View Full Version : Need more proof that the FDA works for the pharmaceutical companies?

04-21-2006, 01:35 PM
Health agency bolsters DEA's position, leaps into another political hot-button issue
Gardiner Harris, New York Times

Friday, April 21, 2006

Washington -- The Food and Drug Administration declared Thursday that "no sound scientific studies" support the medical use of smoked marijuana. The statement, which contradicts a 1999 review by top government scientists, inserts the health agency into yet another fierce political fight.

Susan Bro, an agency spokeswoman, said the statement resulted from a 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 probably 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 California -- 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.

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."

Dr. John Benson, co-chair 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 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."

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. Donald Abrams, a professor of clinical medicine at UCSF, said that he has studied marijuana's medicinal effects for years but has been frustrated because the National Institutes of Health has refused to fund 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.

04-21-2006, 01:38 PM

I didn't get past FD...... what's it about?

04-21-2006, 03:05 PM

I didn't get past FD...... what's it about?

ROFL Try again when you come down.