TURNING THE TABLES WITH MARY JANE

Some of this is about--marijuana. Just so you'll know, there's nothing
in here about what we were all doing back in the day (though of
course, we never inhaled). The reason to give marijuana some attention
here is a legal case that has wedged open an important chapter in the
relationship between law and science. It pits some health activists
against a law in the United States called the Data Quality Act (DQA).
The turnaround is that DQA has usually helped industry fight off
regulation. Not this time; here's the background.

Many basic scientists would be uneasy if their primary data--not
what's in their publications, but what's in the lab notebooks--would
be available for others to fiddle around with and then publish a
different conclusion. But in another scientific culture, that's
routine. In the U.S. Food and Drug Administration, where science has
regulatory outcomes, inspectors go regularly into labs to look at the
books.

Well, these cultures occasionally merge to generate political action.
Back in the '90s when the U.S. Environmental Protection Agency was
revising the National Ambient Air Quality Standards for ozone and
small particles, its staff used the Six Cities Study, a Harvard School
of Public Health analysis demonstrating a correlation between
particulate concentrations and mortality. Recognizing that Six Cities
could escalate the risk of particulate regulation, industry demanded
the primary data tapes so that they could reanalyze them. Harvard said
no, but soon Congress took over.

First, Senator Richard Shelby (R-AL) introduced an Amendment to the
1999 Omnibus Appropriation Bill charging the Office of Management and
Budget (OMB) to guarantee access, under the Freedom of Information
Act, to data produced with the use of federally funded research. After
two rounds of rule-making, OMB issued a final order putting the Shelby
Amendment in regulatory form. That opened the door to the DQA, an
amendment to the Paperwork Reduction Act of 1980. OMB, in response,
required each agency to establish guidelines ensuring the "quality,
objectivity, utility, and integrity" of information it disseminates.
DQA's legislative history is sparse, because like the Shelby
Amendment, it was tacked onto an appropriations bill in the dark. Its
real author was an industry lobbyist named Jim Tozzi, who had also
worked on the Shelby Amendment. Thus, the DQA is often called "Son of
Shelby."

It should not surprise us that the DQA has seen heavy use. The ink on
the OMB regulation had scarcely dried when the Center for Regulatory
Effectiveness, headed by none other than Jim Tozzi, urged its
constituents to use DQA to challenge the "junk science" offered to
support health and environmental regulation. Naturally, the Center for
Progressive Reform exhorted its troops to get active on the other
side. Who won? It wasn't even close. By 2004, the Washington Post had
counted 39 serious challenges under the DQA, of which 32 had been
filed by industry or industry organizations.

Now, back to marijuana. Americans for Safe Access (ASA), a group
advocating marijuana availability for severely ill patients needing
pain or nausea relief, petitioned the Department of Health and Human
Services (HHS) under the DQA in 2004. They alleged that HHS made false
statements in its publications and its Web site, in particular that
marijuana "has no currently accepted medical use in treatment in the
United States." ASA cited an Institute of Medicine study that
acknowledged benefits from the use of marijuana and cannabinoid
derivatives and referenced double-blind clinical trials demonstrating
relief from pain and vomiting. HHS delayed a response for months
beyond its own deadline, rejected the petition, and then rejected the
appeal.

ASA finally brought its case to federal court, asking it to substitute
for the agency's false statement one that says, "Adequate and
well-recognized studies show the efficacy of marijuana in the
treatment of nausea, loss of appetite, pain and spasticity." Will the
judge make HHS change, giving ASA the injunctive relief it seeks?
We'll have to wait to see whether this case turns the tables on DQA,
but it's already clear that HHS has violated its own DQA
guidelines--going, you might say, one toke over the line.

Donald Kennedy is the Editor-in-Chief of Science.