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The Journal of the American Medical Association. “Only about 40 percent of approvals included trials in which the new drug was compared with existing drugs on the market.” Opponents of legalizing cannabis for medicinal purposes are fond
of arguing that the plant must be subjected to the same standards of clinical study and FDA review as conventional medicines. What they fail to mention is that cannabis and its active components have already been subjected to a greater degree of scientific scrutiny than many FDA-approved pharmaceuticals.
According to a just-published analysis of some 200 newly FDA-approved medications, few conventional drugs are tested in multiple, large-scale clinical assessing safety and efficacy trials prior to market approval. “[A]bout a third won approval on the basis of a single clinical trial, and many other trials involved small groups of patients and shorter durations,” reports theWashington Post in its summary of the study, which appears in the January edition of
By comparison, there exists 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 keyword search on PubMed Central, the government repository for peer-reviewed scientific research. Of these, more than 100 are controlled clinical trials assessing the therapeutic efficacy of cannabinoids for a variety of indications.
A 2006 review of 72 of these trials, conducted between the years 1975 and 2004, identifies ten distinct pathologies for which controlled studies on cannabinoids have been published. The review concludes that these trial data “affirm that cannabinoids exhibit an interesting therapeutic potential as antiemetics, appetite stimulants in debilitating diseases (cancer and AIDS), analgesics, as well as in the treatment of multiple sclerosis, spinal cord injuries, Tourette syndrome, epilepsy and glaucoma.”
A 2010 review of 37 additional controlled trials, conducted between the years 2005 and 2009, similarly acknowledges the plant’s efficacy, finding, “Based on the clinical results, cannabinoids present an interesting therapeutic potential mainly as analgesics in chronic neuropathic pain, appetite stimulants in debilitating diseases (cancer and AIDS), as well as in the treatment of multiple sclerosis.” The review estimates that some 6,100 patients suffering from a wide range of ailments have taken part in clinical cannabis trials over the past decades – a far greater cohort of subjects than would typically participate in clinical trials for more conventional therapeutics.
Most recently, a 2012 review of more recent clinical trials conducted by the California Center forMedicinal Research, involving several hundred patients, concluded emphatically: “Recent clinical trials with smoked and vaporized marijuana, as well as other botanical extracts, indicate the likelihood that the cannabin ids can be useful in the management of neuropathic pain, spasticity due to multiple sclerosis, and possibly other indications...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.”
The bottom line: Scientists now know more about cannabis as a medicine than regulators know about many of the FDA-approved pharmaceuticals that the plant could replace.
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