BETWEEN THE AISLES: Bill would make way for medicinal marijuana clinical trials

Road to legalization is a rocky one in Kentucky

By Kevin Wheatley, Published:

Medical marijuana has been a topic for debate with no prospect of advancing in this year’s legislative session.

But Sen. Denise Harper Angel hopes a bill she filed Thursday calling for clinical trials of the illicit substance will provide a starting point for officials to study its medicinal benefits.

Senate Bill 236, filed on the last day for new bills, would direct fees currently assessed on insurers for Kentucky Access — a health insurance program for high-risk patients that is winding down with the state’s health benefit exchange in place — toward a fund for clinical health trials beginning March 31, 2015.

Angel, D-Louisville, said that amounts to about $28 million, half of which would be directed toward medicinal marijuana trials at the University of Louisville. The University of Kentucky, the state’s other public medical research institution, and U of L would apply to a nine-member governing board for the remaining funds, which could be boosted from appropriations by the Legislature, grants and interest generated in the fund account, according to the bill.

“As we’ve discussed cannabidiol and medical marijuana through committee meetings, the main issue is people fear there’s not been enough clinical trials, and so I found a funding mechanism,” Angel said, noting SB 236 would mandate a 20-year strategic plan that can be amended every two years. “I think this can be a wonderful thing long-term for the future.”

Medical marijuana research will attract a lot of attention, but Angel said her bill would also open the door for further studies on diseases such as Alzheimer’s and breast cancer.

Though the path for the legalization of medicinal marijuana is rocky, the Senate is considering a bill that would make cannabidiol — a non-intoxicating oil produced from cannabis — legal to prescribe by physicians practicing at UK or U of L. 

Senate Bill 124, which cleared the Senate Health and Welfare Committee Feb. 26, would also make the substance available to those participating in studies approved by the U.S. Food and Drug Administration.

Senate President Robert Stivers was noncommittal on his opinion of SB 236, though he said he would like to see additional independent research on marijuana’s therapeutic or medicinal benefits.

“If that’s an appropriate use of the money, I’ll withhold judgment,” said Stivers, R-Manchester. “Is that a valid question to ask about, we should have a study before we make a decision? I think that is a very valid question.”

House Speaker Greg Stumbo said the clinical trials on medical marijuana and funding mechanism proposed in SB 236 are “not a bad idea.” Stumbo, D-Prestonsburg, has supported further debate on medicinal cannabis since hearing of its benefits in alleviating problems associated with autism.

“One of the concerns about medical marijuana is obviously that there hasn’t been a great deal of research done on it because it’s been illegal, so I favor any research effort that can be made,” he said.

With the federal government’s relaxing stance on cannabis issues regarding states that have legalized the recreational and medicinal use of marijuana, it’s unclear how much red tape would stand between Kentucky and medical marijuana trials.

Stumbo said the U.S. Drug Enforcement Agency has operated with a “hands-off attitude” thus far, and Stivers said the matter could be settled with an executive order from the president.

“I’m sure there’d need to be some clarification, but if they’re not going to punish people for possession, they damn sure ought to not punish people for research on it,” Stumbo said.

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  • CNN's Dr. Sanja Gupta has two documentaries, one of which was just aired, that explains how hard DEA makes it for anyone to do clinical reasearch with medical marijuana...not just to see if it is safe or effective (that was established LOOOG ago), but to determine what is the best way to admninister it for maximum benefit.  Check out the latest WEED II on youtube here.  The personal stories are very compelling.

