Four times a year, the FDA releases data about all of the adverse drug events that have been reported to the agency over a three-month time period. Drug companies are required to relay reports they receive of unwanted side effects experienced with use of their products, and patients and doctors can submit reports to the FDA, too.
The problem is that when the FDA publishes the data, it publishes them in bulk files that are reportedly littered with duplicate records and misspelled drug names. When delivered that way, millions of data points representing valuable information about the safety of drugs on the market are nearly useless to physicians, health plans or patients who could benefit from them.
Enter AdverseEvents Inc., a healthcare informatics company giving new life to that data by aggregating it, cleaning it up, organizing it and providing analysis of it as a service to health plans and health systems.
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“For example, a client could quickly review the post-approval safety profiles of interferons versus Copaxone for the treatment of multiple sclerosis,” explained CEO Brian Overstreet. “Although on average Copaxone is costlier to the plan, and can be used interchangeably in a first-line setting, they quickly would be able to identify a clear safety advantage that Copaxone had over the interferons. When factoring in the downstream costs of side effects that occur (with interferons), the total costs were very similar.”
Overstreet and California-based AdverseEvents just closed in on a $2 million Series A that they will use to expand the sales and analysis teams and expand marketing efforts. Evaluate Ltd., a life science marketing intelligence firm, and angel investors also participated, AdverseEvents said.
Last month, the FDA pledged to make access to public data easier by opening its API and streamlining the download process.
“From a macro standpoint, we expect to benefit enormously from the OpenFDA initiative itself and more people working with the data,” Overstreet said. But it won’t eliminate the need for the analyses that AdverseEvents provides.
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“OpenFDA also does not address the data quality,” he said. “Our RxFilter process of cleaning it up will still be a differentiating factor off of which everything else we do is built.”
