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Todays front page of the NY TIMES!

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Lisa Salberg Find out more about Lisa Salberg
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  • Todays front page of the NY TIMES!

    NY Times article

    We actually get so see Pam! check out this link.

    Lisa


    --------------------------------------------------------------------------------

    June 20, 2005
    Defective Heart Devices Force Some Scary Medical Decisions
    By BARRY MEIER
    For Pam Alexson, the decision whether to have a potentially defective heart device removed and replaced was easy. Ms. Alexson, a former nurse in Rehoboth, Mass., who expects to undergo surgery tomorrow, has the same Guidant Corporation defibrillator that failed in a college student who died in March, as well as the same type of genetic heart disease that killed him.

    But another heart patient with that Guidant unit, Douglas Parsons, said he was holding back, not because he did not want the device out, but because his history of infection pointed to a bigger risk from surgery .

    "I feel like I'm stuck between a rock and a hard spot," said Mr. Parsons, a 62-year-old retired high school teacher in Oneonta, N.Y. "I would like to have it removed but I can't take that risk."

    In coming weeks, thousands of patients and their doctors will be weighing competing risks as a result of Guidant's decision last week, after urging by the Food and Drug Administration, to recall about 29,000 defibrillators that can potentially short-circuit when they are needed. Defibrillators emit an electrical jolt to restore rhythm to a chaotically beating heart.

    Each assessment on surgery, doctors say, will be a personal one, based on a patient's age and health, how dependent the patient is on the device and the patient's attitudes toward risk.

    Already, however, some patients like Ms. Alexson and Mr. Parsons are sharing a similar emotion: a sense of betrayal that Guidant did not disclose the problem earlier so that some people might have been spared the tough choice they now face.

    Guidant did not tell doctors for over three years about the electrical flaw in one model, the Ventak Prizm 2 DR Model 1861, that it has recalled. It also kept selling older versions of it after developing a version not prone to short-circuiting.

    The problems may soon take another toll on Guidant. Johnson & Johnson, which agreed in December to buy Guidant for $25.4 billion, is trying to determine, among other things, whether the issue could materially hurt Guidant's business, said several people involved in the acquisition talks. Under the terms of the deal, such a determination could allow Johnson & Johnson to pay less for Guidant or walk away, although these people said that scuttling the deal was a far less likely outcome.

    A spokesman for Johnson & Johnson declined to comment yesterday. Phone calls and e-mail messages to Guidant were not returned yesterday. On Friday, Guidant announced that it was recalling the Prizm 2 DR and two other models, the Contak Renewal and the Contak Renewal 2, because they could also potentially short-circuit.

    While problems with the Prizm 2 DR became known last month, the announcement about the Renewal models was the first indication that they had also repeatedly short-circuited.

    Several people with Guidant units said that when they heard about the troubled implants they reached into their wallets and pulled out a card that identifies the make and model of the device they carry inside. For those who found a match, the feeling was quick and sinking.

    "My first reaction was a little bit of panic," Mr. Parsons said.

    The surgery to replace a defibrillator, which is the size of a pager and is implanted under the skin of the upper chest near the shoulder, takes an hour, and many people go home immediately afterwards. Full recovery takes about 7 to 10 days. But like any surgical procedure, the surgery carries a risk of infection.

    About 17,000 people, 13,900 of them in the United States, are still implanted with the affected Prizm 2 DR devices, which are those made before April 2002, when Guidant fixed the problem. Another 11,900 people, 6,700 of them in this country, still have the affected Renewal devices, made before last August. The Renewal devices - more complex defibrillators intended for patients with severe heart failure - have pacemaker functions for both sides of the heart.

    It is not uncommon for medical devices already implanted in people - products like artificial hips, breast implants and pacemakers - to be recalled. Such recalls reflect an acknowledgement by a company and the F.D.A. that a device poses either a new type of risk or an increased level of a known one. At times, a company might issue a recommendation about what to do, but ultimately patients and doctors must decide whether or not to take them out.

