[Mb-civic] F.D.A. Dismisses Medical Benefit From Marijuana

[ean at sbcglobal.net]

F.D.A. Dismisses Medical Benefit From Marijuana 

By GARDINER HARRIS
Published: April 21, 2006
http://www.nytimes.com/2006/04/21/health/21marijuana.html?_r=1&ex
=1146283200&oref=slogin
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 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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