FDA Ends Secret Reporting on Medical Devices
From 1999 until last Friday, a lot of data was not public. FDA releases millions of records of incidents involving medical devices.
Alternative Summary Reporting. If that doesn’t sound like bureaucratic double-speak, I don’t know what does.
So MILLIONS of previously private records of “adverse effects” of medical devices have been made public. Millions. It was sold as just “more efficient reporting,” but there were aspects that look like a good-old-fashioned coverup.
The decision to revoke the ASR program apparently includes the revocation of an even more obscure program called “retrospective summary reporting,” which was so secret that a spokesperson for Johnson & Johnson once claimed the program did not exist — until presented with a J&J subsidiary’s own filings in the program.
Not all reports mean that the device was to blame, but this is the kind of program that bureaucrats love. They can help the friends (and maybe future employers) and the people really don’t need to do anything but trust the government. They would never lie about bad things happening, would they?
I know this is old news, from last Friday, but I missed it.