Politics Trumps Science as DEA Rejects Researcher's Request to Grow Marijuana for FDA-Approved Studies

The US Drug Enforcement Administration (DEA) Wednesday blocked the years-long effort of a University of Massachusetts-Amherst researcher to end the federal government's monopoly on the supply of marijuana available for research. In doing so, the agency overruled its own Administrative Law Judge, Mary Ellen Bittner, who nearly two years ago formally recommended that the project be approved.

Lyle Craker (courtesy aclu.org/drugpolicy/)

UMass-Amherst Professor Lyle Craker initially filed a petition in June 2001 seeking to cultivate research-grade marijuana for use by researchers in Food and Drug Administration (FDA)-approved studies aimed at developing the plant as legal prescription medicine. Currently, the National Institute on Drug Abuse (NIDA) is the sole source of marijuana for researchers, but that agency has repeatedly refused to make it available for privately-funded, FDA-approved studies seeking to develop smoked or vaporized marijuana into a prescription medication. Researchers have also complained about the quality of the marijuana produced at the federal government's Mississippi pot farm.

From the beginning, Bush administration officials have been unresponsive or sought to delay the proceedings in the Craker case. The DEA first did not respond to Craker's requests for status reports on his request, then told him it had lost his filing. When he submitted a photocopy, the DEA rejected that as improper. It took until 2004 for the agency to get around to rejecting Craker's request, and ever since then for that rejection to go through the administrative appeal process.

It was during that process that DEA Administrative Law Judge Bittner made her formal recommendation supporting Craker's request: "I conclude that granting Respondent's petition would not be inconsistent with the Single Convention, there would be minimal risk of diversion of marijuana..., that there is currently an inadequate supply of marijuana available for research purposes, that competition in the provision of marijuana for such purposes is inadequate, and that the Respondent has complied with applicable laws and has never been convicted of any violation of any law pertaining to controlled substances," Bittner wrote as she weighed the factors involved in her decision. "I find there that Respondent's registration to cultivate marijuana would be in the public interest."

Judge Bittner's recommendation was based largely on the fact that marijuana is the only Schedule I drug that the DEA prohibits from being produced by private laboratories for scientific research, which has resulted in a unique government monopoly that fundamentally obstructs appropriate research and regulatory channels. Other controlled substances, including LSD, MDMA, heroin and cocaine, are available to researchers from DEA-licensed private laboratories.

In contrast, the National Institute on Drug Abuse (NIDA) remains scientists' sole source of marijuana, despite the agency's repeated refusal to make marijuana available for privately-funded, FDA-approved studies that seek to develop smoked or vaporized marijuana into a legal, prescription medicine.

As Judge Bittner concluded, "NIDA's system for evaluating requests for marijuana has resulted in some researchers who hold DEA registrations and requisite approval from [HHS and FDA] being unable to conduct their research because NIDA has refused to provide them with marijuana. I therefore find that the existing supply is not adequate."

But just as was the case with DEA Administrative Law Judge Francis Young's famous 1988 recommendation that marijuana was among the safest therapeutically active substances known to man and should be rescheduled, Bittner's recommendation was also ignored by her own agency. In the final decision issued this week, the DEA simply rejected most of Bittner's findings, and rejected Craker's petition.

"I am saddened that the DEA is ignoring the best interests of so many seriously ill people who wish for scientific investigations that could lead to development of the marijuana plant as a prescription medicine," said Professor Craker. "Patients with serious illnesses deserve legitimate research that might establish medical marijuana as a fully legal, FDA-approved treatment. Today, that effort has been dealt a serious blow."

Craker wasn't the only one protesting. The ACLU Drug Law Reform Project, the Marijuana Policy Project (MPP), and the Multidisciplinary Association for Psychedelic Studies (MAPS) all supported Craker's quest, and all blasted the DEA decision.

"It's no surprise that an administration that has rejected science again and again has, as one of its final acts, blocked a critical research project," said MPP director of government relations Aaron Houston. "With the new administration publicly committed to respecting scientific research and valuing data over dogma, this final act of desperation isn't surprising, but the true victims are the millions of patients who might benefit."

"With one foot out the door, the Bush administration has once again found time to undermine scientific freedom," said Allen Hopper, litigation director for the ACLU Drug Law Reform Project. "In stubbornly retaining the unique government monopoly over the supply of research marijuana over the objections of DEA's own administrative law judge, the Bush administration has effectively blocked the proper regulatory channels that would allow the drug to become a wholly legitimate prescription medication."

"The DEA and NIDA, but not the FDA, are clearly frightened of permitting privately-funded, scientific research into the risks and benefits of the medical uses of marijuana," said Rick Doblin, president of MAPS. "We need the Obama Administration to reverse this egregious suppression of scientific research that the outgoing administration so fears will reveal inconvenient truths."

Despite the DEA rejection, these are the waning days of the Bush administration, and this isn't over yet. Look for another lawsuit or an appeal to the Obama administration, said Doblin.