FDA REJECTS MEDICINAL USE OF MARIJUANA

Agency Contradicts Scientists, Jumps into a Political Struggle

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 that 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 that 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, including Washington, have legalized medicinal uses of
marijuana, but the Drug Enforcement Administration and the nation's
drug czar, 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.

A 1998 voter-approved initiative legalized medical marijuana in this
state. The measure allows residents with certain terminal or
debilitating diseases such as cancer and AIDS to grow, possess or use
marijuana for relief.

But marijuana still cannot be legally bought here, and there is no
identified legal way to distribute it. However, a 2003 ballot measure
made small marijuana arrests the lowest priority for Seattle police

Congressional opponents and supporters of medical marijuana have each
tried to enlist the FDA to support their views. 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."

"I know what it does for me medically," said JoAnna McKee, co-founder
of The Green Cross Patient Co-op, which connects people with
marijuana for medical use. McKee, who lives in Seattle, smokes
marijuana to control the pain caused by a spinal cord injury. "It
lowers the pain. It stops the muscle spasms. It stops the nausea."

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 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 in its 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 finance 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."