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Friday, April 21, 2006
FDA rejects medicinal use of marijuana
Agency contradicts scientists, jumps into a political struggle
By GARDINER HARRIS
THE NEW YORK TIMES
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."
ON THE WEB
For more information about Washington's medical marijuana law, go to:
www.doh.wa.gov/
FDA rejects medicinal use of marijuana
Agency contradicts scientists, jumps into a political struggle
By GARDINER HARRIS
THE NEW YORK TIMES
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."
ON THE WEB
For more information about Washington's medical marijuana law, go to:
www.doh.wa.gov/
