Some people are happy with incremental progress. A long career in drug safety has left Michael Ibara searching for a bigger leap forward. He's the architect of a potential alternative to the present drug safety morass of paper, faxes, and inefficiency.

As head of pharmacovigilance information management at Pfizer, Ibara organized the Aster project, an exploration of new ways to involve more physicians in drug safety.

Aster relies on a tool that physicians already use: the electronic health record (EHR). Yesterday's ClinPage story explored the context for why Ibara came up with Aster. The project managed real postmarketing data in Boston and reported dramatic increases in physicians filing high-quality reports. Thanks to the doctors' usage of their own familiar EHR, they could fill out the electronic forms in a fraction of the time they had previously wrestled with submitting paper alternatives.

Fresh Start

Ibara is worried that there are just too many spontaneous reports flowing from industry toward regulators. Processing or analyzing those reports in a manual manner has been streamlined, up to a point. But those efficiencies are unlikely to keep up with the pace of digital drug safety reporting. The industry's budgets and staffing levels are just not rising in step with the surging data. So something will have to give. And Ibara is trying to figure out what might work.

"You can see a long history of attempted improvements and point improvements in the safety process, but that's not gonna cut it anymore," Ibara says. "We're going to have to figure out a system design."

Is paper, in some cosmic sense, the heart of the problem? Can anyone in the industry or the U.S. government stand proudly behind a process that relies so heavily on ... facsimiles? It's not that simple, Ibara says.

Beyond The Balkans

While he concedes some personal frustration with paper, Ibara doesn't predict it will disappear. He prefers a new, technologically-assisted way to analyze spontaneous reports automatically and funnel the most important ones to humans for additional analysis: "The answer there, though, is not to get rid of paper as an adjunct to what we do, but to get rid of paper as part of the critical path of what we do."

The Europeans, he notes, are discovering that just making the reports electronic doesn't solve everything. "Each company has to report to each regulator in every country," Ibara says. "And you will find that in terms of the estimates of how much work that's saved for us, it actually caused more work than it saved. The model in Aster is attempting to solve that problem along with the problem of getting a high-quality report out of the EHR."

His ideas may be controversial in some circles in Washington, but any modern, ordinary person should be able to understand that the Dickensian processing of hundreds of thousands of pieces of paper is probably not the best way to determine if drugs stay on the market.

One element of Ibara's vision has been little discussed at industry conferences. He sees a role for an impartial, trusted clearinghouse that might have both governmental and private members. It wouldn't replace the regulators, obviously. Rather it would manage some of the oceanic waves of data so that physicians, government and industry could have confidence in the data being forwarded to decisionmakers. This intermediary, in Ibara's view, could be a company or nonprofit with a budget and staff.

New Role

Part of the need for such a body is technical, Ibara believes. Data standards bridging the pharmaceutical R&D complex and the general health care landscape are still not fully synchronized. "We are several years, if not more, away from standards allowing a complete free exchange between different types of entities," he notes.

The clearinghouse is still highly theoretical, but it could pipe data to the FDA, to European authorities or to academia. And the clearinghouse might also pump data back to industry for additional clarification.

In a less-polarized, less litigious society, nothing Ibara is discussing would be controversial. But the details of how such a clearinghouse would be established, funded and run are a bit murky. Ibara makes it clear that some of his thinking is his own, not Pfizer's.


Ibara thinks the U.S., in the end, could have a very satisfactory system if the stakeholders can agree on what constitutes a high-quality drug safety report in the 21st century. Once that's settled, the technology is almost an afterthought.

Ibara doesn't have entrenched opinions on who should control or establish a drug safety clearinghouse, except to say that his hunch is that both government and industry should have some voting privileges, and that neither should have sole control.

Beyond that, his intuition tells him such an organization might simultaneously alleviate the information-management burden on regulators and increase waning public confidence in pharmaceutical research as an ethical endeavor. Says Ibara: "It's my conviction that it will need to be, in some sense, an intermediary between the sources of the information and the recipients of the information."

Editor's note: This is the second part of a two-part series. The first article can be found here, with a podcast here. The podcast is free but requires registration on the website. The podcast page includes a 15-page transcript of the interview with Ibara that explores data standards, European experiences and the proper role for contract research organizations. Ibara is speaking at the Post-Approval Summit. That conference is organized by Outcome and features unusually prominent speakers from the sponsor community and the regulatory world.