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unique evaluation of the Guidant situation

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  • unique evaluation of the Guidant situation

    taken from this website
    http://urielw.com/guidant.htm

    Heart Trouble
    by Uriel Wittenberg ([email protected])
    June 9, 2005


    Talk about bad luck.

    At 17, you start fainting and falling down at marching band practice or while playing softball. Since your older brother has been diagnosed with hypertrophic cardiomyopathy, a relatively common genetic disease which can cause abrupt, fatal cardiac arrest, your dad takes you to see Dr. Barry J. Maron, an expert on the condition and a leading proponent of implantable defibrillators -- devices which are surgically implanted under the skin of the chest and which shock a chaotically beating heart back into normal rhythm.

    Dr. Maron finds you've got the same disease as your brother and are at high risk. So soon afterwards, you undergo surgery and get a defibrillator implanted in your chest.

    Life goes on. College, hiking, snowboarding, bicycling.

    Who made the device that's now inside you? Guidant Corp., one of the largest makers of medical devices, with $3.8 billion in sales last year, almost half coming from implantable defibrillators.

    Oh, and also: The New York Times reports that Guidant's image is "still rebounding from an episode in which a former unit, Endovascular Technologies, pleaded guilty in 2003 to 10 felonies and agreed to pay $92.4 million to settle charges that it covered up deaths and other problems related to a [different] device that treated weakness in the main abdominal artery."

    You may or may not have known this. Anyway, during spring break last March, while on a bicycling trip in Utah with your girlfriend, you develop heart trouble. No big surprise there. That's what the device inside you is for.

    Unfortunately, the device doesn't do the job.

    Guidant inspectors, examining your defibrillator after your death (at age 21), conclude it malfunctioned because of a short-circuiting problem. Since the short circuit also destroyed the device's memory, they can't determine whether the failure occurred while you were in cardiac arrest or some time earlier. In fact, the device may have died without your knowledge a couple of months before you did.

    Of course, Guidant was unaware of this short-circuiting problem before your demise.... Right?

    Well, no. Guidant knew of 25 other cases in which the defibrillator was, as the Times reports the limited information available, "affected by the same flaw," though your death is the only one known. Guidant changed its manufacturing processes nearly three years before you died to fix the problem -- but didn't tell doctors or patients about the problem with units made before that.

    It's estimated that as of now, 24,000 people have a Guidant defibrillator inside them that was made before the manufacturing improvements that corrected the problem.

    Following your death and Guidant's investigation, Dr. Joseph M. Smith, a senior Guidant executive and chief medical officer of its cardiac rhythm management division, makes a presentation to your doctor, Dr. Maron. Maron asks Smith what Guidant plans to tell other doctors who've used the device for their patients, and later tells the Times what Smith's answer was: "The answer was nothing."

    Guidant's plans change on May 23, however, when it's told that the Times is preparing an article. At that point the company issues an advisory to doctors.

    The article, appearing the next day, includes one doctor's viewpoint on situations like Guidant's:


    Dr. William H. Maisel, who has studied how doctors respond to device alerts, said that companies considering an alert face competing concerns over the cost of replacement versus harm to their reputations. As a result, Dr. Maisel, a cardiologist at Brigham and Women's Hospital in Boston, said there was the potential for a "huge conflict of interest."
    [Excerpted from Maker of Heart Device Kept Flaw From Doctors, New York Times, May 24, 2005.]

    Concerns over replacement costs seem to have won the contest this time.

    But as far as you're concerned, that's all ancient history.


    * * *
    Could you forgive Guidant?

    Well, you're dead, so you're not forgiving anyone. Hypothetically though.

    You should remember, even in death, never to condemn anyone before hearing their side of the story. And Guidant's position sounds plausible, at least initially.

    Guidant claims that advising doctors would have served no purpose since, as that advisory they've now issued recommends, units should not be replaced because of the manufacturing flaw. Why not? Low risk of failure. Only 26 known cases of problems out of 37,000 units manufactured before the manufacturing fix -- a rate of .07%.