    http://www.youtube.com/watch?v=a2SpiaHJ41g

  • To date, there are over 20,000 published studies or reviews in the scientific literature referencing the cannabis plant and its cannabinoids, nearly half of which were published within the last five years according to a key word search on the search engine PubMed Central, the US government repository for peer-reviewed scientific research. PubMed is on line.  While much of the renewed interest in cannabinoid therapeutics is a result of the discovery of theendocannabinoid regulatory system, some of this increased attention is due to the growing body of testimonials from medical cannabis patients and their physicians.  The scientific conclusions of the overwhelmingly majority of modern research directly conflicts with the federal government's stance that cannabis is a highly dangerous substance worthy of absolute criminalization. Please don't get me wrong.  Clinical studies are a good idea but trials will likely be done by GW Pharmaceuticals who are already prescribing a cannabis plant extract in 25 countries.  Or you might want to talk to the owner of U.S. Patent 6630507.   The U.S. government through U.S.Health and Human Services owns a patent that lists the use of certain cannabinoids found within the cannabis sativa plant as useful in neurodegenerative diseases such as Alzheimer's, Parkinson's, and HIV dementia.  They also patented these substances as antioxidants.  This plant has been studied more than almost any other plant and has far more research already done than most common medicines.  It is a plant, for Christ's sakes, it's not a chemical that the FDA can approve or disapprove eventhough they acknowlege the medicine in parts of the plant. The call for more studies has always been a delay tactic.  The only way to say that you don't know enough is not to look! Could someone please let the rest of us know that would like to see this plant legalized and regulated just how many studies you require so that we don't bug you before its time to say that we know enough.

  • "Overall these studies have shown drivers who use marijuana get into accidents at the same rate as drivers who do no drugs or alcohol, and in truth the best way to determine how impaired a person is, in the case of marijuana use, is the old ‘walk the line’ test."

    I have never seen or read about anyone being so stoned that they could not pass a field sobriety test...that is because marijuana does not effect the body's coordination and motorskills enough to be considered an impairment.  Marijuana is NOT an intoxicant like most any other drug...it works in a completely unique way and in most cases those try it intiallly do not even feel any effects of it until their brains learn what to look for which may take up to a week of daily use.  The best description that I have ever heard came from Dr. Andrew Weil who did a lot of testing back in the early 70's, when he described it as an active plecebo.  By that he meant that people actually do not get high on the constituents of the THC drug, but that these chemical compounds cause the body to produce its own naturally occuring hormonal cocktail consisting of beta endorphines, dopamine, etc. 

  • ~~During the Kentucky House Health and Welfare Committee hearing held on Thursday February 26th, 2014, on HB350 the Cannabis Compassion Act, Representative Robert Benvenuti held up a study and, waving it around like McCarthy saying he has the list of Commies right here, proceeded to claim that, “traffic fatalities in Colorado, after passage of the medical marijuana law, increased 114%.”
    The study can be accessed here thru an article in Forbes magazine which reviewed the study--   http://www.forbes.com/sites/jacobsullum/2014/02/17/if-medical-marijuana-laws-cause-a-surge-in-drugged-driving-deaths-why-are-fatalities-falling/
    Representative Benvenuti failed to mention that the study he cites did not determine whether or not marijuana was the cause of the accidents, only that marijuana was present in toxicology tests.  Given that the metabolites in marijuana are present as much as 3 weeks after use, the level of metabolites has no correlation to a person’s level of impairment. Dr. Guohua Li one of the authors of the study was quoted in the Denver Post as saying, “The most likely explanation, (for the increased presence of marijuana), is that the use of marijuana in the general driver population has been increasing, which may reflect increased use in the general population.”  Li said the Federal data cannot show whether the drivers were impaired by marijuana at the time of the crash; a positive test may indicate use as long as several days prior, and this study also did not look at whether the drivers were at fault in the crash.
    Most of the reliable and respected studies done on the issue of marijuana and driving can be found here--   http://norml.org/library/item/marijuana-and-driving-a-review-of-the-scientific-evidence
    Overall these studies have shown drivers who use marijuana get into accidents at the same rate as drivers who do no drugs or alcohol, and in truth the best way to determine how impaired a person is, in the case of marijuana use, is the old ‘walk the line’ test.  If there really was an increase in traffic fatalities of the magnitude claimed by Representative Benvenuti it would have been top headlines in papers across the nation.
    Certainly as we move from propaganda, suppression and enforcement to a scientific and realistic approach to marijuana use we must be careful.  Representative Benvenuti is calling for research.  There is plenty of research, just none approved by the Federal Government!  For example, a Food and Drug Administration approved protocol for a study of marijuana for symptoms of Post-Traumatic Stress Disorder in US Veterans has been on hold for over 3 months waiting for the US Public Health Service to sell researchers the Government approved marijuana for the study.  In the 40 plus years since enactment of the 1970 Controlled Substances Act the US Public Health Service has never provided the marijuana for any research and so far not for this Study either.  No ‘approved’ research, thus allowing the Government to claim they can’t legalize or reschedule marijuana because there is no Government approved research showing marijuana is safe or has any medical value!  Actually there is plenty of evidence, some of it gold standard research, showing the safety and efficacy of marijuana, just none supporting the ridiculous claims of the Government.
    At present, 20 States and the District of Columbia have found this medicine safe for their citizens to use.  Two have legalized it for recreational use.  There is nothing to suggest it will not be safe for our citizens.  If we combine Senator Denton’s bill with Representative Marzian’s HB350, then Representative Benvenuti will get his research, and the citizens who need this medicine now will get their medicine.  A win-win for all!
     

