NIDA Blocks Marijuana Vaporization Study Sponsored by California NORML, MAPS

Medical Marijuana Research Advocates Appeal for Redress at DEA Hearings

California NORML Press Release - August 25, 2005

After 18 months of regulatory delay, a laboratory study of marijuana vaporization sponsored by MAPS and California NORML has been blocked by the US Public Health Service/ National Institute on Drug Abuse (NIDA). NIDA made it known that it was rejecting the laboratory's application to buy 10 grams of research marijuana just days before the opening of DEA hearings on an application by Prof. Lyle Craker of the University of Massachusetts to license an independent marijuana production facility for use in FDA-approved medical marijuana R&D sponsored by MAPS (Multidisciplinary Association for Psychedelic Studies).

Because NIDA controls the only legal supplies of marijuana in the U.S., its refusal effectively prevents the vaporizer study from proceeding. For purposes of comparison, the laboratory had also sought a DEA permit to import a few more grams of marijuana from a government-licensed manufacturer in the Netherlands, the only other legal foreign supplier available. The DEA has never approved importation of foreign medical marijuana. After 18 months of delay, the DEA has yet to make its decision known, but it is now expected to follow NIDA's lead and deny the import permit.

The vaporization study is aimed at developing a smokeless delivery system for medical marijuana patients. Previous studies have indicated that vaporization can deliver medically active cannabinoids while eliminating the toxic byproducts of smoke by heating marijuana to a temperature just short of combustion. Because of concern over the dangers of smoked medicine, the development of vaporization is viewed as an essential step to obtaining FDA approval of marijuana as medicine. In its 1999 report, "Marijuana and Medicine," the Institute of Medicine concluded that there was little future in smoked marijuana and so recommended that research be conducted into "developing rapid-onset, reliable, and safe delivery systems."

"Once again, the government has displayed its bad faith by creating a Catch-22 for medical marijuana," commented California NORML coordinator Dale Gieringer, one of the sponsors of the study. "First, it claimed that marijuana couldn't be used as a medicine because there weren't sufficient FDA studies of safety and efficacy. Then it refused to provide marijuana to conduct the studies. Then it contended that marijuana was inappropriate for FDA approval in the first place due to the dangers of smoking. Now it is blocking the very studies called for by the IOM to develop non-smoked alternatives to smoking."

In its rejection letter, NIDA indicated that the proposed vaporization study lacked scientific merit. Researchers reply that NIDA's reasons are bogus and display a basic misunderstanding of the study. "NIDA could have easily cleared up any questions they had with a simple phone call, rather than sitting on the application a year and a half and issuing a politically motivated rejection letter," says Gieringer.

At the DEA hearings, a former Office of National Drug Control Policy deputy, Dr. Barbara Roberts, testified that NIDA had been under orders from the drug czar's office not to allow approval of smoked marijuana. Roberts said she originally proposed the IOM study as a way of giving then-Drug Czar Barry McCaffrey "a way out" of the increasingly heated public controversy over medical marijuana. She said the IOM's conclusions were not what the agency had expected, and so nothing was done to follow up and implement them.

Hearings at DEA Headquarters

The hearings were held Aug. 22 ≠ 26 at the DEA's headquarters in Pentagon City, Virginia, before administrative law judge Mary Ellen Bittner. Bittner is the successor and former protÈgÈe of the late Francis Young, who presided over the marijuana rescheduling hearings in 1988. Young ruled that marijuana clearly had "accepted medical use" and should accordingly be reclassified as a Schedule II prescription drug. DEA Administrator Jack Lawn subsequently overruled Young's decision by issuing new regulations redefining "accepted medical use" to require prior FDA approval. Bittner's task is to decide whether granting Prof. Craker's application for a DEA license to manufacture marijuana would be in the public interest as specified in 21 USC 823(a). It remains to be seen whether DEA can concoct a way to redefine public interest in the event Judge Bittner rules against it.

