FDA SAYS NO STUDIES SUPPORT MARIJUANA FOR MEDICINAL USE

Pronouncement From Feds Contradicts Scientists' 1999 Review

WASHINGTON -- 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 the statement resulted from a
past combined review by federal drug enforcement, regulatory and
research agencies that concluded that "smoked marijuana has no
currently accepted or proven medical use in the United States and is
not an approved medical treatment." She said the FDA was issuing the
statement because of numerous inquiries from Capitol Hill but would
likely do nothing to enforce it.

"Any enforcement based on this finding would need to be by DEA, since
this falls outside of FDA's regulatory authority," she said.

Eleven states have legalized medicinal uses of marijuana, but the Drug
Enforcement Administration and the nation's drugczar, John Walters,
have opposed those efforts. A Supreme Court decision last year allowed
the federal government to arrest anyone using marijuana, even in
states that have legalized its use.

Congressional opponents and supporters of medical marijuana have each
tried to enlist the FDA to support their views. U.S. Rep. Mark Souder,
R-Ind., a fierce opponent of medical marijuana initiatives, proposed
legislation two years ago that would have required the FDA to issue an
opinion on the medicinal properties of the drug.

Souder believes that efforts to legalize medicinal uses of marijuana
are "a front" for efforts to legalize all uses of marijuana, said
Martin Green, a spokesman for Souder.

Tom Riley, a spokesman for Walters, hailed the FDA statement, saying
that it would put to rest "the bizarre public discussion" that has led
11 states to legalize the drug's use.

The FDA 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 evaluative 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-chair of the Institute of Medicine committee that
examined the research into marijuana's effects, said in an interview
that the FDA statement and the combined review by other agencies were
wrong.

The federal government "loves to ignore our report," said Benson, a
professor of internal medicine at the University of Nebraska Medical
Center. "They would rather it never happened."

Some scientists and legislators said that the agency's statement about
marijuana demonstrates that politics is trumping science there.

"Unfortunately, this is yet another example of the FDA making
pronouncements that seem to be driven more by ideology than by
science," said Dr. Jerry Avorn, a professor at Harvard Medical School.

Rep. Maurice Hinchey, D-N.Y., who has sponsored legislation seeking to
allow medicinal uses of marijuana, said that the statement reflected
the influence of the DEA, which he said had long pressured the FDA to
help fight against marijuana.

Dan Troy, the FDA's former general counsel, said that the FDA and DEA
often disagree about drug policies, but marijuana
"is a place where FDA and DEA can cooperate."

A spokeswoman for the DEA referred questions to Walters'
office.

The FDA statement said that state initiatives that legalize marijuana
use "are inconsistent with efforts to ensure that medications undergo
the rigorous scientific scrutiny of the FDA approval process."

But scientists studying marijuana said in interviews that the federal
government has actively discouraged research into marijuana's
benefits. Dr. Lyle Craker, a professor in the division of plant and
soil sciences at the University of Massachusetts, said that he
submitted an application in 2001 to the DEA to grow a small patch of
marijuana to be used for research because the government-approved
marijuana, grown in Mississippi, is of poor quality.

In 2004, the drug enforcement agency turned 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," Craker said.

Dr. Donald Abrams, a professor of clinical medicine at the University
of California San Francisco, said that he has studied marijuana's
medicinal effects for years but has been frustrated because the
National Institutes of Health has refused to fund such work.

With funding from the state of California, he undertook what he said
was a rigorous, placebo-controlled trial of marijuana smoking in HIV
patients who suffered from nerve pain. Smoking marijuana proved
effective in ameliorating patients' pain, but he is having trouble
getting the study published, he said.

"One wonders how anyone could" fulfill the FDA 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 therapy.

GW Pharmaceuticals, a British company, has received FDA approval to
test in humans a sprayed extract of marijuana. Called Sativex, the
drug is made directly from marijuana plants and is presently sold in
Canada. Opponents of efforts to legalize marijuana for medicinal uses
suggest that marijuana is a "gateway" drug that often leads users to
try more dangerous drugs and become addicted.

But the Institute of Medicine report concluded that there is no
evidence that marijuana acts as a "gateway" to harder drugs. And it
said that 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 that he had "never met a scientist would who
will say that marijuana is either dangerous or useless."

He said that studies clearly show that marijuana has some benefits for
some patients.

"We all agree on that," he said.