Pubdate: Fri, 21 Apr 2006
Source: Gainesville Sun, The (FL)
Copyright: 2006 The New York Times Company
Contact:  http://www.sunone.com/
Details: http://www.mapinc.org/media/163
Author: Gardiner Harris, New York Times
Note: The FDA Statement is at 
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html
Cited: The Institute of Medicine report 
http://www.nap.edu/readingroom/books/marimed/
Bookmark: http://www.mapinc.org/mmj.htm (Marijuana - Medicinal)
Bookmark: http://www.mapinc.org/walters.htm (Walters, John)
Bookmark: http://www.mapinc.org/people/Mark+Souder
Bookmark: http://www.mapinc.org/people/Lyle+Craker
Bookmark: http://www.mapinc.org/people/Donald+Abrams
Bookmark: http://www.mapinc.org/topics/Food+and+Drug+Administration

F.D.A. DISMISSES MEDICAL BENEFIT FROM MARIJUANA

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 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 therapy.

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.

"We all agree on that," he said. 
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MAP posted-by: Richard Lake