    The Times article reports the stance taken by Guidant's Dr. Smith:


    Guidant believed that it would cause more harm than good by publicizing the issue because replacement defibrillators might not perform as well and because surgery also posed risks. While fatalities during defibrillator implantation are extremely rare, the procedure poses an infection rate of about 1 percent.
    That seems sensible. Except -- does "replacement defibrillators might not perform as well" make sense to anyone? Don't things usually perform better after a manufacturing flaw is fixed?

    But the incurious Times leaves that puzzle unexplored.

    Anyway, is the company's position reasonable? 1% is a lot more than .07%. Moreover, that .07% device defect rate is further reduced by the possibility that a given device won't be needed at all by the patient. Say, for example, an at-risk patient has a 10% chance of entering a state in which he depends on his defibrillator to restore his heart. Then his risk of having a problem because of a short-circuited device is only 10% of .07%, or about 1 in 14,000.

    In addition, Guidant appears to have fully complied with the Food and Drug Administration's reporting regulations. It filed reports of individual problems with the device as it received them, and it reported the second of two manufacturing changes it made in 2002. (The company says it did not report the first 2002 change because it decided that F.D.A. regulations did not require the reporting of those "manufacturing enhancements.")

    So if you have a problem with the way things were done, your problem may be with the federal government and its regulators.

    A lot of folks are now upset with Guidant, saying the company should have informed doctors. Dr. Herbert Rakatansky, for example, a clinical professor of medicine at Brown University, writes that Dr. Smith's rationale (above) for not informing doctors


    is arrogant and demonstrates an ignorance of contemporary bioethics. Corporate paternalism is inappropriate. A decision about whether to replace a possibly defective defibrillator should be made jointly by the doctor and the patient after consideration of all available data.
    [Letter to Times editor responding to article; published May 31.]

    But why isn't this ire directed against the F.D.A.? The agency could well have regulations requiring companies to inform doctors when such defects are discovered. It could also have informed doctors itself, since it was notified of the individual problems as they occurred.

    But let's put aside the question of F.D.A. responsibility, since no one else seems to be talking about it, and concentrate on whether the attacks on Guidant are justified.

    Dr. Maron tells the Times he's angry about having been kept in the dark because (as the Times reports his position) "high-risk patients could suffer potentially catastrophic results."

    Permit me an aside: What extreme timidity is it that drives reporters to heap redundant qualifiers upon each other like this? How much bravery would it take to write, "high-risk patients could suffer catastrophic results," or even, "... could die"? Senator Hillary Rodham Clinton's recent comments on the news media are well taken (though she was referring to their fear of Republicans, not of powerful corporations):


    It's shocking when you see how easily they fold in the media today. They don't stand their ground. If they're criticized by the White House, they just fall apart. I mean, c'mon, toughen up, guys, it's only our Constitution and country at stake.
    [Quoted in "Senator Clinton Assails G.O.P. at Fund-Raiser," New York Times, June 7, 2005.]

    But is Dr. Maron right? The article makes the point more clearly elsewhere, in describing the position of Dr. David S. Cannom, who sits on Guidant's board of outside medical advisers:


    [Dr. Cannom] said that while risks posed by the device were small enough to argue against replacement in many patients, that calculus could shift substantially for high-risk ones.
    To modify our earlier example, suppose a patient has an 80% chance of needing his defibrillator at some point to save his life. Then his risk of dying because of the defect is 80% of .07%, or about 1 in 1,800.

    Moreover, as Dr. Maron tells the Times, the numbers reported to Guidant might understate the situation because product problems could go undetected or might not be reported.

    So maybe the risk of death due to the defect is 1 in 1,000. Compared to a 1% risk of infection, which is not fatal, incurred during an operation to replace the defective unit. (This assumes no risk of defects in the replacement unit.)

    Of course, this is just my simple analysis as a layperson. More significant is the statement by Dr. Maron, an expert, that he would have replaced your unit if Guidant had let him know of the defect. And beyond hypotheticals, Dr. Maron in fact performed a replacement procedure a few weeks ago on your father, who has the same genetic heart disease you did and had the same potentially defective defibrillator in his chest.

