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Defending Patients’ Access to Medical Marijuana
Volume 3, Issue 2
ASA Files Challenge to Misinformation On Medical Cannabis
The federal government's continuing denials of the medical efficacy of cannabis may soon come to an end, thanks to action by Americans for Safe Access. On February 21, ASA filed a lawsuit in federal court demanding that the Food and Drug Administration and the Department of Health and Human Services stop spreading misinformation on medical cannabis and correct the information they have published. "The FDA position on medical cannabis is incorrect, dishonest and a flagrant violation of laws requiring the government to base policy on sound science," said Joe Elford, Chief Counsel for ASA. The ASA lawsuit charges the federal agencies with a violation of the little-known Data Quality Act (DQA). That law requires federal agencies to rely on sound science in the information they disseminate and the policies they make. The DQA also allows citizens to challenge government information believed to be inaccurate or based on faulty, unreliable data. The ASA case specifically challenges the government position that "marijuana has no accepted medical value." "The science to support medical cannabis is overwhelming, yet the government contin-
ASA staff and one of the named patients in front of the federal courthouse in Oakland after filing the HHS lawsuit. L-R Rebecca Saltzman, William Dolphin, Joe Elford, Delisa Jones, Steph Sherer, Jacqueline Patterson, Kris Hermes, Noah Mamber.
ues to play politics with the lives of patients desperately in need of pain relief," said ASA Executive Director Steph Sherer. "Americans for Safe Access is filing this lawsuit on medical cannabis to demand that the FDA stop holding science hostage to politics." The court filing is the outcome of a more than two-year petition process and comes on the heels of a recent University of
California, San Francisco study demonstrating the effectiveness of medical cannabis in treating pain in people living with HIV/AIDS.
Judge Says Grow Research Cannabis
In what may be a significant breakthrough for U.S. researchers, who have been largely thwarted by government restrictions, an administrative law judge for the DEA has concluded that more cannabis research is "in the public interest" and that the government's supply of cannabis is inadequate. On February 12, Judge Mary Ellen Bittner issued a ruling in favor of University of Massachusetts-Amherst Professor Lyle E. Craker, Ph.D., who has led a six-year struggle to gain a DEA license to grow researchgrade cannabis. Prof. Craker hopes to conduct clinical studies that will determine the full extent of marijuana's medical value. The DEA's response to the ruling is due March 26; Prof. Craker will have until May 4 to answer. The DEA Deputy Administrator will then decide whether to accept or reject the ruling, likely within three to 15 months.
Advocacy Groups Join ASA in Calling for Congressional Hearings
A new study demonstrating the effectiveness of cannabis in alleviating nerve pain for HIV patients has patient advocacy groups calling for Congressional hearings. Americans for Safe Access joined with national HIV/AIDS and advocacy groups in appealing for new policies on cannabis. The study, conducted at the University of California, San Francisco medical school and published February 12 in the peer-reviewed journal Neurology, showed that HIV patients suffering from neuropathic pain, a notoriously harsh and difficult to treat condition, reported twice as much relief from cannabis as compared to a control group. "This study validates the experience people living with HIV/AIDS and their doctors have reported for years- medical cannabis provides much-needed relief from pain and suffering." said Frank Oldham Jr., the executive director of the National Association of People With AIDS. "That is why we are joining Americans for Safe Access to call on Congress to address cannabis for its medicinal value." An estimated 3-4 million people in the U.S. suffer from neuropathic pain, and as many as 37% of people living with HIV/AIDS use
Americans for Safe Access • 1322 Webster Street, Suite 402 • Oakland, CA 94612 510-251-1856 • info@AmericansForSafeAccess.org • www.AmericansForSafeAccess.org
FALSE INFO CHALLENGED, continued)
AMERICANS FOR SAFE ACCESS
www.AmericansForSafeAccess.org 1322 Webster Street, #402 Oakland, California 94612 Phone: 510-251-1856 Fax: 510-251-2036 info@AmericansForSafeAccess.org
(RESEARCH UPDATE, continued)
treating pain in people living with HIV/AIDS. ASA first filed a petition to force HHS - the FDA's parent agency - to correct statements about the medical value of cannabis in October 2004. Under the DQA, agencies must respond or file for an extension 60 days from the date of the first petition filing. The government response was a statement saying that it would not act on the petition, a position it has maintained despite ASA's May 2005 appeal. Using the DQA's judicial review provisions, the Oakland-based organization is now taking its cause to the courts. "Citizens have a right to expect the government to use the best available information for policy decisions. This innovative case turns the Data Quality Act into a tool for
the public interest," said case co-counsel Alan Morrison, a preeminent legal scholar who founded Public Citizen's Litigation Group and currently serves as a senior lecturer at Stanford Law School. "I had side effects from morphine patches, oxycontin, and oxycodone before starting a medical cannabis regime that has allowed me to get off prescription drugs and live virtually pain-free," said Blackfoot, Idaho resident Victoria Lansford, a named patient in the lawsuit who suffers from fibromyalgia. "The government's refusal to face up to the science is irresponsible and harms citizens like me for whom this treatment is a lifeline." The DQA complaint ASA filed in court is at: AmericansForSafeAccess.org/downloads/DQ A_Complaint.pdf. DQA Background info: AmericansForSafeAccess.org/DQA.
