Wednesday, May 6, 2015

Memo to the FDA: Release Survey Data

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.


Chris Price said...

It would be nice if data obtained with public funds were to be available to those who have paid for it. Some places have laws that enforce this.

Brad Rodu said...

At the NATO meeting two weeks ago, Mr. Zeller stated that the FDA had spent $449 million on research; it is likely that most of this money was funneled through the NIH extramural grant program. He discussed the PATH study but did not provide information about its cost. It is listed at the FDA-NIH Research Portfolio ( ) but unlike the other projects on that page, there is no financial information. I found a 2012 presentation by Wilson Compton of NIDA ( ) that presents an estimate. On page 16 of the pdf he indicated that PATH was budgeted at $117.4 million “for base plus option years.”

Karyyl said...

What about FOIA?

Brad Rodu said...

A FOIA is a great way to obtain information that would not otherwise be released by the government. The FDA has committed to release the PATH study data, but probably long after it has published its interpretation in one or more studies, in a manner similar to how the CDC treats the National Youth Tobacco Survey. Before release, the PATH data must be anonymized to prevent identification of participants. But this is done routinely with other federal surveys, and a budget of $117 million should provide resources to get this done quickly.

Athanasius Kircher said...

Someone needs to get Judicial Watch to sue them for the data and the report.