Op-ed columnists Benton Bodamer and Rachel Friedman provided their views on the regulation of cannabidiol in Sunday’s Dispatch. I can’t speak to their legal acumen but their statements indicate they know little about science and responsible drug development.
Bodamer describes CBD as “…a nonpsychoactive chemical compound with promising therapeutic and entirely benign nontherapeutic uses that happens to be produced from cannabis plants.”
First, “promising” doesn’t mean “proven.” Only 8 percent of investigational drugs that start testing in humans become FDA-approved. Second, agents with activity against a disease almost always have adverse side effects. For example, in a randomized trial examining the effects of cannabidiol on drop seizures in Lennox-Gastaut Syndrome, cannabidiol was more effective than placebo but also produced somnolence, decreased appetite and diarrhea, causing some to discontinue their participation in the trial. Bodamer asserted that, “There are restaurants in California serving CBD oil-infused foie gras tacos right now, and the only people getting sick are the cost-averse.” Offering this colorful information as evidence of CBD’s safety is ridiculous. There is no information about the “dose” of CBD received by the restaurant’s patrons. It could be much lower than what patients need in order to experience therapeutic effects of CBD.
Friedman relied upon “…polling (that) demonstrates that there is overwhelming public sentiment to legalize marijuana in the U.S. for medical purposes” and that “…growing anecdotal evidence indicates that consumers are finding relief from such products.” Over many decades, the experience of those in medicine has shown that anecdotes and appeals to popularity have misled many and harmed patients. The drug-approval process used by the U.S. Food and Drug Administration did not arise in a vacuum. Careful observations that can be verified and assessed by disinterested parties tell us much about which drugs are effective for what diseases, at what dose, route and frequency, and whether the benefits outweigh the risks.
Anecdotes which represent coincidence but pass for causation fall far short of this standard and do not provide a comprehensive picture. Bodamer and Friedman advocate for a “science-based approach” and “safe consumer standards” for CBD. On that we agree. But this will involve rigorous scientific study using clinical trials, not extrapolation based on what is served in fancy California restaurants or the latest opinion poll.
Lynn Shaffer, Columbus
Source: http://www.dispatch.com/opinion/20180912/letter-columnists-have-rushed-to-judgment-of-cbd