    The decisions taken by Dr. Maron, together with the statements of various other physicians quoted in the Times, strongly suggest that the letter writer above is right: Decisions about whether to replace a possibly defective defibrillator should be made by the doctor and patient, not by a paternalistic (and conflicted!) corporation.

    Incidentally, your dad is looking to hire a lawyer.


    * * *
    But we haven't finished with Guidant.

    As we said, manufacturing changes were made in 2002 to correct the flaw. Naturally, however, once Guidant began producing the improved units, they still had inventory of units made before the change.

    Surely ... surely ... the company destroyed the old units. No?

    Unfortunately, no. It seems they continued selling the old ones for months after they'd begun producing the improved units.

    This revelation prompted a new story in the Times, 9 days after the first, which reports:


    In response to questions from The New York Times, Guidant said late yesterday that it had continued to sell units out of inventory - those made before the fixes - because it believed that the devices were reliable.
    In its statement, the company said: "After making these improvements, Guidant sold product manufactured before the improvements because the reliability data showed that the original PRIZM 2 DR, like the enhanced version, was a highly reliable life-saving product. Current data continues to support the reliability of this product."

    The apparent fact that Guidant sold older devices with the potential flaw when improved ones were available could pose a new round of problems for the company. [Again -- why "apparent," even when the company has openly acknowledged its actions?!] The Food and Drug Administration is reviewing how Guidant officials handled problems related to the device.

    In addition, two plaintiffs' law firms filed an action yesterday against Guidant in Federal District Court in Indianapolis seeking damages in connection with the company's handling of the device.

    Some doctors said they would be dismayed if the company allowed them to implant a device with a known flaw that had been corrected in other units.

    "Guidant is an honorable company," said Dr. Douglas Zipes, a cardiology professor at Indiana University School of Medicine who is also a consultant to Medtronic, another defibrillator maker. "If they personally knew this device had the potential for failing, I can't imagine that they would go ahead and continue to sell it."

    [Excerpted from Heart Device Sold Despite Flaw, Data Shows, New York Times, June 2, 2005.]

    (As a further aside, the article's inclusion of the Zipes quote is bizarre. What Dr. Zipes "can't imagine" is precisely what the company was doing. Perhaps this is a tremulous reporter's way of conveying the idea that Guidant is not "an honorable company"?)


    * * *
    The same day that the first Times story on the Guidant issue appeared, I received this email message from a Dr. Steven L. Higgins, who identified himself as a "Practicing Clinical Electrophysiologist ... acting independently though I am a member of the Guidant Medical Advisory Board":


    From: Steven Higgins
    To: Uriel Wittenberg
    Sent: Tuesday, May 24, 2005 1:49 PM
    Subject: Another one today
    Hello:

    While trying to find a way to send an email to NYT writer Barry Meier, I found your website. There is another biased and potentially harmful article by this author today ([Maker of Heart Device Kept Flaw From Doctors, New York Times, May 24, 2005]). In the usual "thorough" investigation of the NY Times, Mr Meier neglected to uncover that the sole source for his story, Dr. Robert Hauser, is a former employee (President!) of the company criticized in the article (Guidant, formerly CPI). While I do not know for sure if Dr. Hauser had any ulterior motives, this certainly bears mention and investigation by this supposed investigative reporter....

    Barry Meier was the Times reporter who'd written the article. Dr. Higgins had come upon my site via my Abusing Kids for Money, a criticism of another article on an unrelated issue by the same reporter. ("This Times story, like so many others, fails to achieve the basic goal of journalism: It does not adequately inform....")

    But Dr. Higgins's assertion that Dr. Hauser had been Meier's "sole source" for the article was plainly wrong. The article quoted several physicians who appeared critical of Guidant, including Dr. Cannom, a member of Guidant's board of outside medical advisers. The article also appeared to give ample space to Dr. Smith to express the company's position.

