FDA: Marijuana not a medicine

April 26, 2006

Bob Roehr, Bay Area Reporter

The Food and Drug Administration rejected any claims that smoked marijuana is a medicine, saying, "No animal or human data supported the safety or efficacy of marijuana for general medical use." The April 20 statement came in response to inquires from Capitol Hill, most notably right-winger Representative Mark Souder (R-Indiana).

The FDA charged that state measures that allow for the use of marijuana for medical purposes "are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective."

However, the statement consistently referred to "smoked marijuana," perhaps leaving wiggle room for consideration of other forms of administration of the drug.

It cited several government evaluations of marijuana but it ignored a 1999 report by the independent and prestigious Institute of Medicine. That report noted promising anecdotal accounts of benefit and urged study of the product for a number of conditions including chemotherapy-induced nausea and AIDS-related wasting. Ironically, that report was commissioned by the White House drug czar, which paid $896,000 for the study.

Marijuana Policy Project spokesman Bruce Mirken called the FDA statement "an odd piece of work. They make no claim that they have any new data or new analysis of old data, so why are they doing it now?"

"It weirdly mischaracterizes what state medical marijuana laws are about. And the whole notion that this is some kind of end run around the FDA is just silly," Mirken said.

Eleven states have laws allowing for the medical use of marijuana that were passed either by voter initiative or the legislative process.

California has even gone so far as to establish the Center for Medicinal Cannabis Research within the state university system as a means by which to bypass reluctance on the part of federal agencies to study the possible beneficial aspects of marijuana.

Americans for Safe Access previously filed an administrative petition with the Department of Health and Human Services under the Data Quality Act, challenging the finding that marijuana has no medicinal value. By law, HHS is supposed to respond within 60 days, but it has taken six 60-day extensions, delaying its response by more than a year.

"If the agency believed that marijuana did not have medical value, they could have rejected the petition and provided their rationale," Bruce Levinson told the trade publication FDA Week . Levinson is with the Center for Regulatory Effectiveness, a nonprofit that pushed for the DQA but is not involved with the marijuana petition.

"My only conclusion is that the sixth extension reflects FDA unease with both their own formal position on the medical value of marijuana and with their legal position should the issue go to court," he said.

The pending confirmation hearing and vote on the nomination of Andrew von Eschenbach as FDA commissioner is a natural place to raise these issues, medical marijuana advocates said. Given that California voters overwhelmingly support the medical use of marijuana and even fund research in that area, U.S. Senators Dianne Feinstein and Barbara Boxer would seem to be logical persons to raise the issue during those hearings. Boxer already has suggested that she might place a hold on the nomination pending long-delayed approval of "Plan B," the so-called morning after birth control pill.

But Mirken is not optimistic. "I don't know of any issue that has such a disconnect between public opinion and the behavior of politicians. What else that has 78 percent support that politicians are so afraid of? Barbara Boxer has been entirely missing in action, and Feinstein actually opposed Proposition 215."

"We won long ago in the court of public opinion; don't we elect these people to represent us? A lot of politicians are laboring under the delusion that it is harmful to their career to be 'soft on drugs,' they just need to hear from people. Call, write, send e-mails," Mirken urged.

"The war in Iraq is bad enough. But the war on drugs has lasted longer and cost more money and more American lives," wrote libertarian David Boaz of the Cato Institute, online in the British newspaper the Guardian. "And neither Democrats nor Republicans are talking about withdrawal."




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