The federal govt. is still blocking the process that would allow the marijuana plant to be brought to market as a prescription medicine.
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.
But the Obama administration already has the power to break the absurd DEA stranglehold on medical marijuana research and jump-start the FDA development process by simply approving the ALJ’s comprehensive recommendation. U.S. Department of Justice head Eric Holder, the very man who just issued favorable guidelines on state medical marijuana laws, oversees the DEA and can grant Craker’s license at anytime.
The criminalization of marijuana has, of course, never been about science. In a 1989 case, a previous DEA Administrative Law Judge, Francis Young, ruled that marijuana should be re-scheduled, famously concluding, “Marijuana is one of the safest therapeutically active substances known to man.” DEA responded then the same way it has responded now – first ignoring the decision, then rejecting it.
Shortly after taking office, Obama issued a “scientific integrity presidential memorandum” promising that his administration would base policies on science, not politics. Last week, Drug Czar R. Gil Kerlikowske, the director of the White House Office of National Drug Control Policy, responded to the new federal stance on state medical marijuana laws by arguing that the plant is not a legitimate medicine because it has not been approved by the FDA: “Regarding state ballot initiatives concerning ‘medical’ marijuana, I believe that medical questions are best decided not by popular vote, but by science.”
I hope that the gatekeepers overseeing Craker’s application share the Drug Czar’s sentiments. Sick people who depend on marijuana, as well as doctors and scientists, are hoping that the Obama administration will have the courage and common sense to let science resolve the controversy over marijuana’s medical uses.
Otherwise, expect that advocates for medical marijuana – which is consistently supported by 70-80 percent of the public – will continue to use political means to advance the best interests of patients and the general public by reforming our nation’s marijuana policies.
Jag Davies is publications manager for the Drug Policy Alliance.
This is an incredibly intelligent article about the hypocrisy of Drug War officials and their obstruction of medical marijuana research. Author Jag Davies is the publications manager for the Drug Policy Alliance and a former MAPS staff member.