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Hearings Begin Today in ACLU Challenge to Government Obstruction of Medical Marijuana Research August 22, 2005 - ACLU
Scientists, Researchers and Lawmakers Demand Fairness From DEA and the Federal Government WASHINGTON - Hearings opened today in the American Civil Liberties Union's challenge to the U.S. Drug Enforcement Administration's policy of obstructing privately funded, FDA-approved scientific research that could lead to marijuana being approved as a prescription medicine.
"Despite the DEA's contentions, the public deserves and, increasingly, demands a full and fair scientific evaluation of the possible health benefits of medical marijuana," said University of Massachusetts Professor Lyle Craker, Ph.D. "As a scientist, it is my job to make plant material available for research. The DEA's refusal to permit me to grow marijuana for research necessarily prevents an accurate assessment of this plant's potential medicinal properties."
The proceedings, which are scheduled to last through the week, mark the culmination of more than four years of Professor Craker's efforts to obtain permission to produce marijuana for use in studies on the plant's medical benefits. Professor Craker, who filed his initial petition in June 2001, seeks a DEA license to grow research-grade marijuana for use in privately funded, FDA-approved studies that aim to develop marijuana into a legal, prescription medicine - an undertaking the DEA has maintained would run counter to public interest.
The U.S. Supreme Court recently held in Gonzales v. Raich that the federal government maintains authority under the commerce clause of the Constitution to enforce federal marijuana laws, even in states that have made the medical use of marijuana legal. Professor Craker's hearing before the DEA has emerged as the latest front in doctors' and patients' struggles to develop marijuana as a prescription medicine safely accessible in pharmacies.
During oral arguments last November in Raich, Justice Stephen Breyer foreshadowed current developments by suggesting that patients pursue regulatory remedies, such as asking FDA to reclassify marijuana for medical use as "the obvious way to get what they want." Justice Breyer added, "Medicine by regulation is better than medicine by referendum."
The ACLU pointed out in pre-hearing submissions to a DEA Administrative Law Judge, however, that the federal government has a clear policy of blocking administrative channels and obstructing research that could lead to the development of marijuana as a prescription medicine.
"Almost 80 percent of Americans support making medical marijuana legal, and the Supreme Court has indicated that federal regulatory agencies are the proper channel for medical marijuana patients," said Allen Hopper, a staff attorney with the ACLU Drug Law Reform Project. "All we are asking is that these agencies respond to the will of the people and the call of science. Let privately funded medical marijuana research go forward."
Through the National Institute on Drug Abuse (NIDA), the federal government currently maintains a monopoly on the supply of marijuana available for research. All other controlled substances, in contrast, are available to researchers from DEA-licensed private laboratories - including MDMA (Ecstasy), LSD, heroin and cocaine. Scientists who want to study the medical benefits of marijuana with the goal of developing it into an FDA-approved prescription medicine either cannot secure marijuana for their research or receive from the institute marijuana of insufficient quality and potency.
The ACLU's pre-hearing filings further assert that NIDA discriminates against scientists who seek to conduct research aimed at establishing marijuana's efficacy and safety as an FDA-approved prescription medicine, as such research conflicts with NIDA's mission to study only the harmful effects of drugs.
"We are frustrated with the DEA's relentless red tape and the federal government's indefensible politicization of scientific research and public wellbeing," said Rick Doblin, Ph.D., president of the non-profit Multidisciplinary Association for Psychedelic Studies, which is sponsoring Professor Craker's efforts. One of the association's primary goals is to fund research aimed at developing marijuana into a legal prescription medicine. "Drug war posturing should not be permitted to obstruct our nation's pharmaceutical development process, especially when it comes to researching a drug with well-founded potential to reduce chronic suffering."
The hearing is taking place before a Department of Justice-appointed Administrative Law Judge, who will issue recommendations to the DEA Administrator based on the hearing's findings. Such recommendations, while non-binding, nonetheless influence the DEA and are the sole administrative avenue for appealing the DEA's regulatory decisions.
In addition to Professor Craker, several other nationally renowned experts are scheduled to testify in opposition to the DEA's obstruction of marijuana research, including former senior policy analyst for the White House Office of National Drug Control Policy, Barbara Roberts, Ph.D.
Two members of the U.S. House of Representatives, John W. Olver (D-MA) and Michael E. Capuano (D-MA), have submitted a letter urging the DEA to approve Professor Craker's petition. The letter states that the government's current position "jeopardizes important research into the therapeutic effects of marijuana for patients undergoing chemotherapy or suffering from AIDS, glaucoma, or other diseases."
The ACLU is co-counsel in the case, In the Matter of Lyle Craker, with the Washington D.C. law firms Jenner & Block, LLP and Steptoe & Johnson, LLP. The pre-hearing filings, witness profiles and full background materials are available online at www.aclu.org/medicalmarijuana and at www.maps.org/mmj
THE RIGHT TO GROW - A second chance for medical marijuana? August 24, 2005 - bostonphoenix.com
Dr. Lyle Craker, a professor of plant and soil sciences at UMass Amherst, has been trying since 2001 to get a license from the Drug Enforcement Administration (DEA) to grow research-grade marijuana for use in Food and Drug Administration approved studies of the plant's potential to become a legally prescribed medicine. Last December, after more than three years of stonewalling, the DEA officially rejected his application, holding that his study "would not be consistent with the public interest."
Now Craker, along with the Belmont-based Multidisciplinary Association for Psychedelic Studies (MAPS) and the ACLU's Drug Law Reform Project, is challenging that ruling. Hearings began in Washington this week before DEA administrative-law judge Mary Ellen Bittner. Supporters hope the proceedings will end the DEA's obstruction and remove the federal government's monopoly on research marijuana.
In the wake of the Raich v. Ashcroft decision in June, in which the Supreme Court affirmed that federal law supersedes state law in matters of drug enforcement, FDA approval is really the only avenue left for medical marijuana. Before that can happen, there must be studies into its safety and efficacy. "We have considerable lay information about the potential health benefits of this plant material, but we lack the scientific studies that are necessary to prove the value of medicine," Craker told the Phoenix in December. "The first step in that is producing quality plant material that will have bioactive constituents in it."
But at the moment, all marijuana used for research in the US comes from a closely monitored crop maintained by the National Institute on Drug Abuse (NIDA). The complainants in the Craker case maintain that the supply is insufficient, and of inadequate quality, for proper research - let alone for prescription sale should the FDA ever approve it. Moreover, the feds are stingy in distributing the plants. MAPS president Rick Doblin says that just last week, NIDA refused to provide 10 grams of marijuana for a MAPS-sponsored vaporizer study at Chemic Labs in Canton.
Last month, Democratic Massachusetts representatives John Olver and Michael Capuano sent a letter to DEA administrator Karen Tandy, expressing "strong support" for issuing Dr. Craker's license and pointing out that NIDA's monopoly makes little sense since the DEA has licensed privately funded production of other Schedule I drugs, such as MDMA and LSD. (MAPS has funded studies using independently produced MDMA and psilocybin.)
"The government is basically scared of this research," says Doblin, during a break in testimony. "They want it two ways. They want to say there's not enough research to make marijuana into a medicine, and they want to block the research." Still, he feels reasonably confident that the DEA's decision might be reversed. "My sense is that the judge is fair, she's asking good questions, I have a lot of respect for the way she's interacted with us so far." Time will tell if his optimism is well-founded. There will be another week of testimony toward the end of September, and another (if need be) in December, before Judge Bittner makes a recommendation to the head of the DEA.