Kaiser Health News reports the FDA is hiding millions of adverse events from medical professionals and the public. Why would this be the case? The FDA was set up long ago to protect the public. According to the report, at least 1.1 million adverse event reports have been moved into the FDA’s “alternative summary reporting” system—inaccessible to the public and according to some reports completely hidden to most clinical research stakeholders. Apparently, this summary reporting system was designed for well-known and well-documented issues and purportedly includes 100 medical devices according to the Kaiser Health News report. The FDA declined to provide a full list of the approximately 100 devices granted reporting exemptions. Other key data points:
- 480,000 + injuries or malfunctions were reported in 2017 through the public but inaccessible system
- 2+ million events have been reported since 2014
A confluence of movements has converged to drive a push for greater transparency: and the FDA is feeling the pressure. Kaiser Health News reports that the transparency movement materializes with many Freedom of Information Act requests to obtain incident information—however waits for these requests can take years. FDA spokeswoman Alison Hunt believes the FDA program supports a more efficient and effective adverse event review process. In fact the program was originally intended to streamline the data review process; device manufacturers would send quarterly or bi-annual reports to the agency reporting on all related issues with a goal of ensuring reviewers could quickly identify trending or spiking issues.
This isn’t good enough. This is a public data base; possessed by a public agency; funded with public tax dollars! With the advent of all sorts of technologies including big data and machine learning this information needs to be liberated and moved into a system that is searchable. Why? First and foremost our health care professionals (provider, payer, community provider) need to access this information. They seek to understand the true risk of new investigational and approved treatments; the safety of drugs and devices are of paramount concern. With a move to transparency, including TrialSite News, we believe the public should have access to this information as well. A true, value-based health care system requires educated and informed consumers. Does the original impetus for the system still exist today? Do they want to protect but not empower our citizenry? Do they know what is better for our health than our doctors, nurses and for that matter, ourselves?
Former FDA manager, Madris Tomes, notes “the FDA is basically giving away its authority over device manufacturers.” Ms. Tomes runs Device Events—making device data user-friendly. She notes if the FDA has given up such an authority then “they’ve handed over their ability to oversee the safety and effectiveness of these devices.” Consequently physicians may not have holistic and comprehensive information about the risks tied to commonly used devices such as staplers according to the report. The report included stapler data.
- In the first 28 months of reporting through the system, Staple makers filed more than 5,100 malfunction reports or injuries related to the devices
- A review of public reports revealed 112 stapler-related deaths between 1994 and 2001.
In the Kaiser report Dr. S Lori Brown called these findings “ a reason for concern.” Perhaps medical professionals, clinical research stakeholders and consumers interested in their own health can show some unity and call for accessibility immediately.