Privacy and Participation

FDA's decision to launch Sentinel based on a distributed data model reflects earlier research by academic experts and by the Observational Medical Outcomes Partnership (OMOP) suggesting that this approach can best ensure the privacy and security of patient health records. Instead of FDA building its own mega-database, this strategy leaves individual patient information with the healthcare system that holds the records; that organization then evaluates the information, transmits summaries to Sentinel and confirms a specific diagnosis or report if needed. But even with the ability to do their own analysis on the de-identified data from Medicare, FDA experts still may find it hard to confirm that a safety issue is real.

Another tricky topic for sponsors and policymakers is the timing of public disclosure of safety information. A "too early" release increases the possibility that a report may be wrong or incomplete and thus raises unnecessary alarm. But delaying communication on an emerging safety issue could result in patient harm, and expose program participants to "failure to warn" liability charges. Legal experts want FDA to develop model procedures for when, how, and to whom drug safety findings will be reported in order to set a policy that can be applied in court.

Pharma companies want to be at the table when such important issues are discussed and decided, but fear they will be excluded from the process. There are no industry representatives on the Sentinel planning board, and OMOP—an industry-funded collaboration involving FDA, the Foundation for the National Institutes of Health and the Pharmaceutical Research and Manufacturers of America (PhRMA)—is not an official participant in the program. At the Sentinel workshop, Patrick Ryan, manager of drug development sciences at GlaxoSmithKline, noted the strong support of OMOP members for Sentinel, and said that the group is providing public access to all of its research findings, such as assessment of the diversity in analysis methods and of relationships between drug exposure and outcomes.

Pharma companies hope to access Sentinel data for their own internal analyses and for postmarketing studies, but anticipate having to build their own versions of Sentinel if forced to generate their own safety 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 full "industrial strength Sentinel" emerges.

The Broader system

While Sentinel's prime purpose is to serve FDA's regulatory mission, the long term vision is that it will be 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 such a multi-purpose network, but recognize that it will require more investment in research methods, governance, and standards for data sources and evidence.

Carolyn Clancy, director of the Agency for Healthcare Research and Quality, concluded the workshop by describing AHRQ 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. These activities reflect the overarching goal of identifying synergies between post-market surveillance and CER, while also providing incentives for health care providers to participate in e-health activities.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at jwechsler@advanstar.com