Pubdate: Thur, 18 Feb 1999 Source: PR Newswire Copyright: 1999 PR Newswire AIDS GROUPS ISSUE FIRST CALL FOR DRUG CZAR TO APPROVE MEDICAL MARIJUANA ON FAST TRACK FOR PEOPLE WITH AIDS Unprecedented Statement Comes as Institute of Medicine Prepares to Publish Full Review of Medical Marijuana Science WASHINGTON, Feb. 18 /PRNewswire/ -- Physicians should be allowed to prescribe marijuana as an emergency measure to people with HIV/AIDS without further research, says a letter to be sent February 17th from the heads of seventeen AIDS organizations to General Barry McCaffrey, director of the Office for National Drug Control Policy. This is the first time that AIDS groups have come together to call for legal, immediate access to marijuana. Citing a fast-track system that has allowed physicians to prescribe protease inhibitors and other AIDS medications before the completion of clinical trials, the letter calls on McCaffrey to give immediate approval to what they say is another life-saving drug -- marijuana. "We urge you to help break the bureaucratic logjam that is keeping a potentially life-saving medicine, marijuana, virtually inaccessible to thousands of people living with AIDS," says the letter, signed by AIDS Action Council, San Francisco AIDS Foundation, Latino Commission on AIDS, National Native American AIDS Prevention Center, AIDS National Interfaith Network, Mothers' Voices to End AIDS, AIDS Project Los Angeles, and other organizations around the country. Copies of the letter were also sent to the Secretary of Health and Human Services, the Director of the U.S. Food and Drug Administration, the Office of National AIDS Policy and the U.S. House and Senate Majority and Minority leaders. The AIDS organizations are urging McCaffrey to make good on an October, 1997 statement to Congress, which said: "If sound medical research demonstrates that there are medical uses for smoked marijuana, there are appropriate and responsive procedures for rescheduling this mind-influencing drug through the time-tested process. "The FDA has already demonstrated flexibility in accelerating procedures for allowing the use of emerging AIDS-related drugs without jeopardizing science or the public health." Thousands of Americans with HIV/AIDS use marijuana to relieve the nausea caused by multiple-drug therapies, and to combat the "wasting syndrome" associated with the late, often fatal, stages of AIDS by stimulating appetite. But, with marijuana classed as a highly-controlled Schedule I substance under federal law, most patients use the medicine illegally, risking prosecution and exposure to contaminated products. Recent studies and editorials in prestigious scientific journals Lancet, New Scientist, New England Journal of Medicine and the Journal of the American Medical Association have concluded that marijuana's medical benefits outweigh its risks. Convinced by existing research, Britain and Israel recently sanctioned the compassionate use of marijuana on a provisional basis, and six U.S. states have passed ballot initiatives to legalize medical marijuana -- throwing state policies into conflict with federal law. In 1996, McCaffrey commissioned the Institute of Medicine at the National Academy of Sciences to conduct a full review of the science surrounding medical marijuana. That study is expected to be released next month, and may lead to calls for new research into medical marijuana. Just one clinical trial has been approved by the federal government since 1985. AIDS organizations say terminally-ill patients cannot afford to wait for years of research to prove something they already know: medical marijuana works. "Science and compassion should dictate our nation's policy regarding medical treatment," says the letter. "However, politics has stood in the way of the approval of marijuana as a legal medication, and the full development of a science base leading to FDA approval could still be years away. "Under these circumstances, making marijuana immediately available on a quasi-experimental basis to people living with AIDS [...], is a moderate step that can add to the federal government's responsiveness to the epidemic." (The full text of the letter follows:) February 17, 1999 General Barry McCaffrey Director Office of National Drug Control Policy Dear General McCaffrey; As advocates and care givers for people living with HIV disease and AIDS, we are writing to urge you to help break the bureaucratic logjam that is keeping a potentially life-saving medicine virtually inaccessible to thousands of people living with AIDS and other debilitating illnesses. That medicine is marijuana. Marijuana's therapeutic uses are well documented in scientific literature. Recent scientific studies have confirmed what has been reported to us by hundreds of people living with HIV -- that marijuana can be safely used to reduce nausea and vomiting, stimulate appetite, and promote weight gain. Marijuana is widely recognized by physicians specializing in AIDS care as an important component of treatment for some patients who suffer from symptoms of advanced-stage HIV disease and the multiple-drug therapies used to manage HIV. Today, thanks to one federally approved clinical study of marijuana for people