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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).

www.securityfirstbook.com

Originally posted to Amitai Etzioni on Mon Dec 03, 2007 at 01:16 PM PST.

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Comment Preferences

  •  Best wishes for your health, professor (11+ / 0-)

    By the way, do you read the other diaries here on the health care system, most notably by nyceve?  Your input would no doubt be welcome and you might find them of value.

    If somebody writes a book and doesn't care for [its] survival, he's an imbecile. U. Eco. (P.S.: my opinions are mine, not my employer's.)

    by Major Danby on Mon Dec 03, 2007 at 01:23:56 PM PST

  •  I missed your earlier diaries (3+ / 0-)
    Recommended by:
    Avila, nyceve, Fabian

    but I just took a quick glance at the one on Zyprexa. I have to say that while I am fully on board with open, honest, and ethical marketing of medications and other medical products that my personal observations of Zyprexa in a family member have made me a HUGE fan of the medicine. It works wonders.

    There are potential problem side effects with all meds. Doctors, patients, and others involved ought to be fully informed of the potentialities and ought to be sure to monitor such things.

    But let me say again that my observation is that Zyprexa is a life saving medication that is worth risking potential side effects for many patients that need its benefits.

    Peace,

    Andrew

    "Parlimentary inquiry Mr. Speaker... does whining come out of my time?"

    by Andrew C White on Mon Dec 03, 2007 at 01:23:59 PM PST

  •  No wonder my broker told me to (2+ / 0-)
    Recommended by:
    Avila, Fabian

    sell some of my Medtronic stock.  I'll have to read your series.  I am always at odds with my doctors about taking pills, pills, pills.  At present I am only on one - for blood pressure but am working real hard on my diet and exercise.  

    Also I occasionally take a valium and my young doc got all nervous - something about fits of some kind.  Since I take one very seldom - it doesn't worry me but really we should all be careful of what we take.

    Why we do not hear from our elected officials and those who aspire to their posts on this vital matter?

    Indeed!

    What's the plan? The plan is I go in and start hitting people in the face hard. (Angel, from the Series)

    by xanthe on Mon Dec 03, 2007 at 01:25:41 PM PST

  •  Well researched series (3+ / 0-)
    Recommended by:
    Avila, xanthe, Spathiphyllum

    Thanks for your efforts.  Better post-market surveillance is vital.

    Democrats give you the Bill of Rights; Republicans sell you a bill of goods!

    by barbwires on Mon Dec 03, 2007 at 01:27:56 PM PST

  •  So you specifically denied them permission (3+ / 0-)
    Recommended by:
    Avila, Spathiphyllum, fhcec

    to implant a Medtronic pacemaker and they did anyway?

    That's truly scary.

         Mind-boggled,
           Heather

    •  Monday morning quarterbacking... (3+ / 0-)
      Recommended by:
      Avila, xanthe, Chacounne

      but it's just a thought I'd share with you and maybe somebody will find it useful in the future.

      I understand you told the doctor NOT to use the Medtronic device, yet they did, anyway.  

      The suggestion is that if such an event takes place again, in addition to telling the doctor, when you sign the consent form for surgery, handwrite into the form "I do no consent for X device to be used." Or whatever the case may be.

      Informed consents are to protect the medical professionals, but there's no reason we can't write our own wishes onto the paper.

      Same thing goes for every medical form you sign.   I'm constantly crossing stuff out that I don't agree with, and then initialing it.  Usually it deals with the privacy stuff.  Nobody seems to notice that I do that.  Fine by me.

      Thank you for writing these diaries.  They're very important.

      Condi keeps saying: "Failure is not an option." What she should be saying is: "Competence is not an option."

      by gooderservice on Mon Dec 03, 2007 at 02:07:06 PM PST

      [ Parent ]

  •  Avandia. (1+ / 0-)
    Recommended by:
    Avila

    Just curious... do you plan to write a diary about Avandia?

    Condi keeps saying: "Failure is not an option." What she should be saying is: "Competence is not an option."

    by gooderservice on Mon Dec 03, 2007 at 02:07:52 PM PST

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