April 15, 2007.
OPED: Rejected in Court, Medical Pot Advocates Turn to DEA
Published on Sunday 15 April, 2007
in the Sacramento Bee
Author: Claire Cooper
REJECTED IN COURT, MEDICAL POT ADVOCATES TURN TO DEA
A federal appeals court's rejection of Angel Raich's plea for permission to ease her suffering without fear of prosecution has medical marijuana advocates looking for reform in a surprising venue - -- the Drug Enforcement Administration.
Raich's loss severely diminishes prospects of reform through litigation. But a February "opinion and recommended ruling" by a DEA administrative law judge holds out the possibility that prescription marijuana will be developed and approved by the Federal Drug Administration, ending the long federal-state standoff over medical pot.
Mary Ellen Bittner, a Department of Justice appointee who hears regulatory cases for the DEA, tentatively ruled it "would be in the public interest" to let Lyle E. Craker, a medicinal plant specialist at the University of Massachusetts, Amherst, grow pot for use by DEA-registered scientists in prescription drug research and clinical trials authorized by the FDA.
If Bittner's ruling becomes final, it could punch a hole in the wall that federal agencies -- the DEA and the National Institute on Drug Abuse -- have erected around legal marijuana, stymieing research into an effective, legal pharmaceutical. Doctors could be prescribing pot as easily as methadone, codeine or morphine, perhaps in seven or eight years.
That would be a long time for Raich, whose serious ailments include an inoperable brain tumor, and for other people who depend on marijuana to stay alive or ease the pain of dying. But it would be a short time in the myth-driven history of marijuana regulation that began in the United States with the Marihuana Tax Act of 1937. Passage of the Controlled Substances Act in 1970 imposed a ban on pot production, distribution and use that remains almost absolute because of the federal government's stubbornly held position that pot poses extreme risks and has no proven medical value.
Evidence to the contrary has been building. In 1999, the Institute of Medicine of the National Academy of Sciences reported that most regulatory concerns could be overcome by developing marijuana delivery systems, such as vaporization, that should avoid the lung damage caused by smoking. As recently as two months ago researchers reported that HIV-positive patients at San Francisco General Hospital who smoked marijuana found relief from searing pain in their hands and feet. Other studies have shown that pot can stimulate appetite and reduce nausea and muscle spasticity.
Yet as Bittner noted, scientists have been winning federal approval to conduct promising medical marijuana research projects only to be denied access to the sole legal pot supply in the country, grown for NIDA at the University of Mississippi. NIDA specifies how much shall be grown each year. The professor in charge in Mississippi testified in 2005 that he had grown no marijuana for three years because he had enough inventory to cover research needs.
California researchers have received pot produced in Mississippi for use in state-authorized safety and efficacy studies, but they are not developing a prescription drug. John Vasconcellos, the former state senator whose legislation established the University of California Center for Medical Cannabis Research, testified before Bittner that the purpose was not to get FDA drug approval but "to demystify the roaring contentions of contrary viewpoints and to find out by science . whether in fact (marijuana is) of any use."
Bittner concluded that more research-grade pot is needed and that competition to supply it is inadequate. She will make her final recommendation to the DEA -- which will have the last word -- on the basis of comments submitted by lawyers for the DEA and for Craker.
A final recommendation in favor of Craker almost certainly would have been doomed in years past and may still be. The Multidisciplinary Association for Psychedelic Studies, which would fund research, estimates chances of success at one in three. But medical pot advocates vow to make a strong push for support from the new Congress, where the atmosphere for marijuana reform should be more hospitable than it's been in a long time. Although the lobbyists don't expect a major drug law overhaul before the 2008 elections, they see friends in key leadership positions.
Among those listed in a recent article by Bill Piper, director of national affairs for the Drug Policy Alliance, are Ohio Democrat Dennis Kucinich, chairman of the House Government Reform and Oversight Committee, which oversees the White House drug czar's office, the coordinator of national drug control policy. Kucinich has gone on record in support of removing medical pot users from the criminal justice system. Piper also pointed to Michigan Democrat John Conyers, the new chairman of the House Judiciary Committee; Virginia Democrat Robert C. Scott, chairman of the House Subcommittee on Crime; and Wisconsin Democrat David Obey, chairman of the House Appropriations Committee. Even in 2006, when putting pressure on the DEA had to be taken as a futile gesture, 163 members of the House voted to end federal raids on patients complying with their states' medical marijuana laws.
By contrast, prospects for reform through the courts look dimmer than at any other time since California passed the nation's first Compassionate Use Act in 1996.
The ruling last month against Raich by the 9th U.S. Circuit Court of Appeals, the nation's most progressive federal appellate court, seems to close the door to the strongest common-law and constitutional arguments for peaceful coexistence of the state and federal marijuana regulatory schemes.
The 9th Circuit ruled on several grounds.
Though the judges didn't doubt Raich's suffering -- the Oakland woman has regularly appeared in their courtroom looking X-ray thin -- they rejected an argument that federal authorities should be enjoined from busting her because her marijuana use is a medical necessity. If the DEA does prosecute her, that would be the time to assert her medical necessity defense, the judges said.
They also ruled that Raich has no fundamental due-process right to use marijuana "to avoid intolerable pain and preserve life and bodily integrity," though they predicted legal recognition of such a right once more states pass medical marijuana laws. New Mexico's legislature approved a medical marijuana law the day before the 9th Circuit issued its decision, making that state the 11th to follow California's lead.
The 9th Circuit also found that California has no 10th Amendment right as a sovereign state to have its own marijuana laws prevail over conflicting federal law.
The 10th Amendment argument isn't quite dead yet. It's now being asserted by the city of Santa Cruz as a plaintiff in federal court in San Jose. The city may have a stronger case because its own ordinance authorizes it to provide marijuana to its residents who qualify to use the drug under the state law.
However, the U.S. district judge in the Santa Cruz case is Jeremy Fogel, a by-the-book jurist who's not likely to adopt a novel legal theory. The Santa Cruz case had been on hold pending the Raich decision and soon will move toward resolution.
Finally, the 9th Circuit's opinion held out a possibility that medical pot users could claim an exemption from federal penalties under the "plain language" of the Controlled Substances Act. For the time being that's probably a meaningless concession.
The federal statute permits possession of a controlled substance if it's obtained "pursuant to a valid prescription or order" by a physician. But "order" has been interpreted to mean "prescription," and the federal government doesn't let doctors prescribe pot. Under California's Compassionate Use Act, the state's doctors can only "recommend" it to qualifying patients.
This is where Craker comes in. Pot grown by him would be subsidized by the Multidisciplinary Association for Psychedelic Studies, a nonprofit pharmaceutical company that would sponsor the development of marijuana as a prescription medicine within the framework of the FDA drug approval process. The research likely would include pot vaporization studies that MAPS has been trying to get under way for at least four years.
FDA approval of a marijuana drug that doctors can prescribe seems to be no pipe dream. While the agency has opposed state medical marijuana laws as premature, its official position for several years has been to encourage research needed to take a marijuana drug through the approval process.
Robert Meyer, head of the FDA's Office of Drug Evaluation II, testified in 2004 congressional hearings that his agency and its parent Department of Health and Human Services "recognize the need for objective evaluations of the potential merits of cannabinoids (the 66 compounds unique to pot) for medical uses."
"If the scientific community discovers a positive benefit," said Meyer, "HHS also recognizes the need to stimulate development of alternative, safer dosage forms."
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Medical pot advocates turn to DEA