The anti-marijuana legalization group Smart Approaches to Marijuana (SAM) has issued recommendations to Congress for rule changes regarding research on marijuana. Among their six proposals are to allow multiple sites beyond the National Institute on Drug Abuse (NIDA) to grow and dispense research marijuana, to eliminate Public Health Service (PHS) oversight review for research applications, and to facilitate without Drug Enforcement Administration (DEA) involvement the marijuana component Cannabidiol, in hopes that it will have medical value.
These proposals are contrary to current law and even violate international treaties, but are said to be necessary, because NIDA has been too modest in exploring marijuana’s potential medical value, and because the federal government stands accused of “blocking” such research.
Reuters quotes UCLA Professor Mark Kleiman, who, they note, “was hired by Washington state to consult on its move to legalize marijuana,” as calling Smart Approaches to Marijuana's plan a good step. "I don’t think there's any question that cannabinoids (constituents of marijuana) have medical utility, and we have to find out what that is," Kleiman said.
Kleiman’s praise invokes an inappropriate standard for those seeking to develop new medications, however. We should not explore a substance because it “may have medical utility,” but rather, as for any pharmacological development (especially given the abuse potential of this drug), ask "is there a clinical need that can be met by a substance derived from marijuana, demonstrating acceptable safety in use, with established therapeutic value for a specific condition that equals or exceeds that of existing medications?”
Moreover, the demonstration of safety and therapeutic value must precede efforts to change the law to make the substance available.
SAM appears to be responding uncritically to activist claims that are misleading, and their “solution” will be counter-productive. Importantly, it does not solve the problem of marijuana research that it was designed to address. Though legalizers blame government control of the drug, in reality the impediments are found in the nature of proper clinical trials.
It is difficult to design a research protocol concerned with a non-purified, non-standardized substance, most commonly smoked, that is a compound of multiple chemicals, some which are known to be dangerous, with no established dose for any specific medical condition.
Mere “shot-gunning” for potential value is not a proper research protocol. The point of having NIDA and PHS review committees is to ensure that proposed protocols are sufficiently rigorous that the results can be meaningfully interpreted Claims of therapeutic value have not met the standards to which any drug is subjected, and so far, research that has been conducted suffers from small numbers of participants whose adherence to double-blind, case-controlled conditions is problematic.
Moreover, inadequate research protocols threaten to provide findings that would be, in reality, false positives, if the claimed medical value is illusory. Were we to provide the substance as an approved medicine where safety and efficacy have not been carefully controlled and demonstrated we can actually harm patients suffering from multiple medical conditions (such as veterans suffering Post Traumatic Stress Disorder).
Finally, by removing the stricture of having one official source for the drug with appropriate review panels, the door is open to potential abuse of medical pronouncements by activists, who might conduct “science by press release.” This happens where tentative and non-replicated results are allowed to drive headlines and build political pressure for greater acceptance of the substance, a scenario similar to that shown this week by retracted political science results published in the journal Science
Encouraging “multiple centers” that are given authority to dispense marijuana runs the risk that they will provide the drug to political activists. The work of such activists, working in coordination with a compliant and pro-marijuana press, is a situation that is not likely to provide sound medical outcomes.
We would look askance at calls to “loosen up” research protocols to explore the medical value of vodka under pressure from corporations that market alcohol, as well as studies undertaken by commercial alcohol enterprises, or even researchers operating with alcohol industry grants. In fact, we already experience concern when pharmacological companies are felt to be too involved in studies of new drugs that they themselves hope to market.
Finally, the call to abandon current DEA supervised strictures, or to rush forward with a special dispensation for the (presumed) safer and potentially beneficial Cannabidiol, in the absence of actual demonstration in clinical trials that Cannabidiol has these characteristics, is unwise, at best. If and when Cannabidiol has proven merit, it is unlikely to be offered as a raw, smoked plant, but will rather be a purified, synthesized medicine.
A sensible person should always ask, “Of all the medications available today—including many that are dangerous and subject to abuse—why is marijuana the +only+ substance that cannot demonstrate effectiveness and safety within established protocols?” Well, actually, there are medications based on marijuana that have been proven safe and effective for some conditions, and they are currently available for prescription.
If more components of cannabis are worthy new medicines, they too should be scientifically proven and handled within established structures. Research into any drug, including marijuana, should be independently validated, and held to strict medical standards, to protect the integrity of a medical system that serves and protects all Americans.