DEA Action Continues Catch-22 of Marijuana Research
By Lynn R. Webster, MD
A 57-year-old firefighter with chronic neck and back pain left a comment on my blog asking, “If they can send a man to the moon, why can’t they make a medication with no side effects that is not addictive and that can control pain?”
My response is that we have the ability, but not the will. To find safer, more effective analgesics, we first must prioritize the search but have failed to set a national policy to do so. The search will take time and commitment, because psychoactive properties, which may prove harmful, have been difficult to isolate and eliminate from compounds that also have sufficient analgesic properties to relieve severe pain.
A Catch-22
Take, for example, the marijuana issue. The Drug Enforcement Administration (DEA) recently denied a petition to move marijuana out of Schedule I, the most restrictive category under the Controlled Substances Act (CSA), citing a high potential for abuse, no accepted medical use in the United States and an unacceptable level of safety for use even under medical supervision (Denial of Petition To Initiate Proceedings To Reschedule Marijuana, 81 Fed Regist 53688 [Aug. 12, 2016] [to be codified at 21 CFR Chapter II and Part 1301]). The action continues the catch-22 described in my previous Pain Medicine News column, in which the restrictive scheduling severely constrains the research needed to conclude whether marijuana has safe and effective medical uses in pain treatment (“Chronic Pain’s ‘Medical Refugees’: What Muddled Medical Marijuana Laws Have Wrought.” 2016;14[3]:14).
In theory, the DEA supports efforts to research the medical potential of marijuana—an agency representative pointed out that the DEA has never denied a request to conduct research that was filed using FDA protocols. However, the DEA may be operating with a law enforcement bias in keeping with its role to enforce the CSA and, perhaps, reinforcing a stigma that dates from the Nixon administration (the 1970s) when the agency was charged with preventing drug abuse.
A case in point: A blogger for The Washington Post took Chuck Rosenberg, the DEA acting administrator, to task for comments calling medical marijuana “a joke” and exhibiting hesitation in conceding that heroin may be more dangerous (“The DEA Chief Called Medical Marijuana ‘a Joke.’ Now Patients Are Calling for His Resignation.” Washington Post Nov. 10, 2015). A DEA representative later walked back Mr. Rosenberg’s comments, and said he was addressing smoked marijuana and conceded that certain marijuana components have shown promise as medicines, but also stressed that these components lack safety and efficacy data sufficient for approval as medicines.
And so we come full circle with that catch-22 again. Yet with few safe and effective pain treatments, federal drug policy regulators should take seriously that marijuana has not been associated with overdose deaths, as distinguished from prescribed and nonmedical opioids. They also should weigh carefully evidence from the National Bureau of Economic Research that indicates states with medical marijuana dispensaries had an associated 15% to 35% decrease in substance abuse admissions for opioids and similar reductions in opioid-related overdose deaths and abuse from prescription opioids (“How Medical Marijuana Could Literally Save Lives.” Washington Post July 24, 2015).
Indeed, much of the tension over marijuana appears to stem from official fears that medical marijuana is not well regulated. This is a position espoused by the American Medical Association, which—while calling for the loosening of regulation to facilitate research—simultaneously warns of a lack of safeguards at the clinical level. Rep. Andy Harris (R-Md.), who opposes legalizing marijuana, has taken positions to prevent it, as a psychoactive substance, from becoming more available to the population at large. He, too, understands the catch-22 of research restriction.
Legislative Hope
There is hope, then, that restrictions hampering research may be lifting. Rep. Harris, along with Reps. Earl Blumenauer (D-Ore.), Sam Farr (D-Calif.) and H. Morgan Griffith (R-Va.), have introduced legislation to “cut through the red tape” of marijuana research (“Don’t Reclassify Marijuana Yet—Research It.” Washington Post Aug. 15, 2016).
If it becomes law, the Medical Marijuana Research Act of 2016 would:
- expand the number of research facilities (currently, the University of Mississippi is the only federally licensed place to grow marijuana for research purposes);
- cut down on the time it takes for researchers to acquire research-grade marijuana (it can often take years);
- remove levels of federal review to approving research (currently, the DEA, the FDA and, sometimes, the National Institutes of Health must sign off);
- shorten the window of time to approval; and
- change criteria for approval to presume the research is in the public interest unless otherwise shown.
This “carve-out” legislation would not change marijuana’s schedule but would provide a thoughtful step forward to ensure marijuana is subject to the same standards of safety and efficacy as other FDA-approved medications.
Meanwhile, the glacial pace of necessary research conflicts with the need of patients with pain and the widespread public health disaster of misused opioids. With new legislation on the horizon to cut out regulatory obstacles to research, is this the year we will find the will to do better?
Lynn R. Webster, MD, is a past president of the American Academy of Pain Medicine and author of the award-winning book, “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.” Visit www.thepainfultruthbook.com. He also is a member of the Pain Medicine News editorial advisory board. He lives in Salt Lake City.
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