ASA scientific director Barbara Roberts, Ph.D., a former head of the Office of National Drug Control Policy, called publication of the neuropathy study and Bittner's decision a double blow to those who would prohibit such research. "The government wants to have it both ways: they say the study doesn't have scientific rigor, so therefore there is no point in going forward. And, by the way, we are not allowing the science to go forward either," she said. Roberts said Congress should hold hearings" on the 1999 IOM report that supported research into the medicinal potential of marijuana. Download the judge's 87-page ruling at AmericansForsafeAccess.org/downloads/Cra ker_Ruling.pdf
(CALL FOR HEARINGS, continued)
cannabis to treat neuropathy and other symptoms associated with the disease. The UCSF study was a randomized, placebocontrolled clinical trial of 50 patients who had an average of six years of neuropathic pain. The pain reduction in the group receiving the medical cannabis was twice that of those using a placebo. "I have been living with HIV/AIDS for 21 years and owe my life to the benefits of medical cannabis," said UCSF study participant Diana Dodson. "It reduces the pain and side-effects such as nausea and stomach pains that are caused by the drugs I need to take in order to stay alive. But I need the government to grant me safe access to my medicine." The study adds to the scientific evidence accumulated by researchers outside the U.S. and a 1999 Institute of Medicine (IOM) report, Marijuana and Medicine, Assessing the Science Base, which concluded that there are patients and conditions for which cannabis is the best treatment. "This study demonstrates the potential effectiveness of medical cannabis to treat
the chronic pain of people living with HIV/AIDS," said Dr. Barbara T. Roberts, Director of Medical and Scientific Affairs for Americans for Safe Access and a former Senior Policy Analyst at the White House Office of National Drug Control Policy, which commissioned the IOM report. "In addition to people living with HIV/AIDS, there are thousands of vets returning from Iraq who will spend decades coping with neurological pain," Dr. Roberts said. "By implementing the recommendations of the IOM report, the federal government would be exploring more options for their longterm treatment of neuropathic pain." The groups are calling on Congress to hold hearings on the IOM report to adopt its recommendations to allow patients and researchers to have access to medical cannabis. "It's time for Washington to stop playing politics with patients' lives and advance this important scientific discovery," said Steph Sherer, Executive Director of Americans for Safe Access. "The study is a wake-up call for Congress to hold hearings to investigate therapeutic use and encourage research."
Clinical Study Shows Cannabis Effective for Patients with Neuropathic Pain
For the first time in nearly 20 years, a U.S. researcher has been able to publish the findings of a clinical study of therapeutic cannabis. The study, conducted by Dr. Donald Abrams of the University of California San Francisco medical school, found that HIV/AIDS patients suffering from neuropathic pain got twice as much relief from cannabis as compared to a control group. The randomized placebo-controlled trial involved 50 patients who were randomly assigned to smoke either cannabis (3.56% tetrahydrocannabinol) or identical placebo cigarettes with the cannabinoids extracted three times daily for 5 days. Smoked cannabis reduced daily pain by 34% (median reduction; IQR = -71, -16). Greater than 30% reduction in pain was reported by 52% in the cannabis group and the first cannabis cigarette reduced chronic pain by a median of 72% vs. 15% with placebo. Researchers concluded that smoked cannabis was well tolerated and effectively relieved chronic neuropathic pain from HIVassociated sensory neuropathy. The abstract and full article can be seen at http://neurology.org/cgi/content/abstract/68/7/515.
N AT I O N A L A C T I O N A L E R T
Call on Congress to Hold Hearings on Medical Cannabis
In light of long overdue research published recently in Neurology, ASA is asking Congress to support our call for congressional oversight hearings to investigate why federal agencies resist full implementation of the recommendations provided by the Institute of Medicine in their 1999 report, Marijuana and Medicine: Assessing the Science Base. E-mail your Senators and Representative and urge support for congressional hearings to investigate why federal agencies discourage medical cannabis research. Visit ASA's congressional action site to send your letter: www.AmericansForSafeAccess.org/CongressionalHearings or call the Congressional Switchboard at (202) 224-3121 to reach your representative.
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