PARTICIPATION AND PRIVACY
OMOP's agenda reflects strong industry interest in shaping and supporting Sentinel policies and operations. Unfortunately,
this coalition is the main way for manufacturers to influence the project at this time because there are no industry representatives
on the Sentinel planning board and OMOP is not an official participant in the program, largely because some stakeholders believe
that manufacturer involvement could taint the validity of results. A main concern of the industry is that companies will be
denied access to Sentinel data for their own analysis or for postmarketing studies. Woodcock noted that the mini-Sentinel
system cannot yet support third-party postmarketing analyses, and that the FDA will have to deal with industry access after
the full "industrial-strength" Sentinel emerges.
Ensuring the privacy and security of patient health records is another key issue shaping the Sentinel program. The main advantage
of the distributed data model is that the FDA avoids building its own mega-database and instead leaves individual patient
health information with the insurance company or health system that holds the records. That data source evaluates the information,
transmits summaries to Sentinel, and confirms a specific diagnosis or report if needed. It remains to be seen how well the
FDA can assess safety signals through this arrangement; even direct access to de-identified data may not be sufficient to
confirm that a safety issue is real.
Another tricky issue for industry and policy makers is the timing of public disclosure of safety information. Releasing information
too early increases the possibility that a report may be wrong or incomplete and thus raise unnecessary alarm. But delaying
communication on an emerging safety problem may result in patient harm and expose program participants to "failure to warn"
liability charges. Moreover, the FDA has to determine how it will use Sentinel findings in regulatory decisions. Confirmation
of safety signals could result in changes in a product's labeling, agency alerts to healthcare professionals, and public warnings
about appropriate drug use. Despite concerns about the completeness, objectivity, and timing of drug safety reports, "what
we're going to get is going to be better that what we have right now," Woodcock predicted.
Although Sentinel's prime purpose is to serve the FDA's regulatory mission, the long-term vision is that the program will
become part of a larger health information system that also provides data for outcomes studies, comparative effectiveness
research (CER), and health system quality reporting. Manufacturers support the goal of building such a multipurpose network,
said Paul Stang of Johnson & Johnson at the workshop, but this requires more investment in research methods, in standards
for data sources and evidence, and in governance of emerging models.
Carolyn Clancy, director of the Agency for Healthcare Research and Quality (AHRQ), concluded the program by describing AHRQ
initiatives to build distributed data research networks and to improve patient registries that can answer queries related
to the effectiveness and safety of medical services and products. An over-arching goal is to identify synergies between postmarketing
surveillance and CER and to provide incentives for healthcare providers to participate in e-health activities.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org