AdverseEvents.com Seeks to Keep Track of Drug Side Effects the Way the FDA Never Could
Some powerful people in the pharmaceutical industry would like to see Brian Overstreet and his startup fall flat. Big pharma companies, on a few occasions, have told him to stop his spiel immediately, because they were afraid they could be put in a legally and ethically dubious position by hearing one more word.
When I told a Bay Area venture capitalist about Overstreet’s startup concept last week, it triggered a gut reaction. “I’d like to put that one out of business!” the VC said (I think half-jokingly. I think).
All the nervousness is coming from a new company called AdverseEvents.com, a Healdsburg, CA-based startup that seeks to bring order to the notoriously sloppy world of reporting on adverse events, the bad reactions people have to prescription drugs. The company, which emerged from stealth mode yesterday at the Health 2.0 conference in San Francisco, has devised a 17-step “data refinement process” to help doctors and health officials gather meaningful insights from the FDA’s adverse event records database known as Medwatch.
The current system—in which doctors voluntarily fax or e-mail forms about bad reactions they suspect are drug-related—has numerous well-documented flaws. Only about 500,000 reports are sent to the FDA each year, about one-tenth of the estimated number of actual bad reactions. And once reports get entered, they are littered with misspellings, misclassifications, incomplete entries, and incompatible file formats that make it extremely difficult to search the database. Those barriers have made it tough for the FDA, or anyone else, to spot the early warning signs of a dangerous drug until millions of people have been exposed, creating front-page scandals and highly litigious cases like the ones with the pain reliever rofecoxib (Vioxx) and the diabetes drug rosiglitazone (Avandia).
If AdverseEvents.com can iron out the problems in the Medwatch database, and become an online repository for simpler side effect reporting, it’s conceivable this little startup could someday become an essential online resource for tracking side effects of $1 trillion worth of prescription meds sold around the world. It’s the kind of data source that could make or break multi-billion dollar products, and in some cases, entire companies.
“The FDA is making labeling decisions, product withdrawal decisions, post-market safety decisions based on raw data and it’s very clear there’s no way they can accurately do that,” Overstreet says. “It was a very scary moment when we realized that, but from an entrepreneurial standpoint, it’s a great opportunity.”
AdverseEvents.com, like a lot of health startups, got its founding inspiration from a personal experience. Overstreet, previously the co-founder and CEO of Sagient Research, became interested in the issue in January 2010 when a partner’s wife got sick from a bad drug reaction and ended up hospitalized. He and his partner did some basic Internet searches to find out data on rates and severity of side effects linked to the drug in question, and came up empty-handed. The only useful information came from the drug’s FDA-approved prescribing information, which is based on results from small, controlled clinical trials—not from real-world experience with the tens of thousands or even millions of people who may have been prescribed the drug.
The partner’s wife ended up … Next Page »