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."
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.)