Last week , the New York Times reported yet another recall of cardiovascular devices made by Guidant, this time, pacemakers in its Insignia and Nexus lines. Although Guidant got its first reports that these models could fail in 2003, a US Food and Drug Administration (FDA) inspection noted that "the products continued to be distributed and users have not been informed of a potential no-output failure mode."
This is just the latest case of Guidant seemingly delaying making information about device failures available to doctors and the public. (See our most recent post on Guidant here, with links to earlier ones.) Senator Charles E. Grassley (R-Iowa) now is calling for his Senate Finance Committee to review Guidant's compliance with a corporate integrity agreement with the US Department of Health and Human Services (DHHS). This, in turn, was part of a settlement Guidant made after it had plead guilty to 10 charges that it failed to notify the FDA about malfunctioning aortic stents made by its Endovascular Technologies subsidiary.
A related Indianapolis Star story noted that the pacemaker recall is the fifth by Guidant since May, 2005. The Pioneer Press added noted that the latest recall is of 170,000 pacemakers, and 80% of Guidant's "heart products are [now] under recall or advisory."
On top of all that, the New York Times just reported how Guidant seems to have conflated research and marketing efforts, based on company documents and emails about a project to ostensibly evaulate a new electrical lead for cardiac resynchronization devices, essentially sophisticated pacemakers, priced at $29,000. Doctors received $1000 for implanting the leads in three patients and completing five surveys. However, the Times concluded that "the initiative also had another apparent goal - increasing sales of the company's most sophisticated and expensive heart devices." One email message said:
It generated 300+ implants. Let's say that just 25% were incremental ... that yields >$2 million in new sales with physicians who are not necessarily Guidant friendly. We paid each physician who completed all five surveys $1000 so our total cost was $80,000.As the Times said, "Guidant documents and recent interviews suggest that the line between research and product promotion may also be blurring where heart devices are concerned."
So, in summary:
- Guidant has repeatedly kept information from physicians and the public about failures of its devices, some of them potentially life-threatening. Guidant first plead guilty to such offenses in 2003.
- Guidant has also allegedly cloaked its marketing efforts for expensive pacemakers in the guise of a research project.