An update on the activities of the FDA Center for Tobacco
Products was provided two weeks ago by Director Mitch Zeller at a meeting of
the National Association of Tobacco Outlets (NATO). Zeller repeatedly referred to the Population
Assessment of Tobacco and Health (PATH) Study, “…a longitudinal cohort study on
tobacco use behavior, attitudes and beliefs, and tobacco-related health outcomes
among youth…and adults in the United States.” (description here).
Zeller said that agency staff presented information from the
study at a scientific meeting earlier this year, and that additional reports would
be forthcoming. In fact, the FDA and a
privileged group of investigators at Roswell Park Cancer Institute, the
National Institute of Drug Abuse and Westat, a private consulting firm, are producing information based
on a comprehensive dataset that is not available to anyone else.
During the NATO public Q & A session, I asked Zeller if
the FDA had set a date for public release of the PATH dataset. He answered in the negative.
Here we go again. For
years, I have documented that the CDC routinely withholds the underlying data
it uses to calculate the “Big Kill” estimates of smoking related deaths (here
and here) which are used to drive tobacco
regulations and federal policy. Additionally,
the CDC and American Cancer Society refuse to release data (here) on the minuscule risks of smokeless tobacco use -- data that could support
product applications for reduced-risk status (I have described what the
Society should do to remedy this here). These organizations have
treated smokeless tobacco users with contempt by refusing to release this
information.
This
institutional data embargo now affects e-cigarette users. Every year, the CDC parlays its exclusive
access to the National Youth Tobacco Survey to convince Americans that
e-cigarettes will enslave and kill their children (here and here). When the CDC releases the
data months or years later, a completely different picture emerges (here).
As for the PATH study, the FDA timeline
shows that it plans to “finalize restricted Use Data Set [public release] for
baseline data” in the Fall, with simultaneous release of a “complete first
manuscript of baseline results.” In
other words, the FDA will start spinning the results before it releases the
data for independent analysis. This is
unacceptable; if the dataset is good enough for the FDA to produce a
publication, then it is good enough for public perusal.
For 20 years, biased analyses of restricted federal datasets
have driven tobacco litigation, legislation and regulation. The FDA should make the PATH survey publicly
available at the earliest possible date.
