FDA-Approved
Medical
Marijuana
Research
Blocked
Under
New
Federal
Guidelines
12/10/99
On December 6, the U.S. Department of Health and Human Services (HHS) prevented a privately funded, FDA-approved medical marijuana study from taking place by refusing to allow the researcher to purchase marijuana from a legal source. HHS's rejection of Dr. Ethan Russo's request to purchase marijuana from the National Institute of Drug Abuse (NIDA) came just five days after HHS implemented its new medical marijuana research guidelines amidst widespread criticism that the guidelines are still "too cumbersome." Last week, a coalition of doctors, patients, medical groups, members of Congress, and other concerned citizens delivered a statement to HHS Secretary Donna Shalala, arguing that "many of the new guidelines would still be too cumbersome to enable research to move forward as expeditiously as possible." The statement was signed by Susan Sarandon, Richard Pryor, scientist Stephen Jay Gould, Ph.D., former Surgeon General Joycelyn Elders, National Review senior editor Richard Brookhiser, AIDS Action Council, New York State Nurses Association, National Black Police Association, Reagan administration official Lyn Nofziger, and hundreds of other patients, doctors, medical organizations, and concerned citizens. (The statement and a critique of HHS' guidelines are online at http://www.mpp.org/guidelines. Secretary Shalala responded to the statement last Tuesday on C-SPAN's Washington Journal, vowing to "defend" the guidelines, claiming that they enable "the kind of rigorous research that everybody else is required to do on drugs... We need to do what we do for every drug." Chuck Thomas, director of communications for the Washington, DC-based Marijuana Policy Project, charged, "In fact, the new federal guidelines actually place a much greater burden on medical marijuana researchers than on drug companies that develop and study newly synthesized pharmaceuticals. HHS proved our point by rejecting Dr. Russo's request to purchase marijuana for a privately funded, FDA-approved study. A privately funded researcher wishing to study a newly synthesized pharmaceutical would have been allowed to begin the research as soon as FDA approved the study design." "The special HHS review panel told me, via telephone, that they 'didn't like' my study, but they have yet to put their concerns in writing," said Dr. Russo, a neurologist in Missoula, Montana. "The FDA and a local Institutional Review Board had already approved my study design. That's good enough for pharmaceutical companies, so it should be good enough in my case. The Clinton administration has no business micromanaging my study after FDA approved it as is. It is to be privately funded, and I am willing to purchase the marijuana from the federal government, so there is no financial justification for requiring extra reviews. They apparently do not want to risk that clinical research will allow the FDA to approve natural marijuana as a prescription medicine."
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