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Guidant May Face Senate Scrutiny

Jul 31, 2005 | Star Tribune

At first blush, it might seem a bit unusual that the chairman of the Senate Finance Committee has taken a sudden interest in a series of heart device recalls by Guidant Corp.

Though a big-money business, defibrillators and pacemakers hardly seem the purview of one of Congress' most powerful bodies.

But no one in the medical technology industry was terribly surprised this month when Sen. Charles Grassley asked the Food and Drug Administration (FDA) for documents relating to the recent recall of some 150,000 heart defibrillators and pacemakers.

As Grassley pointed out in two recent letters to FDA Commissioner Lester Crawford, his committee has jurisdiction over Medicare and Medicaid programs, which provides health insurance for more than 80 million Americans and often pays for the sophisticated devices.

In the past year, Grassley, 72 and a farmer by trade, has emerged an ardent critic of the FDA, which regulates the drugs and devices approved for use in the United States.

The Iowa Republican began conducting oversight of the embattled regulatory agency after concerns surfaced about how it handled the suicide risks of teenagers using antidepressants and the cardiovascular risks associated with the painkiller Vioxx.

Now Grassley has requested copies of annual post-approval reports for the models of defibrillators and pacemakers that were the subject of Guidant safety alerts in recent weeks. These reports, he said, are not available to the public, even though they might contain important performance data about the devices.

He asked Crawford to explain why these reports are not posted on the FDA's website, and whether the agency is reconsidering procedures for surveillance of devices once they're approved and widely available to the public.

Indianapolis-based Guidant, which makes its heart devices in Arden Hills, came under fire after the death in March of a 21-year-old Grand Rapids college student, Joshua Oukrop, whose heart condition was treated in 2001 with one of the company's defibrillators. It was subsequently revealed that his model of defibrillator had an electrical flaw that was remedied in 2002 action that was reported to the FDA.

However, neither Oukrop nor his doctors were told that he was implanted with a potentially faulty device until it was too late. Other physicians and patients were not notified until May of this year when his doctors went public with their concerns about the device.

The controversy raises questions about when doctors should be told about device malfunctions, and to what extent. Fred McCoy, president of Guidant's cardiac rhythm management business, said this week that it's clear doctors want more information and that the company is more than willing to provide it.

Asked specifically about Grassley's questions for the FDA, McCoy said in an interview that "Guidant is an open book. We'll follow that process wherever it leads, it's certainly not something we're concerned about."

Grassley also asked Crawford to describe the agency's disclosure policy regarding post-approval documents for devices not only for defibrillators and pacemakers, but for all devices.

The dissemination of post-approval information about drugs and possible harmful side effects has long concerned the senator. He declined, through a spokeswoman, to be interviewed.

"The job for Congress, the FDA and consumer advocates is to get to the bottom of drug safety procedures and figure out, once and for all, what it'll take to make sure Americans can trust what's in our medicine cabinets," Grassley said in a speech to the Consumer Federation of America last March.

"Better-informed patients and doctors can make informed decisions about whether a drug is right for them," he said.

Grassley has also questioned whether the FDA is too cozy with the pharmaceutical industry, and has called for changes that he says would bring greater responsiveness and transparency to the agency.

In that vein, Grassley and Sen. Christopher Dodd, D-Conn., have introduced legislation creating a publicly accessible national data bank of clinical trial information. In addition, the two have introduced a measure to establish an independent office for drug safety within the FDA that would regulate drugs once they're on the market. Both bills are pending.

Grassley's efforts have gained support from several consumer groups including Ralph Nader's Public Citizen, which has battled the FDA for decades.

"The FDA is getting direct cash, over $200 million a year, from industries [it regulates] and it has a very detrimental effect of the ability of the FDA to protect the public," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

Whether Grassley's recent request for device-related documents will result in committee hearings or legislation is unclear at this point. His spokeswoman said a decision about whether hearings will be held "will be made as the process unfolds."

Wolfe supports the idea of a public forum to discuss these issues. "I'm sure there are a lot more things that the FDA knows or that the company knows about the Guidant or many of these other disasters that would only come out if there's a public hearing where pointed questions were asked and the people answering them fearing perjury if they lied or gave incomplete answers," he said.

An FDA spokeswoman said Friday that the agency would "carefully consider" Grassley's request.


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