Call for Transparency and Physician Input at Guidant

We have posted frequently about the troubles afflicting Guidant Inc (scheduled to be acquired by Boston Scientific). These troubles revolved around Guidant's failure to reveal defects in its implantable cardiac devices. (See posts here, here, here, here, and here.)

The New York Times has just revealed the findings of an external review that Guidant, to its credit, commissioned. Its main findings were:

• "Decisions on how to assess product defects were made by Guidant engineers rather than medical experts."
• "As a result, Guidant officials could claim a device's performance fell within engineering limits without considering the medical consequences of product failures...."
• "'There was no medical input to speak of' in the review process...." "Even the top medical officer of Guidant's cardiac device unit, Dr. Joseph Smith, acknowledged in an interview with the panel that he had not been hired to be a 'patient safety officer' but rather to interact with other physicians on educational issues."

The panel's conclusions were striking, "in addition to recommending the creation of an outside panel to monitor device performance, the panel suggested that Guidant, among other things, employ a physician whose main duty would be patient safety. The group also concluded that both Guidant and other makers of heart devices needed to significantly increase the level of data they collected about possible device failures."
More transparency, and involving physicians, not just managers and engineers, in decisions affecting patients' well being sounds just about right. (We have been saying similar things on Health Care Renewal for quite a while.)