How the FDA Sat On Data About Failures of Guidant’s Implantable Cardiac Defibrillators

The story of failures of implanted cardiac devices made by Guidant just gets more complex. The New York Times reported this week that Guidant had sent detailed data about the performance of its implantable cardiac defibrillators (ICDs) to the US Food and Drug Administration (FDA) in February, 2005. This included data that suggested that about one of its Ventak Prizm 2 DR defibrillators was failing a month. The FDA did not make public this information suggesting a relatively high failure rate for the device, partly because the FDA treats such information as confidential. Dr. Daniel G Shultz, director of the FDA Center for Devices and Radiological Health, said that it would take too many resources to review “hundreds of filings the FDA receives each year and determine which data should be routinely released and what should be treated as confidential.” The news article also noted that “the FDA initially refused a Times request for several years of Guidant annual filings that was made under the Freedom of Information Act, contending that the filings contained trade secrets.”
We have posted frequently about the ongoing Guidant saga. A recent post is here, with links to earlier ones.
Before I had a chance to write some blustery prose about this latest part of the saga, the New York Times editorial page beat me to it.

The deplorable story of how a medical-device company sat information about a flawed heart defibrillator while a hapless recipient died has now engulfed the Food and Drug Administration as complicit in the silence.
What is disturbing is how long it took the company, the Guidant Corporation, and the regulators to get a meaningful warning to doctors and patients.
The agency’s excuse for not making the failure data public right away is too feeble to withstand scrutiny.

The bigger points are:
The FDA needs to rededicate itself to protecting the health and safety of the public as its first mission. Being nice to pharmaceutical and device manufacturers is a distant second.
Pharmaceutical and device manufacturers must remember that if they want physicians and patients to trust them enough to buy their products, often offered at very handsome prices, they must be absolutely honest and transparent in how they present data about their products’ performance to them. Insisting on the confidentiality of data about clinical results of using devices will not inspire such trust.