize Medical Cannabis, and it is likely that others will also follow suit as more states recognize the benefit that this herbal botanical substance can bring.

But nothing is going to happen unless we make it. Those of us who recognize the benefit of using Cannabis to treat PTSD need to make our voices heard in the Hawaii Legislature. This is especially true in the House of Representatives, where certain committees have shown little willingness to make improvements in Hawaii鈥檚 Medical Marijuana Program. It is time to put the 鈥淲e鈥� back in 鈥淲e the People鈥�, by contacting the Committee chair-people who are directly responsible for allowing such bills to be heard and passed on for a full vote, and letting them know that we want this medical treatment made available to our deserving veterans.

Read the bill:

Representative
Speaker of the House, repsay@Capitol.hawaii.gov

Representative
Chair, Public Safety and Military Affairs Committee, repaquino@capitol.hawaii.gov

Representative
Chair, Health Committee, repyamane@Capitol.hawaii.gov

About the author: Clifton Otto is a retina specialist here on Oahu, at the Retina Institute of Hawaii, where he supervises several ongoing national studies dealing with macular degeneration and diabetic retinopathy. He also worked as a natural products chemist at the University of Hawaii, and as a reference standard chemist at Wyeth-Ayerst Pharmaceuticals before attending medical school in New York.

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When the State of Hawaii decriminalized the medical use of Cannabis in 2000, it created an accepted medical use for a Schedule I controlled botanical drug substance. The State was well within its authority by doing so, as illustrated by the ruling in a contemporary Supreme Court case that affirmed the right of states to decide the medical use of controlled substances ¹. This is also illustrated by the Hawai`i Senate and House of Representative committee hearings in 1971 and 1972, during which the State version of the Federal Controlled Substances Act (CSA) was significantly modified to protect the State鈥檚 authority over controlled substances ².

The decriminalization of the medical use of Cannabis, provided by Hawai`i鈥檚 Medical Marijuana Program, allows registered patients with approved medical conditions to self-produce and self-administer Cannabis under medical supervision with certain limitations on the number of plants and amount of material that can be possessed³. This state-level medical use of Cannabis stands in stark contrast to the Federal CSA, which places Cannabis, along with LSD and Heroin, in Schedule I, meaning that it has no accepted medical use ⁴. However, it must be remembered that being placed in Schedule I is not a life sentence. The Federal CSA is specifically designed to provide non-federal entities with an administrative mechanism by which to apply for a reclassification of a controlled substance once a change in use has occurred⁵.

It should also be pointed out that there are actually two pathways for a Schedule I controlled substance to be moved to a less restrictive category. The first way involves the formal FDA-approved Phase I-III randomized clinical trials drug approval process that was designed to facilitate the development and marketing of single-agent pharmaceutical drug products. The second way, as exemplified by the Medical Cannabis Programs that sixteen states plus the District of Columbia have already created, is for a state to invoke its authority over the medical use of controlled substances and give a controlled substance a new medical use.

However, this is only the first step that a state must take along this path. Once Hawai`i created a medical use for a controlled substance, the state also obligated itself to comply with the Federal CSA and file a formal application with the Drug Enforcement Administration (DEA) in order to eliminate the current inconsistency between state and federal law. Once the State does its part by filing the application, the DEA is obligated to follow the guidelines of the Federal CSA and reclassify the controlled substance in question based on the new medical use that the State is reporting. It鈥檚 that simple, or at least it should be.

The problem is that the State of Hawai`i, with its eleven year-old Medical Cannabis Program operating in direct conflict with federal law, has yet to fulfill its legal obligation to the Federal CSA by initiating the reclassification process. By not doing so, the State is not only violating the Federal CSA and failing to protect the State鈥檚 right to decide the medical use of a controlled substance, but it is also putting its registered patients at undue risk of federal persecution and preventing the state from developing a properly regulated program.

The solution to this dilemma is rather straight forward, and involves a two-pronged approach. The first action required is for the State to file a formal application with the DEA, in accordance with 21 CFR 1308.43, to have Cannabis reclassified based on the 鈥渃urrently accepted medical use in treatment in the United States鈥� that exists by the very fact that Hawaii has a Medical Marijuana Program. Secondly, the State will also need to file a temporary and permanent injunction in U.S. District Court for the District of Hawai`i, on the same day that the DEA application is faxed and mailed overnight, enjoining any further enforcement of Cannabis as a Schedule I controlled substance while the application with the DEA is pending.

Under better circumstances, the DEA would have already recognized that Cannabis no longer meets Schedule I criteria, and would have initiated reclassification proceedings on its own in order to honor its responsibility for keeping the Federal CSA up to date. However, given the current federal stance on Cannabis, such motivation needs to be supplied by the State.

It should also be remembered that this is a legal issue, not a scientific one. The State has created an accepted medical use for a Schedule I controlled substance. This substance must therefore be rescheduled. End of discussion. It鈥檚 the State鈥檚 responsibility to alert the DEA to the change that has taken place, and then it鈥檚 the DEA鈥檚 obligation to invoke its rulemaking authority and decide, based on a review of all existing current scientific evidence, what would be the best classification for Cannabis. Regardless of how the DEA decides to reclassify, one thing is for certain: Cannabis can no longer be in Schedule I.

About the author: Clifton Otto is a retina specialist here on Oahu, at the Retina Institute of Hawaii, where he supervises several ongoing national studies dealing with macular degeneration and diabetic retinopathy. He also worked as a natural products chemist at the University of Hawaii, and as a reference standard chemist at Wyeth-Ayerst Pharmaceuticals before attending medical school in New York.

