Sunday, July 03, 2005

Don't Ask, Don't Tell: Health Affairs Interviews Guidant CEO Ron Dollens

Health Affairs, which bills itself as " the leading journal of health policy thought and research," just published a lengthy (18 page in the PDF version) interview of Guidant CEO Ronald W. Dollens by Founding Editor John K. Iglehart. The interview was notable for the interviewer's extreme deference to the interviewee, and more for what the interviewer didn't raise that what he did.

The Case of Guidant's ICDs

An accompanying editor's note stated, "On May 24, 2005, one month after the interview that follows was conducted (25 April), the New York Times reported that an implantable cardiac defibrillator (ICD) sold by the Guidant Corporation had failed to operate properly while a twenty-one year old college student who had the device implanted in his chest was suffering a cardiac arrest. The student later died. Following the Times report, John Iglehart posed an additional question...." Furthermore, the note stated that Guidant had issued a press release on June 17, 2005, that Guidant was "volunatarily advising physicians about important safety information regarding certain devices [three ICD models]"; and that the Associated Press quoted a US Food and Drug Administration spokesman as saying "This is a voluntary recall." It also noted that Guidant confirmed reports of 45 failures of ICDs out of 63,000 implanted worldwide. Finally, the note quoted Dollens, "Patient safety is paramount and our highest priority."
The question that Iglehard asked Dollens about this issue was:
  • "A recent New York Times story, which focused specifically on ICDs, raised broad questions relating to the inherent risk associated with invasive procedures and the understanding of various groups of risk. Could you share with us your thoughts on the specific issues addressed in the Times article?"
Dollens replied,
  • "The article focused on the communications issues surrounding the continuous evaluation of patient risk when using novel, life-sustaining medical technology. We encourage public debate and discussion about the pros and cons of broader dissemination of infomation about product safety. Guidant looks forward to participating in that discussion."
This interview and the accompanying editor's note, however, left out some important information. In particular, the New York Times article of May 24 reported not only on the failure of the defibrillator that was associated with the death of the young patient, but also that Guidant had known for three years of a flaw in the design of that particular defibrillator, the Ventak Prizm 2, that could cause the unit to short-circuit and fail, and that the company had made changes in its manufacturing process three years earlier to correct this flaw. We posted about this New York Times article on Health Care Renewal, and concluded, " there seems to be no good excuse to hide data about this device's flaws from the public and from doctors."
Furthermore, there was other news about Guidant that appeared after the May 24 but before the June 17, 2005 press release. On June 2, the New York Times reported that Guidant continued to sell ICDs from stock manufactured before the flaw was corrected after it had started manufacturing an upgraded version that corrected the flaw. (See our post here.)
A day after the Guidant press release, the New York Times published another article disclosing flaws in additional models of Guidant ICDs, that Guidant had also failed to previously disclose these flaws to doctors as soon as it knew of them, and also that Guidant continued to ship the old version of these models of ICDs from stock after it started manufacturing new models which corrected the flaw. (See our post here.)
Thus, the prominent, lengthy interview in Health Affairs of Guidant CEO Dollen, done by the most senior Health Affairs editor, avoided mentioning most of the serious criticisms made of how Guidant handled the problem of faulty ICDs. Iglehart characterized the problem only in the most general terms, and allowed Dollen to provide an answer that was equally vague. Although the editor's note suggested that Health Affairs editorial personnel were aware of news about Guidant made public from May 24 to June 17, 2005, it failed to mention that the news after May 24 had raised additional issues about Guidant ICDs.

The Case of the Ancure Endograft System

Iglehart asked Dollens to opine about such diverse matters as "the era of evidence-based medicine," how Guidant provides health care coverage to its employees, and how "the American way of delivering and financing health care is flawed." Yet he never mentioned another serious problem in Guidant's past that eerily presaged the ICD problem.
In 2003, Guidant agreed to plead guilty to multiple felony counts for hiding, as the New York Times put it, "serious health problems, including 12 deaths, caused by one of its products." Guidant agreed to pay over $90 million in civil and criminal penalties, the largest fine ever paid by a device-maker for concealing problems with one of its products.
In summary, the facts reported by the Times in 2003 were as follows. In 1999, Guidant began marketing a new type of aortic graft that was inserted via a catheter, the Ancure Endograft System. Soon after the device was marketed, physicians who inserted it began complaining that the device would be become lodged prior to achieving correct positioning, requiring abdominal surgery to repair the problem. Guidant sales represented began instructing doctors to break the device into pieces and then extract them, even though this method had never been clinically tested, and despite the sales representatives' lack of qualifications to give such clinical advice. Guidant eventually reported 172 reports of problems with the device to the FDA, but later prosecutors charged that Guidant had concealed more than 2000 of the the reports it had received. The FDA heard of the scope of the problem in 2000 after seven anonymous whistle-blowers sent it a letter. Guidant pulled the aortic graft system off the market in 2001, and then revealed it had received thousands of reports of problems with the device. (See summaries of other news articles here, but most original articles are no longer on the web.)
Yet the Iglehart interview never mentioned the case of the Ancure Endograft System, which was undoubtably important, and seemed relevant not only to the more recent case involving ICDs, but indicative of the extent that Guidant really regards safety as "paramount."

In Summary

A prominent editor of a prominent health policy journal devoted considerable effort to and published considerable pages of an interview with the CEO of a large device manufacturing firm, yet avoided asking skeptical or probing questions about a current problem that raises substantive concerns about the quality of the company's products, and even bigger concerns about how the company has dealt with quality problems. The interviewer avoided asking any questions about a similar case from a few years ago.
This is only one article, but it seems to indicate how deferentially the health services and policy literature may treat leaders of large health care organizations. This literature is a major source of information about the health care system and health care policy for physicians, researchers, and policy-makers. While it may show deference to leaders of large organizations, however, this literature often includes pointed criticisms of physicians.
Here is another example of the "anechoic effect," the curious lack of echoes resulting from cases that show the down-sides of concentration and abuse of power.
But to fix these problems, we will at least have to start talking about them.
To help us do that, journals about health services and health policy should begin to show skepticism of the powers that be befiting these journals' scholarly aspirations.

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