    Doctors hardly make uniform decisions about whether to take out a problem heart device, said Dr. William H. Maisel, a cardiologist at Brigham and Women's Hospital in Boston who has studied how physicians react to recalls. And many doctors are just now sorting out what to do regarding the Guidant units.

    Dr. Jeffrey Rottman, a professor of cardiology at Vanderbilt University in Nashville, said that one important factor in the replacement decision is whether a patient has already experienced cardiac arrest, as opposed to receiving a defibrillator as a precautionary measure. Along with a patient's age and medical history, another important issue is how each patient views risk.

    "Some people think they are going to win the lottery, and some people think they are going to be struck by lightning," he said.

    Nancy Hanner, a retired real estate agent who lives in Skaneateles, N.Y., is a lottery type. Ms. Hanner, who received a Prizm 2 DR in 2001 as a precautionary measure, says she never worries about her health and does not feel like taking time off to have the unit replaced until she has to. Defibrillators need to be replaced every five or six years because their batteries drain.

    Her heart problem has also never caused the defibrillator to fire. "I've just joined a golf and tennis club, and I don't want to give it up" to have an operation, she said.

    Ms. Alexson, the former nurse, faces a far different situation. She has a genetic heart disease called hypertrophic cardiomyopathy that can cause sudden cardiac arrest, and she received her defibrillator in 2001 to protect her against the condition.

    But reports about the March death of a 21-year-old college student, Joshua Oukrop, whose Prizm 2 DR failed, have been enough to destroy her trust both in the device and in Guidant, she said.

    While Guidant has offered patients a free replacement unit, Ms. Alexson plans to get one made by a competitor, Medtronic Inc., and battle out the financial issues later. "I can't trust these people who sit around in their offices and decide whether I'm going to live or die," she said

    In recent days, people like Ms. Alexson with the affected Guidant devices have been scrambling to get information about them from the company and from patient advocacy groups and Web sites that deal with defibrillator-related issues. (Some patients interviewed for this article were contacted through such forums.)

    Mr. Parsons said that after receiving a defibrillator several years ago, he developed a staph infection on the device and its electrical leads, and as a result he had to undergo emergency open-heart surgery. Since hearing about the Prizm 2 DR problem, he has been discussing the pros and cons of replacing it with his doctor.

    They have decided that given the last infection, the surgical risks outweigh those posed by the device. But Mr. Parsons has another problem. Along with the defibrillator's shock, he is also dependent on its pacemaker function. And if that fails, he worries that he might not get to a hospital in time for treatment.

    "If it does short-circuit, I am pacemaker-dependent, so it would put me in grave distress," he said.

    Andrew Ross Sorkin contributed reporting for this
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

  • #2
    "I can't trust these people who sit around in their offices and decide whether I'm going to live or die," she said
    Yea! Pam!! Right on. I hope I never need a device, but if I do, you bet your bippy that it won't be a Guidant device.

    Good luck with the procedure!

    S

    Comment


    • #3
      Woo hoo!

      We have a celebrity amongst us... way to go, Pam!

      @Sarah... omg how long has it been since anyone's used the word "bippy" outside of Laugh-In reruns? LOL. You are too too funny.

      Jim
      "Some days you're the dog... some days you're the hydrant."

      Comment


      • #4
        Looks like Pam has hit the big time! She may well need a press sec. if she has one more day like today... several news outlets, radio, TV and AP print have contacted her for more information.

        INFORMATION IS POWER and Pam is our POWER PLANT today! So many people will be informed about the recall and HCM thanks to her.

        I know a few others may have also been in touch with the press in the past week or so. Keep up the great work guys!

        Lisa
        Knowledge is power ... Stay informed!
        YOU can make a difference - all you have to do is try!

        Dx age 12 current age 46 and counting!
        lost: 5 family members to HCM (SCD, Stroke, CHF)
        Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
        Therapy - ICD (implanted 97, 01, 04 and 11, medication
        Currently not obstructed
        Complications - unnecessary pacemaker and stroke (unrelated to each other)

        Comment


        • #5
          Nice job Pam.
          Cleveland Myectomy Club
          August 31, 2004

          Comment


          • #6
            Thanks eveyone,

            Yes it has been a day beyond description!! In between a doctors visit , a nutritionist visit and a closed group session of candidates for gastric by- pass surgery, I heard word of what I could not have imagined what was about to occur.