Prof. Craker, a professor of Plant and Soil Sciences at U Mass Amherst, is an expert on the cultivation of medicinal plants. Prof. Craker testified that he had no prior experience with marijuana, but had been contacted by Rick Doblin to apply for a DEA license to manufacture it legally for use in approved FDA research sponsored by MAPS. MAPS has obtained an FDA orphan drug designation to develop marijuana as a prescription drug for AIDS wasting syndrome. However, NIDA has repeatedly refused to allow its marijuana to be used by MAPS and other researchers, effectively blocking medical marijuana research For this reason, advocates contend that an independent, non-NIDA source of supply is needed to break the government stranglehold on research.

At the hearings, advocates countered the government's claim that it has already made adequate provision for medical marijuana research by allowing marijuana to be provided to a series of studies at the California Center for Medicinal Cannabis Research. Speaking as a member of the CMCR's advisory council, Dale Gieringer testified that the CMCR's studies were neither designed nor intended to advance FDA approval of marijuana, but simply to answer basic questions about safety and efficacy outlined in its implementing legislation. He explained that it would be necessary for the state to establish its own source of marijuana independent of NIDA in order to pursue new drug approval, and that there were no plans or resources to do so. The CMCR has some 15 clinical studies currently in progress, two of which are finally nearing publication. However, even if all were complete, they would not constitute the kind of evidence necessary to win FDA approval.

Former state Sen. John Vasconcellos, the author of the legislation establishing CMCR, noted that $9 million had been appropriated to the CMCR's research budget, and that money had already been fully committed to ongoing studies. He opined that further appropriations were highly unlikely in light of the state's massive $40 billion budget deficit. DEA attorney Imelda Paredes tried to smear Vaconcellos with an ad hominem attack. She noted that he is listed in a recent (right-wing) best seller, "One Hundred People Who Are Screwing Up America," and ridiculed his famous California panel for self-esteem, which she claimed had been scientifically discredited. Vasconcellos forcefully repelled the attack, saying he was proud to be listed in the book along with President Jimmy Carter, and berating Paredes' evident ignorance of the scientific literature on self-esteem.

Petitioners presented evidence that NIDA's marijuana was of inferior quality for medical purposes. They cited reports that NIDA's pot was contaminated by stems and seeds, harsh to smoke, and of much lower potency than the medical sinsemilla commonly sold at cannabis clubs, so that subjects had to inhale more smoke to obtain the same effective dose. Doblin cited the experience of an AIDS patient, Philip Alden, who had enlisted in a CMCR study using NIDA pot after several years' experience smoking marijuana from California's cannabis clubs. Alden found that smoking NIDA's pot caused him to develop bronchitis for the first time in his life. The bronchitis disappeared after he dropped out of the study and returned to smoking the clubs' marijuana.

Alden was one of several witnesses who had originally been scheduled to testify but withdrew out of fear of possible legal repercussions. Another medical marijuana patient, Irvin Rosenfeld, also dropped out on advice of his attorney. Patients were apparently concerned about being forced to testify about use of non-NIDA medical marijuana, which, though legal in many states, remains illegal under federal law. Numerous other, scientific witnesses declined to testify publicly out of concern that their research activities might be imperiled by DEA or NIDA.

Their fears were highlighted by a nasty turn in the DEA's tactics during the third day of the hearings, which had hitherto been marked by a degree of relaxed cordiality under the good-humored guidance of Judge Bittner. DEA attorneys bore down on Doblin in the cross-examination, trying unsuccessfully to get him to disclose the names of patients who had been involved in research projects that had skirted DEA regulatory restrictions. Finally, DEA attorney Brian Bayly zeroed in on Doblin himself, asking whether he had ever smoked marijuana for recreational use. Over the strenuous objection of Doblin's attorney, Judge Bittner ruled that she would admit the question and decide later whether it was relevant. Doblin answered with a forthright "Yes." Bayly bore down further, asking Doblin to tell when, how often, and how recently he had smoked marijuana. He replied that he used it weekly. The judge finally halted the inquisition when Bayly asked Doblin to tell the source of his marijuana. Doblin says he is glad to have answered honestly and hopes that it will not prejudice the judge's decision.

Doblin was ably represented by attorney Julie Carpenter of Jenner and Block with assistance by Allen Hopper of the ACLU. A second round of hearings is scheduled the week of Sept. 26th.

Full transcript of the DEA hearings may be found at: http://www.maps.org/mmj/legal/craker-dea/transcript0824.html

Report by Dale Gieringer, California NORML 8/25/05