F.D.A. Dismisses Medical Benefit From Marijuana
Published:
April 21, 2006 WASHINGTON, April 20 — The Food
and Drug Administration said Thursday that "no sound
scientific studies" supported the medical use of marijuana,
contradicting a 1999 review by a panel of highly regarded scientists. The announcement inserts the health agency into yet another
fierce political fight. Susan Bro, an agency spokeswoman, said Thursday's statement
resulted from a past combined review by federal drug enforcement,
regulatory and research agencies that concluded "smoked marijuana
has no currently accepted or proven medical use in the United States
and is not an approved medical treatment." Ms. Bro said the agency issued the statement in response to
numerous inquiries from Capitol Hill but would probably do nothing to
enforce it. "Any enforcement based on this finding would need to be
by D.E.A. since this falls outside of F.D.A.'s regulatory
authority," she said. Eleven states have legalized medicinal use of marijuana, but
the Drug Enforcement Administration and the director of national drug
control policy, John P. Walters, have opposed those laws. A Supreme Court decision last year allowed the federal
government to arrest anyone using marijuana, even for medical purposes
and even in states that have legalized its use. Congressional opponents and supporters of medical marijuana
use have each tried to enlist the F.D.A. to support their views.
Representative Mark Souder, Republican of Indiana and a fierce
opponent of medical marijuana initiatives, proposed legislation two
years ago that would have required the food and drug agency to issue
an opinion on the medicinal properties of marijuana. Mr. Souder believes that efforts to legalize medicinal uses
of marijuana are a front for efforts to legalize all uses of it, said
Martin Green, a spokesman for Mr. Souder. Tom Riley, a spokesman for Mr. Walters, hailed the food and
drug agency's statement, saying it would put to rest what he called
"the bizarre public discussion" that has led to some
legalization of medical marijuana. The Food and Drug Administration statement directly
contradicts a 1999 review by the Institute of Medicine, a part of the
National Academy of Sciences, the nation's most prestigious scientific
advisory agency. That review found marijuana to be "moderately
well suited for particular conditions, such as
chemotherapy-induced
nausea and vomiting and AIDS
wasting." Dr. John Benson, co-chairman of the Institute of Medicine
committee that examined the research into marijuana's effects, said in
an interview that the statement on Thursday and the combined review by
other agencies were wrong. The federal government "loves to ignore our
report," said Dr. Benson, a professor of internal medicine at the
University of Nebraska Medical Center. "They would rather it
never happened." Some scientists and legislators said the agency's statement
about marijuana demonstrated that politics had trumped science. "Unfortunately, this is yet another example of the
F.D.A. making pronouncements that seem to be driven more by ideology
than by science," said Dr. Jerry Avorn, a medical professor at
Harvard Medical School. |
Representative Maurice D. Hinchey, a New York Democrat who
has sponsored legislation to allow medicinal uses of marijuana, said
the statement reflected the influence of the Drug Enforcement
Administration, which he said had long pressured the F.D.A. to help in
its fight against marijuana. A spokeswoman for the Drug Enforcement Administration
referred questions to Mr. Walters's office. The Food and Drug Administration's statement said state
initiatives that legalize marijuana use were "inconsistent with
efforts to ensure that medications undergo the rigorous scientific
scrutiny of the F.D.A. approval process." But scientists who study the medical use of marijuana said in
interviews that the federal government had actively discouraged
research. Lyle E. Craker, a professor in the division of plant and
soil sciences at the University of Massachusetts, said he submitted an
application to the D.E.A. in 2001 to grow a small patch of marijuana
to be used for research because government-approved marijuana, grown
in Mississippi, was of poor quality. In 2004, the drug enforcement agency turned Dr. Craker down.
He appealed and is awaiting a judge's ruling. "The reason there's
no good evidence is that they don't want an honest trial," Dr.
Craker said. Dr. Donald Abrams, a professor of clinical medicine at the University
of California, San Francisco, said he had studied
marijuana's medicinal effects for years but had been frustrated
because the National Institutes of Health, the leading government
medical research agency, had refused to finance such work. With financing from the State of California, Dr. Abrams
undertook what he said was a rigorous, placebo-controlled trial of
marijuana smoking
in H.I.V. patients who suffered from nerve pain. Smoking marijuana
proved effective in ameliorating pain, Dr. Abrams said, but he said he
was having trouble getting the study published. "One wonders how anyone" could fulfill the Food and
Drug Administration request for well-controlled trials to prove
marijuana's benefits, he said. Marinol, a synthetic version of a marijuana component, is approved to treat anorexia associated with AIDS and the nausea and vomiting associated with cancer drug therapyo:p> GW Pharmaceutical, a British company, has received F.D.A.
approval to test a sprayed extract of marijuana in humans. Called
Sativex, the drug is made from marijuana and is approved for sale in
Canada. Opponents of efforts to legalize marijuana for medicinal uses
suggest that marijuana is a so-called gateway drug that often leads
users to try more dangerous drugs and to addiction. But the Institute of Medicine report concluded there was no
evidence that marijuana acted as a gateway to harder drugs. And it
said there was no evidence that medical use of marijuana would
increase its use among the general population. Dr. Daniele Piomelli, a professor of pharmacology at the
University of California, Irvine, said he had "never met a
scientist who would say that marijuana is either dangerous or
useless." Studies clearly show that marijuana has some benefits for
some patients, Dr. Piomelli said.
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