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January 28, 2006

Left to One's Own Devices: Adverse Event Reporting
My plan for today was to shift away (finally!) from the all-consuming who's-buying-who (whom?) story of the past two weeks, and get to something far more important: the health and safety of patients who are the recipients of these manufacturers' devices. As it turns out, however, my agenda has intersected with "the big story". More on that in a minute.

Iowa -- the day after Thanksgiving 2005. Darrell has 3 Cypher stents implanted. Five weeks later he breaks out in an unbearable burning itchy rash. It doesn't go away. His doctors and cardiologist have no answer. His wife suggests that he go on the internet to search "stent allergies". He winds up on our Forum (the first hit) and realizes that he is not alone; many other patients have experienced similar symptoms. He writes: "I should listen to my wife more often."

At Angioplasty.Org's Patient Forums, we've been getting increasing numbers of postings from patients who are having problems. Our top four "complaint" topics have almost 500 postings. Call us a mini-MAUDE database, if you will, but we're compiling a significant number of "adverse reports". And we have the feeling that many of these anecdotal incidents are not being reported to the FDA. The recent JACC study "Hypersensitivity Cases Associated With Drug-Eluting Coronary Stents" agrees that these reactions are under-reported by the device manufacturers, patients and physicians. We'd assume this applies across the board.

The U.S. Food & Drug Administration also agrees. The FDA Center for Devices and Radiological Health (CDRH) recently announced a Postmarket Transformation Initiative to "transform and strengthen the way it currently monitors the safety of medical devices after they reach the market" -- more of a "real world" observation than what is seen in tightly-controlled clinical trials. We applaude this effort.

But we would also like to see the device manufacturers be proactive and take the initiative to help the real end-users of their devices -- the patients. Terrie from Ohio's husband started exhibiting all the symptoms noted in the JACC article and, until she found our site and its link to the study, got no answers -- from her doctors or from Cordis (in fact Cordis spokesman, Chris Allman, disputed the conclusions of the JACC study to the Chicago Sun-Times, calling it "pretty speculative"). And I don't mean to single out Cordis; in the "stent allergy" Forum, we've gotten postings from Taxus recipients as well.

In the good ol' days of angioplasty, Andreas Gruentzig & Co. compiled as much data as they could. They were not so concerned with the value per shareholder as they were "possessed with the adventure", as Richard Myler called it, of finding out how this procedure could help patients. Unfortunately, in today's environment, what should be important concerns about devices are getting drowned in what vascular surgeon Sir Peter R. F. Bell characterized to me as "a tidal wave of dollars".

If but a miniscule percentage of the billions of device dollars that were flying through the columns of the Wall Street Journal last week could be spent on really understanding how these new and revolutionary treatments are affecting patients in the "real world", and in helping them understand complications, if there are any. Yet, these same device companies have reduced, not increased, their expenditures on that non-revenue-friendly activity of patient education.

Which brings me to the intersection of agendas. As the sun was rising on January 25, Boston Scientific and Guidant penned their agreement, announcing it to an anxious financial world at 7:02am; ten hours later, the FDA faxed a warning letter to Boston Scientific -- a stern company-wide admonition that, among a number of other cautions, took them to task for late or non-reporting of 145 adverse incidents involving a range of devices. The FDA was upset because previous warnings had gone unresolved. And why are these reports about patient experience so important? As Daniel Schultz, director of the CDRH, told the Pioneer Press:

"That is part of the feedback loop that is critical for use to evaluate and recommend changes in devices to make them more safe and effective."

The letter stated that most future approvals would be on hold until the issues were dealt with. Boston's stock got hammered and went down almost 7% which, according to some analysts, might threaten to unravel the Guidant deal.

So, alas! My entry about patient safety and adverse event reporting winds up discussing, yet again, its impact on the "big deal".

But after all, that's what it's about: safety and money.

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