Letting the Science, Not the Politicians, Decide About Marijuana

In the commotion surrounding the Obama administration's favorable recent medical marijuana policy memo, a crucial part of the story has gone untold: For decades, the federal government has effectively blocked the standard Food and Drug Administration (FDA) development process that would allow for the marijuana plant to be brought to market as a prescription medicine, and -- so far -- President Obama is continuing this policy.

This frustrating reality belies the recent pronouncements of pundits and policymakers implying that the FDA has already dismissed the medical benefits of marijuana or that proponents have simply failed to explore FDA approval. Nothing could be further from the truth.

While there is a plethora of scientific research establishing marijuana's safety and efficacy, the specific clinical trials necessary to bring the marijuana plant to market as a prescription medicine are brazenly obstructed, not by the FDA, but by the Drug Enforcement Administration (DEA) and the National Institute on Drug Abuse (NIDA). Largely out of public view, for more than four decades DEA and NIDA have blocked drug development research by maintaining a government monopoly on the supply of marijuana that can legally be used in research.

You see, marijuana remains the only Schedule I drug that DEA prohibits from being produced by private laboratories for scientific research. Although DEA has licensed multiple privately-funded manufacturers of all other Schedule I drugs, it permits just one facility, located at the University of Mississippi, to produce marijuana for research purposes. This facility, under contract with NIDA, holds a literal monopoly on the supply of marijuana available to scientists, including researchers seeking to conduct FDA-approved studies of the plant's medical properties - studies that, of course, squarely conflict with NIDA's mission to study drug abuse. NIDA has refused to provide marijuana for two FDA-approved studies, and for six years has refused to sell 10 grams for non-human research into marijuana vaporizers.

Yet, even for researchers whose protocols it approves -- after a redundant review process that can add years of delay, compared to FDA's strict 30-day review period -- NIDA provides inferior, low-potency marijuana. What's worse, NIDA is authorized to grow marijuana for research but not for commercial prescription use, and therefore cannot provide the same material for prescription use should FDA approve it. Potential sponsors of medical marijuana research, after spending millions of dollars on studies, could turn only to NIDA's grower to purchase marijuana for sale as a prescription medicine.

DEA, meanwhile, protects NIDA's monopoly by refusing to license alternate suppliers - again, a situation unique to marijuana. Seeking to break the marijuana monopoly, in 2001, University of Massachusetts-Amherst Professor Lyle Craker applied to DEA for a Schedule I license to cultivate research-grade marijuana for use in FDA-approved clinical trials. After years of bureaucratic stonewalling and several lawsuits, in February 2007, DEA's own Administrative Law Judge (ALJ) finally issued a strongly worded -- but nonbinding -- decision that licensing Craker's proposed facility would be in the public interest. Following two more years of delay and just one week before George W. Bush left office, DEA administrators officially rejected the ALJ's conclusion and denied Craker's application - a decision that has been temporarily halted following the inauguration of President Obama.

DEA's systematic obstruction of FDA-approved research is clearly an inappropriate insertion of political ideology into science. The bad news - and the good news - is that Bush appointees are still running DEA. Obama should make it a priority to appoint new leadership at DEA that will base policy on evidence and the public interest rather than block legitimate science for short-sighted political ends.