The New York Times has produced yet more revalations about how data about Guidant's implantable cardiac defibrillators (ICDs) has been witheld. A reporter asked the US Food and Drug Administation (FDA) for results of the reports Guidant has been sending annually about device failures. According to the Times, "under little-known FDA regulations, the makers of defibrillators and pacemakers must provide detailed data each year to the agency, including the frequency of failure in individual models, the cause of such failures and the number of deaths and injuries."
But in response to the Times' inquiry, an "agency official," Joy B. Lazaroff, said "this information is a trade secret and exempt from release."
A Guidant spokesperson, Steven Tragash, "declined to respond to written questions on the frequency of the risk assessments of the Prizm 2 DR [a model of an ICD]...." Furthermore, Mr. Tragash would not let the CEO of Guidant, Ronald W. Dollens, submit to an interview on the topic.
I can't comment on the legal aspects of this case, but surely from a policy perspective, the FDA, which is charged with protecting US citizens' health and safety, should not be hiding data on potentially life-threatening failures of cardiac devices as "trade secrets."
The Times editorial staff apparently now also agrees that the Guidant issue is an important one. On Sunday, a Times editorial entitled "When a Heart Device Short-Circuits," based on the Guidant case, called for improved regulation of medical devices.
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