Review Identifies 140 Controlled Clinical Trials Related to Cannabis

Marijuana researchScientists have conducted over 140 controlled clinical trials since 1975 assessing the safety and efficacy of whole-plant cannabis or specific cannabinoids, according to a new literature review published in the journal Critical Reviews in Plant Sciences.

A pair of German researchers identified 140 clinical trials involving an estimated 8,000 participants. Of these, the largest body of literature focused on the use of cannabis or cannabinoids in the treatment of chronic or neuropathic pain. Authors identified 35 controlled studies, involving 2,046 subjects, assessing the use of marijuana or cannabinoids in pain management. In January, the National Academy of Sciences acknowledged that “conclusive or substantial evidence” exists for cannabis’ efficacy in patients suffering from chronic pain.

Cannabinoids have also been well studied as anti-emetic agents and as appetite stimulants. Researchers identified 43 trials evaluating marijuana or its components for these purposes, involving total 2,498 patients. They also identified an additional 14 trials examining the role of cannabis or cannabis-derived extracts in the treatment of multiple sclerosis.

Researchers also identified several additional trials evaluating the use of cannabis or cannabinoids for Crohn’s disease, Tourette’s syndrome, Parkinson’s disease, glaucoma, epilepsy, and various other indications.

A 2014 study published in the Journal of the American Medical Association reported that new drugs typically gain FDA approval on the basis of one or two pivotal clinical trials.

Full text of the study, “Medicinal uses of marijuana and cannabinoids,” appears online here.

Scientific Review: “There Is Now Clear Evidence That Cannabinoids Are Useful For The Treatment Of Various Medical Conditions”

For the second time in recent months, a scientific paper published in a peer-reviewed journal has thoroughly rebutted the present Schedule I status of cannabis under US federal law, which states that the plant and its organic constituents possess a “high potential for abuse,” and that they lack “accepted medical use” and “accepted safety … under medical supervision.”

According to a just published review in the German scientific journal Deutsches Ärzteblatt International, scientific findings from over 100 controlled clinical trials involving either cannabis or its constituents provide “clear evidence that cannabinoids are useful for the treatment of various medical conditions.”

Investigators from the nova-Institute and the Hannover Medical School in Germany reviewed over 100 controlled trials assessing the safety and efficacy of cannabis and cannabinoids.

Researchers reported: “Knowledge about the therapeutic potential of cannabis products has been greatly improved by a large number of clinical trials in recent years. … There is now clear evidence that cannabinoids are useful for the treatment of various medical conditions,” including chronic neuropathy (nerve pain), multiple sclerosis, HIV/AIDS, Gilles de la Tourette syndrome, and other indications.

Regarding the safety profile of cannabis and cannabinoids, investigators determined: “The most common side effects of cannabinoids are tiredness and dizziness (in more than ten percent of patients), psychological effects, and dry mouth. Tolerance to these side effects nearly always develops within a short time. Withdrawal symptoms are hardly ever a problem in the therapeutic setting.”

Authors did express concern that cannabis could pose additional health risks for adolescents and/or pregnant or breast-feeding women, as well as individuals diagnosed with Hepatitis C, severe cardiovascular disease, addictive disorders, or those vulnerable to certain psychiatric disorders, such as schizophrenia.

Investigators acknowledged that cannabis dosing may adversely impact psychomotor skills. However, they noted, “Patients who take cannabinoids at a constant dosage over an extensive period of time often develop tolerance to the impairment of psychomotor performance, so that they can drive vehicles safely.”

They concluded, “No acute deaths have been described that could be unequivocally attributed solely to cannabis consumption or treatment with cannabinoids.”

This most recent paper follows the publication of a similar review, published in May in The Open Neurology Journal. In that paper, investigators with the University of California at San Diego and the University of California, Davis concluded: “Evidence is accumulating that cannabinoids may be useful medicine for certain indications. Based on evidence currently available, the (federal) Schedule I classification (of cannabis) is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.

In 2011, the Obama administration — via the United States Drug Enforcement Administration (DEA) — formally denied a nine-year-old administrative petition filed by NORML and a coalition of public interest organizations calling on the agency to initiate hearings to reassess the present classification of marijuana as a schedule I controlled substance. In her denial of the petition, DEA administrator Michele Leonhart alleged: “[T]here are no adequate and well-controlled studies proving (marijuana’s) efficacy; the drug is not accepted by qualified experts. … At this time, the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.”

In June, Ms. Leonhart testified before Congress that she believed that heroin and marijuana posed similar threats to the public’s health because, in her opinion, “all illegal drugs are bad.”

Coalition advocates are presently appealing the DEA’s denial of their petition in federal court.

Full text of the most recent study, “The therapeutic potential of cannabinoids,” is available online here.

Does Science Matter?

As I wrote last week in an op/ed for The Sacramento Bee, when it comes to the federal government’s policy on marijuana, not so much.

Viewpoints: Science supporting medicinal pot is clear
via The Sacramento Bee

A dozen years ago, California lawmakers did something extraordinary. They authorized investigators throughout California to conduct a series of FDA-approved, gold standard trials to assess whether cannabis is safe and effective as a medicine.

In all, researchers conducted more than a dozen clinical studies examining whether cannabis could meet objective standards of safety and therapeutic efficacy. For example, investigators at the University of California, San Francisco, assessed whether vaporizing cannabis could rapidly and consistently deliver the plant’s active ingredients to patients in a manner that is far safer than smoking. It could. At UC San Diego, clinicians examined whether inhaling cannabis posed potential harms to the immune system, particularly in subjects suffering from immune-compromised conditions like HIV. It didn’t. And at universities throughout the state, investigators studied whether marijuana provided statistically significant relief in a number of hard-to-treat conditions, such as multiple sclerosis and neuropathic (nerve) pain. Cannabis did so – consistently.

… Nonetheless, policymakers – particularly those in Washington – have responded to these most recent scientific findings with no more than a collective yawn. Despite pledging to let “science and the scientific process … inform and guide decisions of my administration,” neither President Barack Obama nor Congress have taken any steps to amend federal law or federal policy to reflect the scientific reality that marijuana possesses well-established therapeutic value. In fact, this administration has taken just the opposite approach.

In 2011, the Obama administration quashed out-of-hand an administrative petition that sought federal hearings regarding the present classification of cannabis as a substance with “no currently accepted medical use in treatment in the United States.” In its rejection, the administration alleged, “The drug’s chemistry is not known and reproducible; there are no adequate safety studies; there are no adequate and well-controlled studies proving efficacy; the drug is not accepted by qualified experts; and the scientific evidence is not widely available.”

Yet, the findings from California’s 12-year-old study program show that each of these claims is demonstrably false.

It is long past time to reject the notion that we as a society possess insufficient evidence regarding the safety and efficacy of cannabis. The truth is that we know plenty. Most of all we know that there remains no valid scientific reason to justify the continued targeting, prosecution and incarceration of those Americans who consume cannabis responsibly.

Read my entire commentary here.

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