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Joint suits aim to weed out agencies' red tape

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Frustrated with the slow pace of research into medicinal marijuana, researchers have launched a pair of lawsuits accusing US government agencies of obstructing attempts to obtain supplies of the plant.

In order to study marijuana for its ability to ease pain, nausea or symptoms of AIDS, US researchers procure the drug from a small farm at the University of Mississippi, under contract from the National Institute on Drug Abuse (NIDA). But some complain that the red tape and long delays involved in getting the plant through NIDA, the Drug Enforcement Administration (DEA) and other agencies are unacceptable.

The lawsuits, filed on 22 July, were coordinated by the Florida-based campaign group Multidisciplinary Association for Psychedelic Studies (MAPS).

In one lawsuit, MAPS is demanding a decision on an application filed in 2003 to buy 10 grams of NIDA marijuana — a tiny amount worth just $70, the group says. The researchers plan to use the plant in testing a vaporizer, an alternative method of delivery to smoking. The test would look at the chemical constituents of the vapour and would not involve human subjects.

The second lawsuit contends that the DEA has stalled an application to set up a separate farm to grow marijuana for research, filed in June 2001 by botanist Lyle Craker of the University of Massachusetts at Amherst. If successful, this would be the first official alternative US marijuana source for medical researchers.

MAPS president Rick Doblin argues that the NIDA supply of marijuana is of low quality and potency, and that researchers will be unable to get clinical approval for drugs derived from it unless they can grow a pharmaceutical-grade crop themselves. He would like to see a situation like that in Britain, where Salisbury-based GW Pharmaceuticals, under licence from the Home Office, has established its own greenhouse facility to grow marijuana for clinical trials.

The US Department of Health and Human Services, NIDA and the DEA would not comment on the lawsuits. But those behind the legal action claim that the agencies are sitting on the applications because they go against the federal government's hard line on drugs. “It's politically unacceptable to say yes,” says Craker (see Nature 430, 394–395; 2004).

Other researchers in the field agree that the bureaucratic application process for marijuana studies has contributed to sluggishness in the field. “The pace has been slower than one would like,” says mental-health researcher Stanley Watson of the University of Michigan, Ann Arbor, who co-authored a 1999 Institute of Medicine report urging clinical trials into medicinal marijuana.

But that does not mean that NIDA is doing anything illegal, Watson says. The agency's remit is to study research linked to the abuse of drugs, he points out, not their medicinal use. “It's going to be a tough one for MAPS to win,” says Watson. Others add that there could be scientific problems with the MAPS applications that are holding things up.

Watson suggests that researchers might best forge ahead by improving the design of their trials, or perhaps by negotiating marijuana supplies from other countries.

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Multidisciplinary Association for Psychedelic Studies

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Pearson, H. Joint suits aim to weed out agencies' red tape. Nature 430, 492 (2004). https://doi.org/10.1038/430492a

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