1.Gonzales v. Oregon, 546 U.S. 243, 258 (2006): 鈥淭he Attorney General has rulemaking power to fulfill his duties under the CSA. The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.鈥�

2.SSCR 527, Senate Journal – Standing Committee Reports, 1971, p. 1038, and HSCR 81-72, House Journal – Standing Committee Reports, 1972, p. 664. The Hawai`i State Uniform Controlled Substances Act became non-uniform with the Federal CSA when the legislature removed the Schedule I criteria 鈥渘o currently accepted medical use in treatment in the United States鈥�, thereby preserving the State鈥檚 right to decide on the medical use of controlled substances.

3.Hawai`i鈥檚 Medical Marijuana Program, administered by the Narcotics Enforcement Division of the Department of Public Safety, currently allows registered patients with certain qualifying conditions to cultivate no more than three flowering plants and four vegetating plants, and to possess no more than three ounces of 鈥渦sable鈥� material at any one time.

4.The Federal Controlled Substances Act, Article 2, Section 203, lists the following criteria for Schedule I inclusion: 鈥�(1) has high potential for abuse; (2) has no currently accepted medical use in treatment in the United States; and (3) lacks accepted safety for use under medical supervision.鈥�

5.21 CFR 1308.43, http://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_43.htm

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On June 14, 2000, Hawaii became the first state in the Union to create a Medical Cannabis Program (MCP) via the legislative process.

When Governor Cayetano signed SB 862 into law on that day eleven years ago, he, and the State of Hawai鈥檌, effectively told our Federal Government that we do not care what they think about Medical Cannabis; that we are giving this botanical medicine back to the patients who need it, whether they like it or not. This was a bold move at a time when only a handful of other states had enacted similar programs, and the War on Drugs was raging on unabashed.

Unfortunately, good intentions do not always guarantee successful results. This was especially true in the case of Hawai鈥檌鈥檚 MCP, where its founding fathers and mothers neglected to give patients legal access to their state-approved medicine, and placed its care in the hands of a state agency that has a direct conflict of interest with protecting the rights of patients who are being allowed to utilize a Schedule I controlled substance.

What was also left out of the original legislation was any means for Medical Cannabis research to be carried out at the state level. Such research is an essential part of any state-approved MCP, since this is the only way for patients to learn which strain of Cannabis contains the unique fingerprint of chemicals that is best for their condition, what the potency is of their medicine so that it can be properly dosed, and if there are any contaminants that could put them at risk for additional health problems.

The Department of Public Safety (DPS) will tell you that there already exists a mechanism for conducting research with controlled substances in Hawai鈥檌. And indeed, buried within Hawaii鈥檚 Revised Statues, Chapter 329, Part V, Section 58, there is a two sentence provision that places this authority squarely with the DPS. What is not so apparent though is that this applies only to research being conducted with Industrial Hemp, not Medical Cannabis.

If you wanted to initiate a research project involving Hemp, you would first have to build the facility that would house the plants, including a ten foot high chain link fence topped with barbed wire, along with the necessary security and surveillance equipment, which would then have to be inspected by the DPS before your application would even be considered.

Even then, if you made it through the DPS hoops, your application would still have to be reviewed by the Drug Enforcement Administration (DEA), which would inevitably mean years of delays and eventual rejection. And, if you wanted to conduct research using Medical Cannabis in Hawai鈥檌, you鈥檙e out of luck.

The DPS does not accommodate such requests, since the DEA maintains strict control over anything involving Cannabis Research. This includes a monopoly on the production of Research Cannabis through a single contract with the School of Pharmacy at the University of Mississippi, and a review process involving the National Institute on Drug Abuse (NIDA) that is biased towards approving only those protocols that are designed to show the negative effects of Cannabis.

Add on top of this the outdated Randomized Clinical Trials (RCT) methodology that the Food and Drug Administration (FDA) insists is the only way of proving the efficacy of a medication, within a system that was designed to favor the pharmaceutical development of a single therapeutic agent, and you have the perfect storm for insuring that Medical Cannabis Research can never be performed at the local level.

But why should we care what the FDA and the DEA thinks about doing research with Medical Cannabis? We didn鈥檛 care what they thought when Hawai鈥檌鈥檚 MCP was created. Why should this be stopping us now?

The fact is that Cannabis is a Common Wealth Botanical Medicine. It already belongs to the people who need it. The State of Hawai鈥檌 recognized that Cannabis has a place in our community as a botanical medicine when it created Hawai鈥檌鈥檚 MCP.

Patients are not using material from the University of Mississippi. They are using locally available strains of Cannabis that have been selected for sustainability in Hawai鈥檌鈥檚 climate and contain a unique spectrum of therapeutic chemicals that nobody has yet to investigate under controlled research conditions. And of these naturally occurring chemicals, THC, the psychoactive chemical that produces the 鈥渉igh鈥� that recreational users prefer, is one of the least interesting of the active ingredients in Cannabis.

Others, such as Cannabidiol, with its proven anti-tumor, anti-inflammatory, and neuroprotective properties, have the potential to fulfill Cannabis鈥� legacy as a locally available, widely therapeutic botanical medicine that can reduce our dependence on big pharmaceutical companies that care for nothing other than their annual fiscal reports.

We have the chance to do it right in Hawaii, by extending the state-sanctioned protection of Medical Cannabis to those professionals and well qualified scientists who are committed to keeping such research centered on the best interests of Hawai鈥檌鈥檚 patients.

About the author: Clifton Otto is a retina specialist here on Oahu, at the Retina Institute of Hawaii, where he supervises several ongoing national studies dealing with macular degeneration and diabetic retinopathy. He also worked as a natural products chemist at the University of Hawaii, and as a reference standard chemist at Wyeth-Ayerst Pharmaceuticals before attending medical school in New York.

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