    Dr. Higgins's claim that the Times story "neglected to uncover" that Dr. Hauser was a former employee of "Guidant, formerly CPI" and that "this certainly bears mention" was also at odds with the plain text of the article:


    Dr. Hauser, who was also involved in the treatment [of the patient who died last March], is a former chief executive of Cardiac Pacemakers Inc., one of five companies that was spun off by Eli Lilly in 1994 to form Guidant.
    My correspondent was, incidentally, the real Dr. Higgins (confirmed via a phone call to his California office receptionist).

    Who is Dr. Higgins? He is the founder (in 1989) and director of The Scripps Regional Cardiac Arrhythmia Center, in La Jolla, California, a facility described at its website as


    an international leader in the management of heart rhythm disorders (cardiac arrhythmias) [which] cares for thousands of patients every year and performs more than 1,000 arrhythmia studies annually. Highly trained cardiac specialists and surgeons have pioneered numerous techniques and innovative procedures.
    Higgins's bio at the site says:


    He has authored numerous scientific publications as well as a book, The Implantable Cardioverter Defibrillator. He has also served as a peer reviewer for five professional electrophysiology and cardiology journals and is a member of several medical advisory boards.
    There is no mention there of Higgins's financial ties to Guidant -- a relationship that appears to constitute a conflict of interest in his treatment of patients at the Scripps center.

    A statement that Higgins "serves as a consultant for several corporations, including Guidant, Medtronic, and Cardima Medical," does appear at Spotlight Health Community, a website operated by one of the organizations whose medical advisory boards Higgins serves on.

    The Spotlight Health Community homepage labels its mission as "combining healthcare expertise and celebrity experiences in a caring supportive community." In case that's unclear, it elaborates thus:


    What is Spotlight Health Community?
    Celebrities have access to the world's best doctors and the latest developments in medicine. Now we bring that same level of information and empowerment to you.

    The site enables members to set up eDiaries. The homepage currently highlights the following teaser for a "Featured eDiary":


    I had RNY in 2/00,in the past 2yrs I have gain 40+ lbs,I am miserable, very depressed and can't seem to get it togehter.I am out of control,I cry all the time.I NEED HELP! [click on link for continuation]
    The site's company info page, after noting how "We harness the magnetic attraction of celebrities' intimate personal health stories to generate strong interest, promote enhanced awareness and motivate positive behavioral change," says:


    Spotlight Health, Inc., is a private corporation funded by Prism Venture Partners and PPD, Inc. The company derives revenues from many sources, one of which is sponsorships associated with our Web site health issue communities ( please see our Sponsors and Partners page).
    Among the 5 listed sponsors is one Guidant Corp.

    Spotlight Health's bio on Dr. Higgins is less restrained than the one at the Scripps Regional Cardiac Arrhythmia Center site, asserting that he is among "the most distinguished cardiologists in the United States." It's there also that his consulting role to several corporations is noted.


    * * *
    Dr. Higgins's email message to me continued:


    The likelihood is that if the devices in question were explanted, the replacement unit would be no safer than the one removed (again due to random component failures) so the risk of the surgery would be unwarranted.
    This echoed the mystifying suggestion by Guidant's Dr. Smith that defibrillators produced after the manufacturing improvement "might not perform as well" as the old ones. But Higgins would provide no more explanation than the Times.

    Dr. Higgins's message went on to rail against the Times article:


    In the interest of creating headlines and another NYT scoop, [Times reporter] Mr. Meier has likely caused harm to innocent people. If just one patient has his device removed because of the fear generated from this article, it will be one too many. If several do, there is likely to be physical harm (not just financial) that results from Mr. Meier's shoddy reporting.
    There should be a way to make the media accountable for such harm.

    Dr. Higgins's message led to an exchange which he eventually abandoned as unsatisfactory. (Full text here.) I was not going to defend Guidant, he came to realize -- despite the facts that the Times had criticized Guidant, and I had on multiple occasions criticized the Times.

    But in the course of our correspondence, Dr. Higgins provided a remarkable letter he'd sent to his patients -- apparently a general letter addressed to all his patients with implantable defibrillators. It repeats the strange suggestion that Guidant's improved defibrillator is no better than the unimproved one, and it recommends against replacing the unimproved one, a position contrary to that of several cardiologists quoted in the Times articles:


    You may have read an inflammatory New York Times article recently....
    Although a change in manufacturing was made to make [the] problem even less likely, there is no evidence that Guidant Prizm 2 ICDs are any more susceptible to failure than any other.

