FDA Opposition to Medical Marijuana Fuels Controversy

April 21, 2006

HealthDay News, Forbes

The announcement by U.S. Food and Drug Administration officials late Thursday that the agency does not support the medicinal use of marijuana quickly re-ignited controversy from both sides of the debate.

In a statement, the FDA said it, along with other agencies in the Health and Human Services Department, has concluded that "no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use."

The FDA's statement contradicts a 1999 review by experts at the Institute of Medicine (IOM), a division of the U.S. National Academy of Sciences, which found marijuana to be "moderately well-suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting."

The federal government "loves to ignore our report," Dr. John Benson, a professor of internal medicine at the University of Nebraska Medical Center and co-chairman of the Institute of Medicine committee that examined the research into marijuana's effects, told The New York Times. "They would rather it never happened."

Dr. William M. Lamers, a consultant to the Hospice Foundation of America, which represents palliative-care centers across the country, told HealthDay: "It's too bad that instead of a statement like that, they [the FDA] don't put money into doing some really valid research. There is none being done now in the United States."

But others came out in support of the FDA's stance.

A spokesman for John P. Walters, director of the U.S. government's national drug control policy, said that the FDA's announcement should help put an end to what he called "the bizarre public discussion" that has led some states to legalize marijuana for medicinal use.

And Susan Bro, an FDA spokewoman, told the Times that her agency's decision arose from a prior review by federal drug enforcement, regulatory and research agencies. That review found that "smoked marijuana has no currently accepted or proven medical use in the United States and is not an approved medical treatment," she said.

Bro added that the FDA has no plans to enforce any laws governing medicinal marijuana use, and would leave that up to the U.S. Drug Enforcement Agency (DEA).

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

Currently, 10 states have passed legislation allowing the medical use of marijuana: Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Vermont and Washington. Arizona also enacted similar legislation, but with no formal program to administer marijuana by prescription.

Reacting to these laws, the FDA's statement said, "These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective."

As it stands, the DEA now has the right to enforce federal laws opposing the medical use of marijuana -- even in states that have passed legislation allowing its use. DEA raids have ended in the arrests of individuals in various states who claimed they were using marijuana to treat or ease illness.

Both the DEA and the FDA appear to have the U.S. Supreme Court on their side. In a 6-3 decision in June 2005, the court ruled that DEA agents were within their rights in 2001 to arrest two California residents -- one with brain cancer and the other with severe back pain -- who were using marijuana at the time to help ease their symptoms.

That decision means federal laws banning the use of medicinal marijuana now supersede any state legislation allowing the plant or its derivatives to be used for pain relief when recommended by a physician.

A spokesman for the Oregon marijuana-by-prescription program said he had no comment on the FDA statement. "Our job is only to administer a program approved by the voters," Jim Sellers said.

Lamers, of the Hospice Foundation of America, said his experience in palliative care has suggested that many people can benefit from the analgesia marijuana offers, "including relief from the nausea and vomiting that accompanies chemotherapy, and pain. It's a magnificent pain reliever, but with the caveat that in order to get the pain-relieving effect you have to be stoned."

Marijuana has also been effective in stimulating the appetite of people with AIDS and other conditions that are accompanied with a loss of appetite, Lamers said.

He framed the battle over medical marijuana as a bureaucratic turf war. "It's a matter of states rights versus federal rights," he said. "This involves not only marijuana, but is a carryover prohibition of the use of any of the opioids." Opioids include "harder" drugs such as morphine and heroin.

In the past, both the American Medical Association (AMA) and the National Multiple Sclerosis Society have said there is not enough evidence to support the use of medical marijuana. The AMA has said that research is needed to determine if marijuana is useful in treating pain and other medical conditions.



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