living with AIDS, sixty-four patients receive marijuana legally from supplies grown by the federal government. However, thousands of Americans, many of them people living with HIV, use marijuana as a medicine illegally, putting themselves at risk of arrest and prosecution. Because the practice is illegal, most patients use marijuana without medical supervision. Marijuana's illegality means that patients cannot be sure of obtaining standardized products that are free of contaminants. People should not have to risk their health or jail to receive needed medical care. For this reason, thirty-five state legislatures have passed laws supporting the use of marijuana as a medicine. In addition, voters in six states (Alaska, Arizona, California, Nevada, Oregon, and Washington) and the District of Columbia have recently approved ballot measures legalizing the medical use of marijuana within their borders -- nearly one in five Americans lives in a state whose voters have approved medical marijuana. Now, the nation is looking to the federal government to begin to show compassion and flexibility on this issue. You may be aware that the standard Food and Drug Administration approval process has been streamlined for several medications important to people living with HIV disease and AIDS. Drugs shown to fall within an acceptable standard of safety have been made available to patients before completion of all scientific trials proving effectiveness. This special procedure has helped thousands of patients to obtain life-extending benefits from new medications, and has contributed directly to building the science base for such new drugs. Our request is simple. Just as other promising AIDS medications have been made available prior to final FDA approval, so too should marijuana, when recommended by a physician, be made available to patients who choose to use it. There is not much question about the relative safety of marijuana -- it has been heavily studied around the world. These studies have revealed an important fact: there is no lethal dose of marijuana. Besides this finding, occasional marijuana smoking under controlled circumstances has not been proved to be dangerous. In sum, the known risks of marijuana are clearly within a range of acceptability sufficient to allow individual physicians and patients to monitor its use, and its results. Under these circumstances, making marijuana immediately available on a quasi-experimental basis to people living with AIDS, when their physicians request it, is a moderate step that can add to the federal government's responsiveness to the epidemic. We appeal to you, General McCaffrey, because you are in a unique position to provide leadership on this issue. Science and compassion should dictate our nation's policy regarding medical treatment. However, politics has stood in the way of the approval of marijuana as a legal medication, and the full development of a science base leading to FDA approval could still be years away. We call upon you to be a part of the political solution. We ask that you publicly encourage your colleagues in the administration to respond positively to the scientific and public support for making marijuana medically available. Sincerely, cc: Donna Shalala, Secretary of Health and Human Services* Jane Henney, director, Food and Drug Administration* Sandra Thurman, director, Office of National AIDS Policy* Sen. Trent Lott (R-MS) Senate Majority Leader* Sen. Tom Daschle (D-SD) Senate Minority Leader* Rep. J. Dennis Hastert (R-IL), Speaker of the House* Rep. Dick Armey (R-TX) House Majority Leader Rep. Richard Gephardt (D-MO) House Minority Leader SIGNATORIES * Daniel Zingale/Jeff Jacobs Executive Director/Legislative Director AIDS Action Council * Regina Aragon Public Policy Director San Francisco AIDS Foundation * Herb K. Schultz Director of Government Affairs AIDS Project Los Angeles * Martin Ornelas-Quintero National Latina/o Lesbian, Gay, Bisexual and Transgender Organization Washington, DC * Julian B. Rush United Methodist Minister / Colorado AIDS Project Denver, CO * Mary Margaret Bush Executive Director The Center for AIDS Services Oakland, CA * Donna Rae Palmer Executive Director Mobilization Against AIDS San Francisco, CA * Matt Patrick Executive Director Boulder County AIDS Project Boulder, CO * Kenneth T. South Executive Director AIDS National Interfaith Network Washington, D.C. * Ron Rowell Executive Director National Native American AIDS Prevention Center Oakland, CA * Chris Norwood Health Force: Women and Men Against AIDS Bronx, NY * Dennis de Leon Latino Commission on AIDS New York, NY * David E. Munar Director of Public Policy AIDS Foundation of Chicago Chicago, IL * Trish Moyan Torruella Executive Director Mothers Voices to End AIDS New York, NY * Dr. Pat Hawkins Associate Executive Director Whitman-Walker Clinic Washington, DC * Steven B. Johnson Director of Public Policy and Communications Northwest AIDS Foundation Seattle, WA * Mark D. Garvey Being Alive Program Specialist AIDS Project Arizona Phoenix AZ * Lupe Lopez Executive Director People of Color Against AIDS Network Seattle, WA CONTACT: Rachel Swain, Senior Publicist of Communication Works, 415-255-1946. - --- MAP posted-by: Don Beck