    I have researched this problem in great detail. I respect my role in helping to recommend the best medical care for each of you. As a result, I am not recommending that any patient have his Prizm 2 ICD replaced prior to its elective time when the battery has depleted.

    [Excerpted from Dr. Higgins's letter to patients. ]

    In my last message to Dr. Higgins, I referred to a striking statement he'd made in one of his messages -- "I stated my bias.... I consult for Guidant" -- and asked:


    Is your advice to your patients biased? Do you not see a significant problem here?
    There's been no word since then from Dr. Higgins. He is invited to respond. (See Right of Response policy at top of urielw.com.)



    Sources include the New York Times articles: Maker of Heart Device Kept Flaw From Doctors, May 24, 2005; F.D.A. Meets With Maker of Flawed Heart Device, May 25, 2005; and Heart Device Sold Despite Flaw, Data Shows, June 2, 2005. Minor portions of the articles incorporated into text. Some quotations slightly edited.



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


    FOLLOWUP
    June 18-19, 2005

    Oh, the power of the New York Times!

    Until recently, Guidant had no intention of informing an estimated 24,000 patients (later revised to 17,000) that the Guidant-produced defibrillators they had implanted in their chests had a risk of short-circuiting -- even after the flaw led to a patient's death.

    Upon learning of an imminent Times report on the subject, however, Guidant issued an advisory. But it still treated the story as a non-issue. It advised doctors to take no action in light of the flaw, and adopted the policy that in case some patient nevertheless insisted on replacing his/her flawed unit, it would only reimburse the price of the device on a pro-rata basis, based on a 6-year device lifespan. (That at least is my guess of what the Times report means. See F.D.A. Meets With Maker of Flawed Heart Device, May 25, 2005.)

    But when the Times reports something like this, developments happen:


    The flaw discussed to date concerns the so-called Ventak Prizm 2 DR Model 1861 model. Guidant has now announced that two other models have also repeatedly short-circuited: the Contak Renewal and Contak Renewal 2, which are more complex defibrillators intended for patients with severe heart failure. In one of the cases of a Renewal malfunction, the patient died.

    Guidant says its internal testing shows that the failure rate of Renewal products might increase over time from a current rate of 0.09 percent to a range of 0.2 percent to 0.6 percent.

    Guidant is not, this time, recommending against surgery to replace these two models. It is not making a recommendation one way or the other. It is urging physicians to closely follow how well the two models are functioning. This urging is apparently purely a result of the Times's exposure of the issue. (Note that the death involving a Renewal malfunction was only reported to Guidant on May 30. But there were also 14 earlier reports of electrical failures with Renewal units.)

    About 11,900 Renewal products are currently implanted in patients worldwide.

    The Times reports that "it appears that Guidant may have continued to sell older Renewal models in its inventory after improved versions were available, as it had done with the Prizm 2 defibrillator. Yesterday [June 17], Guidant officials declined to comment about the issue." (Guidant made its manufacturing changes for the Renewal models in August, 2004.)

    Guidant has now issued a recall of all 3 models -- about 29,000 units.

    In a policy reversal, Guidant will now provide free replacement units for all 3 models.
    But what's not addressed in the news reports I've seen is the issue of other costs borne by patients or their insurers, namely, surgery and other medical service fees, and costs arising from possible complications from surgery. In cases where surgery is a result of Guidant unloading old inventory of flawed product onto unwitting patients, after it had improved units available, it could fairly be asked why Guidant shouldn't compensate for total costs, including patient inconvenience, lost time, and pain and suffering.


    Guidant has just announced that there are also problems with 4 additional defibrillator models, these in use by a further 21,000 patients. Guidant is recalling these as well. Again, this appears to be purely a result of the Times's exposure.
    The 4 models are: the Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT. The problems with these models involve programming errors which can be corrected without surgery.


    Altogether, Guidant is recalling 50,000 defibrillators.

