This is the eighth and final posting in a series in which I present evidence about the ill effects of some drugs and medical devices, the ways these Killer Meds are pushed by those who profit from them, and the reasons the FDA is neglecting its regulatory duties. I thought I had done my share about alerting my fellow citizens to the need for major changes in the ways medications are tested, marketed, and regulated. [See previous postings here: See previous postings here: Part I: Zyprexa, Part II: Baycol, Part III: Guidant, Part IV: Posicor, Part V: Redux, Part VI: Vioxx, Part VII]
But then the headlines brought the concerns about unduly risky medications much closer home, in effect right into my chest and heart.
In mid-2006 my heart, long affected by irregular heart beats, went yo-yo. It often was racing much too fast. Given medications to slow down the rate, the heart was beating dangerously slow. The docs recommended a pacemaker. I called a relative who is a cardiologist for advice. He urged me to go for it, but warned me not to use the one marketed by Medtronic. Although he admitted that he had no positive proof about the defects of the device, he told me that what he heard in the corridors left him uncomfortable.
When I told the associate of the cardiologist treating me at the hospital (the chief guy was otherwise occupied) that I was ready to proceed but wanted to have a different brand implanted in me, he looked at me as if I had just asked him personally to peel an orange, and serve it with a knife and fork. But he said nothing. The next morning, I learned that I was the dubious beneficiary of a Medtronic pacemaker, implanted in my chest, wires sticking into my heart.
Fast forward to Oct 30, 2007. The headlines informed me, and many thousands of others, that one of the Medtronic pacemakers is giving people painful, unnecessary, gross shocks, in some cases as many as 14 times an hour! Moreover, I learned that the company that markets the device, Medtronic, ignored this information for almost a year, before it decided to recall the device. Most troubling, "recalling" a pacemaker is a cruel joke. They can be recalled if and as long as they have not been implanted. Once they are in place, the leads (the wires that run from the device implanted in the chest and into one’s heart) cannot be removed without posing serious danger to the patient. And—it turns out— as the source of the problem is that these leads themselves break down, rather than the device itself.
Not only was the recall unduly delayed, but the device was never properly tested because FDA regulations for devices are much less demanding than for medications, where —we have seen – they are still far from adequate.
My heart (at least as far as the three dimensional, physical entity is concerned) is not affected. Turns out that the culprit is a device called Sprint Fidelis 6949; mine has some other number. However, I cannot but wonder if what is bad for the goose can be good for the gander. And above all, my heart does go out to all my fellow patients—many thousands of them—who have the defective device implanted in the body, and cannot remove without risking their lives. I am especially furious on behalf of those who had the device inserted after it was found out to be unsafe, although those who had it implanted before it was properly tested also have a beef.
Above all, the issue runs way beyond this or that device or medication. It concerns the ways we are treated by a heartless system, and raises the question: why no voice? Why we do not hear from our elected officials and those who aspire to their posts on this vital matter?
Amitai Etzioni is University Professor at the George Washington University and, most recently, the author of Security First: For A Muscular, Moral Foreign Policy (Yale, 2007).