            I was on the expressway headed for NEMC and recieved the first call that I made the front page of the New York Times. I arrived in Boston went to the gift shop and purchased the paper. I thrilled the young man at the counter as he caught that I was the one on the front page. The phone calls started. Dear Lisa had an AP reporter who wished to talk to me. Lisa and I had a nice chat and she said I looked great( make-up helps ) the photagrapher said I could not smile as "It is a serious topic."

            I barely had time to call The AP back when talk radio host Lana Jones for WBZ called. Then NECN,( New England Cable Network) called. Then channel 5 WCVB, then CBS channel 4 and the 3 TV networks wanted live camera interviews. They all wanted me to do the hollywood walk away at the end of each interview. ( just the nonchalant walk by the camera without looking at the camera as he is almost in your face.) By the third time the reporters said have you done this before? ..." Who me I must be a natural."

            Finally I get on the expressway south.,3:41pm( was in Boston from 10 AM on. ) Arrive home, my new celebratory has brought the family home to root me on . My local paper calls and wants to do an interview with camer man. 7:30- 9 pm and then home to my house , a snack and then a shower , I will be in bed and NPO( nothing by mouth ) after midnight to be ready to arrive at the APC at Rhode Island Hospital for 7 AM for the defibrilator change out tomorrow.

            Whewyyyy hold the paparrazi back please they will probably be at the hospital tomorrow as RI stations Channel 10 and 12 have not contacted me yet. Of course , I asked the Associated Press reporter what news paper I could check , she said , "excuse me?'' I repeated my question , now realizing what an error I had created in asking such a stupid question and by now realizing the answer. She said, " mam,,,,, the world." She said, Ms Alexson, you make the front page of The New York Times , people want to know who you are and what you have to say."

            It's mind boggling to say the least.

            All I can write for now , will update you all/ Lisa as I am able following the surgery tomorrow. I have touted the HCMA as best I can and defined it and our disease so much , I sounded like a recorder.

            Wish me well... Nighty nite.

            Pam
            Dx @ 47 with HOCM & HF:11/00
            Guidant ICD:Mar.01, Recalled/replaced:6/05 w/ Medtronic device
            Lead failure,replaced 12/06.
            SF lead recall:07,extracted leads and new device 2012
            [email protected] Tufts, Boston:10/5/03; age 50. ( [email protected] 240 mmHg ++)
            Paroxysmal A-Fib: 06-07,2010 controlled w/sotalol dosing
            Genetic mutation 4/09, mother(d), brother, son, gene+
            Mother of 3, grandma of 3:Tim,27,Sarah,33w/6 y/o old Sophia, 5 y/o Jack, Laura 34, w/ 5 y/o old Benjamin

            Comment


            • #7
              Ohmigosh, Pam. You're the best! I'm glad you've had the energy to take on all the papparazzi today. You take care and I hope and pray tomorrow goes well.

              Reenie
              Reenie

              ****************
              Husband has HCM.
              3 kids - ages 23, 21, & 19. All presently clear of HCM.

              Comment


              • #8
                Hooray for Pam! Good luck tomorrow. Take it easy and keep us posted.

                Wow. The NYT!

                -Jim- LOL. Yeah, I am a fan of archaic words.

                Comment


                • #9
                  Pam, You've been a great voice for the HCMA and all others affected. I'm thinking of you today, wishing you a speedy and uncomplicated recovery. Take care of yourself! Linda

                  Comment


                  • #10
                    Way to go Pam!!!!!!!!

                    I'm thinking about you and yes as always you are in my prayers

                    Shirley
                    Diagnosed 2003
                    Myectomy 2-23-2004
                    Husband: Ken
                    Son: John diagnosed 2004
                    Daughter: Janet (free of HCM)

                    Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9

                    Comment

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