    The F.D.A. is continuing a review of Guidant's handling of these issues.

    Tim Ulatowski, the director of the F.D.A.'s Center for Devices and Radiological Health, has publicly criticized Guidant, saying its recall should have been issued earlier.
    One news story quotes Dr. David M. Salerno, a cardiac electrophysiologist at the Chattanooga Heart Institute in Tennessee. Dr. Salerno appears to be full of compassion for Guidant Corp. while bereft of sympathy for his patients, 50 of whom reportedly have the potentially faulty defibrillators:


    I don't think every patient with one of these should panic. There's no defibrillator out there that's infallible.
    [Quoted in Guidant Recalls 50,000 Defibrillators, June 18, 2005.]

    There's the kind of scolding you'd want to hear from the physician who's implanted the faulty device in your chest: This bad news shouldn't upset you -- you weren't being very smart if you felt much better before.

    I wonder if Dr. Salerno bothers sterilizing his instruments before operating. After all, there's no way to guarantee against infection.



    Sources: Citing Flaws, Maker Recalls Heart Devices and Guidant Recalls 50,000 Defibrillators, both published in the New York Times June 18, 2005. Minor portions of the articles incorporated into text.



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


    A Diseased Democracy
    June 23, 2005


    People sometimes do bad things;

    Corporations sometimes violate ethics in pursuit of profits;

    Patients should research the manufacturer before getting a medical device implanted.
    These would be the wrong lessons to draw from the Guidant story. #1 and #2 we already knew since they're obvious, not to mention unchangeable, thus useless in teaching how to avoid such problems in future. #3 is the ugly "personal responsibility" outlook that gives the strong carte blanche to abuse the weak.

    The correct lesson here is that for democracy to function properly, the state of our civic intelligence must be improved. The legal and regulatory framework within which Guidant has operated is antisocial; harmful to the people; wrong. That is not a matter of opinion, but a matter of being informed. It's only because of our defective state of civic intelligence that politicians are able to enact unequivocally antisocial measures.

    As new information comes to light in the wake of Guidant's scandal, we learn that the workings of the free market in medical devices have been deliberately hobbled to benefit corporate lobbyists at the expense of the public interest. This is not government for the people.

    Some details:


    Congress, while allowing Medicare to spend billions of tax dollars on medical devices, effectively bars it from collecting data showing how well competing products work.

    Even as the use of expensive devices like artificial knees and defibrillators expands rapidly, patients and doctors get less information about products that are implanted in bodies than consumers get on the safety and performance of cars.

    A doctor's decision to use a particular manufacturer's artificial hip or pacemaker is often based on subjective factors. Often, physicians will choose the devices on which they were trained or ones they are used to using.
    "We are flying blind," said Dr. Robert Hauser, a cardiologist who voluntarily maintains a database where several hospitals report problems with pacemakers and defibrillators.


    Because patient records do not include the make or model of implanted devices, it's all but impossible to learn how long a product lasts or what flaws show up repeatedly. As a result, doctors often rely on reports issued by manufacturers called product performance reviews to assess devices. Such reports, experts said, suffer from numerous problems. Frequently, doctors do not send failed devices back to a manufacturer unless a patient death or injury is involved, and even then they may not do so. In addition, heart devices are typically not examined after a patient dies to see if its possible failure might have contributed to the death.

    Under little-known F.D.A. requirements, however, makers of pacemakers and defibrillators must report highly detailed product performance data to the agency once a year. But most physicians do not know that the agency collects the data because the F.D.A. has chosen not to make it public.
    An F.D.A. spokeswoman said she believed that the reports were probably available under the Freedom of Information Act, but did not say why the agency did not make the data public automatically.


    In January, Medicare expanded by one-third the number of people who could qualify for defibrillator implants, extending coverage to about 500,000 patients. As part of that initiative, the program is asking doctors and hospitals to fill out special forms to make sure that the right patients are getting the costly units and so that Medicare can tell how many people are benefiting.
    As part of the form, the agency is asking doctors for a raft of patient data, but the forms do not ask for the device's make or model.
    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)
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