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New York Times
By BARRY MEIER
March 21, 2006
Reviewers Cite Flaws at Guidant
An expert panel commissioned last summer by the Guidant Corporation to review its handling of heart device flaws said yesterday that the company had systematically failed to fully assess patient safety in deciding whether to publicize product failures.
The group found that decisions made by Guidant about how to address or disclose product problems were driven by statistical projections from engineers rather than assessments from doctors about the medical consequences of those failures. The group urged Guidant to create an outside panel of physicians and others who would regularly monitor the safety of its devices and advise the company about when and how to notify doctors and patients about problems.
In May, Guidant found itself at the center of a growing debate after it was disclosed that the company had not told doctors for three years about an electrical flaw in one of its defibrillators, an implanted device meant to interrupt a potentially fatal heart rhythm. Company executives defended their actions by maintaining that the device met all engineering projections and by asserting that notifying doctors about the flaw might result in more patient harm than good by causing unnecessary surgery to remove the devices and replace them.
The 12-member panel appeared to sharply reject Guidant's arguments, concluding that defects that posed significant risks to patients needed to be promptly disclosed, even when they occurred in small numbers.
"The Independent Panel believes that under no circumstances should a potential or manifest risk of a preventable death be superseded by statistical analyses that indicate that performance remains with general guidelines," the panel concluded.
At least seven patients have died in episodes in which Guidant defibrillators failed to work because of an electrical defect.
In a statement yesterday, James M. Cornelius, the chief executive of Guidant, which is based in Indianapolis, said it and other makers of heart devices recognized that the environment governing the disclosure of product problems had changed.
"We are taking the necessary steps to improve surveillance of device performance and safety, as well as physician and patient communications," Mr. Cornelius said.
The problems with Guidant defibrillators came to light when The New York Times reported in May that the company had not publicized the electrical defect in a defibrillator known as the Prizm 2 DR. The company also continued selling potentially flawed devices out of inventory in 2002 even after an improved version was available. The panel's report found that 4,000 such devices had been implanted into patients.
The Food and Drug Administration soon began an investigation. Guidant subsequently disclosed that two other defibrillators, the Contak Renewal 1 and Renewal 2, had a similar electrical problem. Over the summer, Guidant issued recalls affecting those models and tens of thousands of other units. The Justice Department is investigating Guidant, which recently said it faced about 145 lawsuits over the units.
In the midst of last summer's turmoil, Guidant announced that it would sponsor an outside panel to review its handling of issues related to product safety and defect disclosure. That panel, headed by Dr. Robert J. Myerburg, a professor of medicine at the University of Miami, was composed principally of cardiologists, along with experts in areas like medical ethics and statistics.
Yesterday, Guidant provided a copy of the panel's executive summary and recommendations to The Times. The company plans to post the group's full report today on its corporate Web site.
In a telephone interview yesterday, Dr. Myerburg said the group had found that both the quality of Guidant's devices and the capability of its engineers were at least equivalent to those of its competitors. But Dr. Myerburg said that the review had also discovered that decisions on how to assess product defects were made by Guidant engineers rather than medical experts.
As a result, Guidant officials could claim that a device's performance fell within engineering limits without considering the medical consequences of product failures, he said.
"There was no medical input to speak of" in the review process, Dr. Myerburg said.
He said that 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 also found that top executives of Guidant did not routinely seek out product safety information.
Dr. Myerburg also said the panel failed to find evidence to support Guidant's claim that the risks posed by surgery to replace the devices, like infection, were enough to justify not telling doctors about defects that posed risk of death or serious injury.
"The panel would not agree with the statement that the risks of replacement is a reason for not going public," he said.
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. Studies have found that only a relatively small number of device failures are reported to manufacturers and the F.D.A. because doctors and hospitals do not always report such problems and because devices are not usually inspected after heart patients die.
A major medical group, the Heart Rhythm Society, also plans to release a report soon that is expected to call for widespread changes in, among other things, how data about heart device failures is collected and disclosed to doctors. In recent months, Guidant has taken several steps to address the types of disclosure issues raised in the panel's report. For example, it and its two principal competitors, Medtronic and St. Jude Medical, have started providing more detailed product performance data to physicians.
In January, Guidant agreed to be acquired by Boston Scientific for $27 billion. Executives of Boston Scientific said they were considering changing the name of Guidant's heart device as part of a plan to rebuild physician confidence in its products.
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