     

  • “One of the concerns about medical marijuana is obviously that there hasn’t been a great deal of research done on it because it’s been illegal, so I favor any research effort that can be made,” he said.

    What?  There are presently 20 states and the District of Columbia that allow at least the use of medical marijuana and 15 states (including KY) with legislation pending to allow the use.  The KY legislature doesn't have to reinvent the wheel here or imagine what would happen if they legalized medical marijuana, all they have to do is observe what has and has't happened in states that have had it for over a decade.  What hasn't happened are all of the naysayer's and the police's horror stories that are little more than myths and derogatory epithets. 

    "Humans have cultivated and consumed the flowering tops of the female cannabis plant, colloquially known as marijuana, since virtually the beginning of recorded history. Cannabis-based textiles dating to 7,000 B.C.E have been recovered in northern China, and the plant's use as a medicinal and mood altering agent date back nearly as far. In 2008, archeologists in Central Asia discovered over two-pounds of cannabis in the 2,700-year-old grave of an ancient shaman. After scientists conducted extensive testing on the material's potency, they affirmed, "[T]he most probable conclusion ... is that [ancient] culture[s] cultivated cannabis for pharmaceutical, psychoactive, and divinatory purposes."

    "Cannabinoids have a remarkable safety record, particularly when compared to other therapeutically active substances. Most significantly, the consumption of marijuana -- regardless of quantity or potency -- cannot induce a fatal overdose. According to a 1995 review prepared for the World Health Organization, "There are no recorded cases of overdose fatalities attributed to cannabis, and the estimated lethal dose for humans extrapolated from animal studies is so high that it cannot be achieved by ... users.""

    Modern cultures continue to indulge in the consumption of cannabis for these same purposes, despite a present-day, virtual worldwide ban on the plant's cultivation and use. 

    There exists little if any scientific basis to justify the federal government's present prohibitive stance and there is ample scientific and empirical evidence to rebut it. Despite the US government's nearly century-long prohibition of the plant, cannabis is nonetheless one of the most investigated therapeutically active substances in history. To date, there are over 20,000 published studies or reviews in the scientific literature referencing the cannabis plant and its cannabinoids, nearly half of which were published within the last five years according to a key word search on the search engine PubMed Central, the US government repository for peer-reviewed scientific research. While much of the renewed interest in cannabinoid therapeutics is a result of the discovery of theendocannabinoid regulatory system (which is described in detail later in this booklet), some of this increased attention is also due to the growing body of testimonials from medical cannabis patients and their physicians.

    The scientific conclusions of the overwhelmingly 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, in February 2010 investigators at the University of California Center for Medicinal Cannabis Research publicly announced the findings of a series of randomized, placebo-controlled clinical trials on the medical utility of inhaled cannabis. The studies, which utilized the so-called 'gold standard' FDA clinical trial design, concluded that marijuana ought to be a "first line treatment" for patients with neuropathy and other serious illnesses.

    Several of studies conducted by the Center assessed smoked marijuana's ability to alleviate neuropathic pain, a notoriously difficult to treat type of nerve pain associated with cancer, diabetes, HIV/AIDS, spinal cord injury and many other debilitating conditions. Each of the trials found that cannabis consistently reduced patients' pain levels to a degree that was as good or better than currently available medications.

    Another study conducted by the Center's investigators assessed the use of marijuana as a treatment for patients suffering from multiple sclerosis. That study determined that "smoked cannabis was superior to placebo in reducing spasticity and pain in patients with MS, and provided some benefit beyond currently prescribed treatments."

    A summary of the Center's clinical trials, published in 2012 in the Open Neurology Journal, concluded: "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."

    http://norml.org/component/zoo/category/recent-research-on-medical-marijuana