Like the aftershocks from an earthquake, the political tremors after Vioxx don’t seem to subside. Yes, Merck’s strategy of swatting the pesky plaintiff lawyer-flies one at a time seems to be paying off. And yes, the FDA’s attempt to bolster its own drug safety efforts can now be pondered by a predictably divided and intemperate Congress. But the issue is squarely on the public agenda and is likely to remain there this year.

At times like these, people like Sanket Agrawal have a refreshingly contemplative and measured outlook. Agrawal is the chief strategy officer of Relsys International, a firm specializing in drug safety. He spoke at the recent etrials user meeting, about which this is (we promise) our final report. “Safety is very much at the forefront today,” Agrawal said. “Safety is in a paradigm shift now.”

The comments from Relsys were made well before the recent FDA announcement about drug safety. But they resonate all the same.

Referring to Pfizer’s decision to cancel torcetrapib, Agrawal said that the $800 million cost of the massive clinical trial was, of course, not chicken feed. “The next day, their market cap was sliced by $22 billion,” he said.

Echoing many in the industry, Agrawal laments the public’s desire to have utterly risk-free drugs. The public eye is less often turned to the benefits of drugs, he said. “A challenging task is to model and quantify benefits vs. risk,” he said.

Recruiting A CSO?

Noting that some Relsys customers are thinking of adding a “chief safety officer” at the corporate board level, Agrawal said that the sheer burden of managing aggregated and individual safety reports has meant that the larger goals have gotten lost: “Operations eat vision for lunch everyday. That is what is happening in the pharmaceutical industry right now. We are simply drowning in operations.” He estimates that for every report offered to a regulatory body, half a dozen additional reports may be requested. “The workloads have quadrupled,” he said.

Noting that most studies estimate that physicians only report five percent of the adverse reactions caused by drugs, Agrawal fretted about a hypothetical doubling of the reporting rate. It would not be pretty, he said.

Flashing a few Powerpoint slides, Agrawal noted that the standard approach to drug safety, throughout the industry, is reactive. “Most of the industry, most of the technology, is focused on retrospective knowledge. The real value here is when we start to get a more predictive model.”

‘The Right Integration’

For that, clearly, transactional, real time systems will need to lighten the burden of FDA reporting requirements, and allow medical personnel to focus on some presumably smaller percentage of cases that require expert analysis.  “With the right integration,” he said, “you can achieve nearly complete automation.”

For Agrawal, the promise of technology is a less strained shouldering of the responsibilities to regulators and the public. Technology should be able to help. “Productivity gains are crucial for a different reason,” he says. “Pharma will be able to make more active postmarketing commitments. Without efficiency, the industry does not have the bandwidth.”