Participation and privacy
OMOP's agenda reflects strong industry interest in shaping and supporting Sentinel policies and operations. Unfortunately,
this coalition is the primary way for manufacturers to influence the project. There are no industry representatives on the
Sentinel planning board, and OMOP is not an official participant in the program, largely due to concerns among some stakeholders
that manufacturer involvement could rtaint the validity of results. Pharmaceutical companies may feel compelled to build independent
versions of Sentinel if excluded from the FDA project and denied access to Sentinel data. Woodcock noted that the mini-Sentinel
system can't yet support third-party postmarketing analysis, and that FDA will have to deal with industry access once the
"industrial strength Sentinel" emerges.
Ensuring the privacy and security of patient health records is also key to shaping the Sentinel program. One core advantage
of the distributed data model is that FDA avoids building its own mega-database and instead leaves individual patient health
information with the insurance company or healthcare 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, however, how
well FDA can assess safety signals with this arrangement. FDA staffers will be able to access de-identified data from Medicare
and perform their own analysis, but it still may be hard to confirm whether a safety issue is real based on such limited information.
Another tricky issue for industry and policymakers is the timing of public disclosure of safety information. "The biggest
risk to Sentinel is false positives," comments Marcus Wilson, president of HealthCore, the data analysis subsidiary of WellPoint.
Information that is released too early increases the possibility that a report may be wrong or incomplete and, thus, raises
unnecessary alarm. But delaying communication on an emerging safety issue may result in patient harm and expose program participants
to "failure to warn" liability charges. At the Sentinel workshop, attorney Kristen Rosati encouraged FDA to develop model
procedures for when, how, and to whom to report drug safety findings to set a policy that can be applied in court.
FDA also 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.
Sentinel's prime purpose is to serve FDA's regulatory mission, but it eventually may be part of a multipurpose network that
provides safety information to multiple public and private users, said McClellan. For example, the program can support the
International Serious Adverse Events Consortium's search for genetic links to drug-induced safety problems. In the longterm,
Sentinel may be part of a larger health information system that provides data for outcomes studies, comparative-effectiveness
research (CER), and health-system quality reporting. Manufacturers support building such a network, said Paul Stang of Johnson
& Johnson, but building one requires more investment.
Carolyn Clancy, director of the Agency for Healthcare Research and Quality, concluded the workshop by describing a range of
initiatives to improve patient registries and to build distributed data research networks that can answer queries related
to the effectiveness and safety of medical services and products. An overarching goal is to identify synergies between postmarketing
surveillance and CER and to provide incentives for healthcare providers to participate in eHealth activities.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, firstname.lastname@example.org