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Heart Device Maker Stayed Silent on Defects, Critics Claim

Guidant under fire for "foot-dragging" over recalled implantable defibs

WEDNESDAY, July 20, 2005 (HealthDay News) -- On March 14, 21-year-old college student Joshua Oukrop collapsed and died suddenly while on a bike trip with his girlfriend in Utah.

Oukrop's team of physicians in his home state of Minnesota were "stunned" by the sad news.

Four years earlier, those doctors had helped treat the teenaged Oukrop for a dangerously enlarged heart, a condition called hypertrophic cardiomyopathy. As part of that treatment, he received a state-of-the-art, implantable cardioverter-defibrillator (ICD) to prevent sudden, potentially fatal arrhythmias associated with the condition.

Oukrop's ICD was the Ventak Prizm 2 DR Model 1861, made by Indianapolis-based Guidant Corp. The device is now part of a massive recall along with two other models, spurred in large part by the death of Oukrop and one other patient.

In an article in the July 21 issue of the New England Journal of Medicine, Oukrop's doctors at the Minneapolis Heart Institute Foundation report that after the young man's death they scoured the FDA's adverse events database and found other, similar instances where the ICD in question had short-circuited and then silently disabled -- leaving patients like Oukrop vulnerable.

This was worrisome: 47 other patients under the team's care had received the same device.

One of the physicians, Dr. Barry Maron, recalled a conversation with four Guidant officials that took place in May. He asked them, "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,'" Maron told the journal. According to Maron, the Guidant officials said full disclosure to patients might only lead to confusion as to whether they should or should not replace the devices.

Maron, director of the foundation's Hypertrophic Cardiomyopathy Center, ignored their advice.

"We contacted each and every one of the patients," he said. "We got their names from Guidant and informed them of the situation and allowed them to make up their own minds as to what to do, with their doctor's consultation."

More disturbing to Maron was the disclosure, later on, that Guidant had first spotted a problem with the model in question as far back as February 2002 -- making appropriate manufacturing changes that same April. To date, there have been no reports of failure among devices manufactured after these changes.

While he stopped short of calling Guidant's silence a cover-up, the company's lack of action on the defective ICDs "was obviously foot-dragging," Maron said. "Clearly, they did not disclose this problem [to doctors or patients] for three-and-a-half years -- that's a fact nobody would dispute."

Attempts by Healthday to obtain comment from Guidant were unsuccessful. However, in a June 17 statement, the company admitted that "after making the manufacturing changes, Guidant sold products manufactured before the April 2002 change. At that time, data did not show an unusual failure rate and Guidant believed the device to be reliable."

On July 1, the FDA issued its highest-level, "class 1" recall for three Guidant ICDs: all Ventak Prizm 2 DRs manufactured before April 2002, as well as two other ICDs with reported failures, the Contak Renewal H135 and Contak Renewal 2 Model H135. The FDA issues such a recall when it has concerns that "a malfunctioning device will cause serious adverse health consequences."

Under the terms of the recall, patients can have their ICDs switched to a replacement model provided for free by Guidant.

According to the journal article, more than 20,600 ICDs covered by the recall are currently implanted in patients worldwide.

"There's no question that there are a lot of these devices out there," said Dr. Anne Curtis, president of the Heart Rhythm Society, a professional group representing arrhythmia specialists that is currently drafting guidelines aimed at providing better oversight for ICDs and related devices.

She stressed that "the overwhelming majority of these things work fine and continue to work fine. The problem is if there is a rare problem, though -- which patient, at which moment, is that going to happen in?"

She said patients have to weigh their options carefully, weighing risks and benefits. "When you change out a cardiac device, there's a slight risk of infection," she said. "Generally speaking, that's under 1 percent, but let's say the risk of infection is 0.5 percent and there's a problem with a device that occurs 0.1 percent of the time -- then you might be better off following the patient over time."

Maron added that, in the case of the defective Guidant devices, young patients, especially, may opt to have theirs replaced. He explained that not only will they be wearing them the longest, but young users also tend to have heart conditions "that probably place them at highest risk, as well, or they wouldn't have had the device" implanted to begin with.

Curtis says the Heart Rhythm Society has scheduled a policy conference on ICD oversight issues for Sept. 16 in Washington, with representatives from the FDA and industry also in attendance. But the NEJM article points out that the society relies on industry for about a quarter of its funding, including funds from Guidant and other device makers, "arousing concern about potential conflicts of interest."

Curtis dismissed those concerns. "Our interest is in patient safety, and that's what we want to make sure, plain and simple," she said. "There's no value to us behaving in any other way."

The FDA has also come in for criticism for what some see as weak oversight. "It gets back to their [post-marketing] surveillance techniques, which turned out to not be very friendly or workable," Maron said. He believes the agency's Manufacturer and User Facility Device Experience (MAUDE) database "really provides no useful information."

FDA spokeswoman Julie Zawisza said the agency "agrees that it is important to communicate important safety issues to physicians and patients at the earliest possible opportunity, so that decisions can be made in the best interests of patients." She added that the FDA plans to "continue to monitor devices once they are on the market to ensure their continued safety."

In the meantime, Guidant's corporate woes continue to mount. In December 2004, Guidant -- which posted 2004 sales of nearly $4 billion -- was acquired by Johnson & Johnson. Just last month, however, Guidant and its executives became the focus of a securities fraud case that alleges the company covered up the ICD problems.

And on Monday the company issued a "physician communication" warning of faulty seals on nine older-generation implantable pacemakers, all of which "have not been sold or implanted for the past four years," according to the statement. The company goes on to say that it had informed the FDA of the action "and FDA may classify this action as a recall," which it has not yet done.

All this corporate drama shouldn't obscure the fact that devices meant to save lives may now be putting them in peril, Maron said.

In the case of the device worn by Joshua Oukrop, "it's an unpredictable defect. These are young people who are given ICDs with the expectation that they needed them to preserve life," he added. "But if you have a defective device, and unpredictably so, then it's as if you have no device at all."

More information

For more on the ICD recalls, head to the Heart Rhythm Society.

SOURCES: Barry Maron, M.D., director, Hypertrophic Cardiomyopathy Center, Minneapolis Heart Institute Foundation; Anne Curtis, M.D., professor, medicine, and chief, cardiology, University of South Florida, Tampa, and president, Heart Rhythm Society; Julie Zawisza, spokeswoman, Food and Drug Administration; July 21, 2005, New England Journal of Medicine; July 18, 2005, news release, Guidant Corp.
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