Steinbrook summarized the events in the case, including how in 2002 Guidant discovered a fault in its implantable cardiac defibrillators (ICDs) that could cause them to short-circuit and fail; how Guidant re-designed the devices in 2003, but continued to ship devices prone to the fault; and only notified physicians and the public of the problem in 2005. (We have posted frequently on the Guidant case, most recently here.)
The problems with Guidant's ICDs first became evident to physicians after a young man with an ICD implanted for hypertrophic cardiomyopathy (pathologic excessive growth of the heart muscle) died in 2005 of a rapid heart rhythm that his ICD failed to stop. Steinbrook reported how his physicians at the Minneapolis Heart Institute investigated, searching the Manufacturer and User Facility Device Experience (MAUDE) data-based held by the US Food and Drug Administration (FDA). They found other reports of short-circuit induced failures of Guidant ICDs. Steinbrook quoted Dr. Barry Maron, director of the Hypertrophic Cardiomyopathy Center:
"We became very concerned. We were keeping a secret not just from our patients and their physicians, but also from all the patients with the device and their physicians. On May 12, four Guidant officials came to my office and gave a very educational presentation. I asked, 'What are we going to do about this? We are in an untenable situation ethically and morally with our patients. How are we going to get the word out?' They said, 'Well, we are not. We don't think we need to. And we don't think it's advisable.' The officials expressed doubt that the patients would be able to understand the medical issues involved in determining whether or not to replace the devices. I said, 'I think this is the biggest mistake you will ever make.' They said they didn't agree."This appears to be a chillingly direct example of external threats to physicians' core values arising when the leaders of a large health care organization put the organization's short-term financial interests ahead of their ethical obligation to provide the information needed by doctors and patients to make good clinical decisions.
Steinbrook concluded, "For more than three years, Guidant kept quiet about the serious malfunctions of some of its ICDs and continued to sell defective devices after it made manufacturing changes to fix the defects. The company will have to regain the trust of patients and physicians."
The New England Journal and Robert Steinbrook deserve commendation for treating this story as one of broad significance. This article stands in sharp contrast to the kid-glove treatment given the Guidant's Chief Executive Officer Robert W. Dollens during his interview by a senior editor of Health Affairs (see our post here). The interviewer never acknowledged either that Guidant had manufactured ICDs that were prone to fail, that they had knowingly shipped such ICDs from stock after beginning re-designed models that corrected the fault, or that Guidant had concealed these facts from physicians and the public for three years. The Health Affairs interview seemed to be an example of the "anechoic effect," how stories about threats to physicians' core values arising from concentration and abuse of power produce no echoes outside of the local news media. The New England Journal and Dr. Robert Steinbrook have dealt the anechoic effect a mighty blow.
[In other news about Guidant's troubles, also note that the New York Times has just reported that Senator Charles E. Grassley, Chair of the Senate Finance Committee, may have his committee review the recent Guidant recalls; and the Times also reported that Guidant's recommendations for correcting problems with some of its ICDs by reprogramming them might not prevent the devices from failing, and that Guidant has yet to come up with an alternative solution, other than removing and replacing these devices.]
No comments:
Post a Comment