This is Why DEA Action Continues Catch-22 of Marijuana Research


This is Why DEA Action Continues Catch-22 of Marijuana Research, Lynn R Webster, MD, @lynnrwebstermd

A 57-year-old firefighter with chronic neck and back pain left a comment on my blog to ask:

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 do 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.

The Marijuana Issue 

Take, for example, the marijuana issue. The Drug Enforcement Administration (DEA) recently denied a petition to move marijuana out of Schedule 1, the most restrictive 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. Reg. 53688 [August 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. (Webster LR. Chronic Pain’s ‘Medical Refugees’: What Muddled Medical Marijuana Laws Have Wrought. Pain Medicine News. April 14, 2016).

In theory, the DEA supports efforts to research the medical potential of marijuana — a spokesperson 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 when the agency was charged with preventing drug abuse.

Case in point: A blogger for the Washington Post took Chuck Rosenberg, DEA acting administrator, to task for comments calling medical marijuana “a joke” and exhibiting hesitancy in conceding that heroin may be more dangerous (Ingraham C. The DEA chief called medical marijuana ‘a joke.’ Now patients are calling for his resignation. Washington Post. November 10, 2015). A DEA spokesperson later walked back Rosenberg’s comments, and said that he was addressing smoked marijuana, 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.

The Marijuana Catch-22 — Again

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 an overdose death as distinguished from prescribed and non-medical opioids. They should also weigh carefully evidence from the National Bureau of Economic Research that indicates states with medical marijuana dispensaries had an associated 15 to 35 percent decrease in in substance-abuse admissions for opiates and similar reductions in opiate-related overdose deaths and abuse from prescription opioids (Ingraham C. 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, a position espoused by the American Medical Association, which – while calling for loosening of regulation to facilitate research – simultaneously warns of a lack of safeguards at the clinical level. Rep. Andy Harris (R-Md.), who opposes legal marijuana, has taken positions to prevent marijuana, as a psychoactive substance, from becoming more available to the population at large, but also understands the Catch-22 of research restriction.

Research Restrictions MAY be Lifting 

There is hope, then, that restrictions hampering research may be lifting. Harris, along with Rep. Earl Blumenauer (D-Ore.), Rep. Sam Farr (D-Calif.), and Rep. H. Morgan Griffith (R-Va.), have introduced legislation to “cut through the red tape” of marijuana research (Editorial Board. Don’t Reclassify Marijuana Yet – Research it. Washington Post. August 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 (currently, 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 windows of time to approval
  • Change criteria for approval to presume the research is in the public interest unless otherwise demonstrated

This “carve-out” legislation would not change marijuana’s schedule, but would provide a thoughtful step forward to insure 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?

Originally published in the November 2, 2016 edition of Pain Medicine News:


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Copyright 2016, Lynn Webster, MD




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