Correspondence with Dr. HigginsBelow is the complete, unedited text of my correspondence with Dr. Higgins, referred to in Heart Trouble.
From: Steven Higgins 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. The more concerning feature is the bias inherent that industry was witholding important information from the public. The truth of the matter is that no implanted device is perfect. Despite the best efforts, random component failures do occur. If everytime a rare failure occured physicians and patients were notified, there would be much more harm done due to unnecessary surgery and related risks. This has been well documented in our business (specifically the Teletronics lead issue). Companies have strict protocols on how to deal with these issues. When the problem is of a frequency where the harm that could come from the device exceeds the harm from notification and potentially reoperation, the medical community is notified. As best as I know, Guidant followed these guidelines properly. 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. In the interest of creating headlines and another NYT scoop, 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 (remember US News and World Report?) Steven L. Higgins, MD Practicing Clinical Electrophysiologist (I am acting independently though I am a member of the Guidant Medical Advisory Board)
From: Uriel Wittenberg Dear Dr. Higgins, Thanks for writing, and for noting that you're connected wtih Guidant. Your message seems to factually conflict with the article. You write:
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. The article says:
Guidant said it had changed its manufacturing processes three years ago to fix the problem. There also seems to be a conflict of judgment between Guidant and physicians who spoke with the times. You write:
When the problem is of a frequency where the harm that could come from the device exceeds the harm from notification and potentially reoperation, the medical community is notified. As best as I know, Guidant followed these guidelines properly. --whereas the article says:
The physicians say that had they known earlier, they would have replaced the unit in their patient because he was at high risk of sudden death. His death is the only one known. Finally, the article says "Guidant ... was aware of 25 other cases in which the defibrillator, a Ventak Prizm 2 Model 1861, had been affected by the same flaw." That's 25 (known) out of 24,000 people the unit is implanted in, or more than 1 in 1,000. The problems thus do not seem particularly "rare," at least to this layperson. I'd be interested in your response. Sincerely, UW
From: Steven Higgins
Your message seems to factually conflict with the article. You write: These two statements are not mutually exclusive. Even if changes were made, it does not mean that the replacement unit would be safer than the one removed. I have seen the statistics to back this statement. The Prizm 2 has one of the best records for reliability in the ICD industry.
There also seems to be a conflict of judgment between Guidant and physicians who spoke with the times. You write: Once again, not mutually exclusive. If you knew you were going to be struck by lightening by standing where you were, you would do something to prevent it, wouldn't you? However, you wouldn't save any lives by replacing 1000s of devices, with an inherent 1% operative mortality or so, to save just one life.
Finally, the article says "Guidant ... was aware of 25 other cases in which the defibrillator, a Ventak Prizm 2 Model 1861, had been affected by the same flaw." That's 25 (known) out of 24,000 people the unit is implanted in, or more than 1 in 1,000. The problems thus do not seem particularly "rare," at least to this layperson. The data is all predicated upon the random component failure rate in these highly complicated devices, typically looked at in failures per month of patient exposure. The rate you quote is less than this, I believe. These devices have a much lower random component failure rate than computers or other complex devices, thank God. If you want more precise information, contact the company, Guidant at 1-800-CARDIAC.
From: Uriel Wittenberg
Even if changes were made, it does not mean that the replacement unit would be safer than the one removed. I have seen the statistics to back this statement. I'm afraid I'm not clear on your meaning. The article says "Guidant said it had changed its manufacturing processes three years ago to fix the problem." Yet you write, "Even if changes were made...." Are you casting doubt on Guidant's assertion to the Times that a change was made? You also say "it does not mean that the replacement unit would be safer." Are you saying the change in Guidant's manufacturing processes has not resulted in safer units? I'm also confused by your response to the physicians' statements that "they would have replaced the unit in their patient because he was at high risk of sudden death." You draw a comparison to being struck by lightning, suggesting the physicians' position is based only on hindsight. Are you saying that a decision to replace the unit in THAT patient, based on knowledge of the defect in the unit, would have been unreasonable?
From: Steven Higgins Uriel: Who are you? Why the sudden interest? I must refer you to Guidant as I cannot speak on their behalf. I am an independent physician in private practice. I consult for Guidant as a member of the Medical Advisory Board when asked. Again, I refer you to them (1-800-CARDIAC) if you want answers to your questions. I did the best I could in explaining my concerns. Apparently you have a different agenda. Steven Higgins, MD
From: Uriel Wittenberg Dr. Higgins, this is rather strange. Sudden interest? Agenda? You will recall that you approached me. Til then I'd paid no particular attention to this story. You've offered several comments whose implications tend to exculpate Guidant. If you do not explain yourself, I will have to consider the possibility that *you* have an agenda. And at this point I doubt my conclusions will be charitable.
From: Steven Higgins Uriel: I still am not sure as to your motivation. I wrote to you as I thought you had an interest in exposing bias or ethical issues at the New York Times. Now, you are dissecting subtle medical details of the situation in what appears to be an attempt to support the Times or, perhaps, just assume that corporate America is always wrong. If that is the case, I don't have time to debate this matter with you. Unless I understand what motivates you and how it could help the issue, I cannot spend time explaining this complex situation. To put it bluntly, if you are a member of the media, I would be happy to discuss this situation but you must understand that I do not represent Guidant. If you are a patient, I must refer you elsewhere but would be happy to help. If you have other interests, I think it only fair that you mention them. I stated my bias in my prior correspondence. "I consult for Guidant as a member of the Medical Advisory Board when asked. Again, I refer you to them (1-800-CARDIAC) if you want answers to your questions." I will attach a letter I have written to my patients which may answer some of your questions. Steven Higgins, MD
From: Uriel Wittenberg
I thought you had an interest in exposing bias or ethical issues at the New York Times. I do.
If you have other interests, I think it only fair that you mention them. My sole interest is as a writer/commentator. I'm totally UNbiased, and by no means do I "assume that corporate America is always wrong." You say I am "dissecting subtle medical details." What is subtle about the following?
I am not recommending that any patient have his Prizm 2 ICD replaced prior to its elective time when the battery has depleted. That openly and directly conflicts with the position of Dr. David S. Cannom, who sits on Guidant's board of outside medical advisers. He 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. [quoted at http://www.finfacts.com/irelandbusinessnews/publish/article_10001915.shtml ] You write, "I stated my bias.... I consult for Guidant." Indeed the content of your communications to me suggests bias. And it is strange that you would take the initiative of approaching me about this issue, whereas Guidant itself, as yet, makes no allusion to this issue in its news releases at its website. Is your advice to your patients biased? Do you not see a significant problem here?
[The following sent after talking with Renee, who answered when I phoned Dr. Higgins's office.]
From: Uriel Wittenberg Hi Renee, This was the last message I sent to Dr. Higgins and I hadn't heard back. As mentioned, I intend to write an article on this subject and to quote Dr. Higgins's correspondence. I invite him to amplify on or clarify any of his remarks to me. Thanks, Uriel
----- Original Message ----- [correspondence history]
From: Uriel Wittenberg Dr. Higgins, I've now written my article about Guidant and yourself. It's at http://urielw.com/guidant.htm, and you are invited to respond. As I note there, any response you care to offer will appear with the article, complete and unedited. Sincerely, UW
Home > Heart Trouble |