Big Pharma and medical device makers have opened their wallets for a 2017 lobbying spree, throwing tens of millions of dollars around the nation’s capital, including to campaign with lawmakers and regulators to defend their soaring prices and to speed the path for their products to get to markets. But credit’s due to officials and organizations like Stat, the online health information site, for building a greater urgency behind a different narrative: It may be as crucial to monitor and regulate drugs and medical devices after they’re publicly available as pre-approval.
A two-part Stat report, aptly titled “Failure to warn,” dismantles existing oversight of prescription medications, especially regulators deeply flawed, big-data driven initiative dubbed Sentinel. The eight-year-old, $207 million program is supposed to mine insurance records to surface side-effects of drugs recently approved by the federal Food and Drug Administration.
But by examining 500,000 reports of side-effects from drugs targeted at the 1.5 million Americans with debilitating rheumatoid arthritis, Stat shows Sentinel’s shortcomings with Roche’s billion-dollar RA product Actemra. The FDA has received 1, 128 reports, complaining about patients who have died while taking it. But the agency, Stat says, “doesn’t have sophisticated tools to determine whether the drug was a culprit or a bystander in those deaths.”