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Cardiac Defibrillators: Is Research Supporting Their Use Tainted By Financial Interests?

I’ve been working for a couple of months on an in-depth article on personal defibrillators that are implanted beneath the skin of a person’s chest to shock a heart that starts shaking, thereby restoring its normal beating and preventing sudden death.  Discussing these defibrillators is extremely complex, which is why I am spending so much time on researching and writing the article intended to help patients and their families make an informed decision by learning the truth about the devices known as implantable cardioverter defibrillators (ICDs) — the good and the bad, your life saved vs nothing happening or the accompanying risks and harm you may receive.  So when I heard that a new study would be presented at the annual scientific meeting this week of the Heart Rhythm Society, a professional organization of cardiologists and electrophysiologists who use cardiac devices in their patients, I made sure to get an advance copy of what would be presented and interview the lead author.

Potentially such a study would be of interest to physicians and to patients considering getting an ICD because it looked at all shocks the defibrillators gave the heart in patients who took part in the clinical trial, including those sent for life-threatening rhythms and in error.  For several reasons, I felt the study is not ready to report to the public.  It is only an abstract.  The full study has not yet been written, let alone published in a peer-reviewed journal or even accepted for publication.  Patients with defibrillators who received shocks were matched to only one other patient who was not shocked, but the two patients were not matched for what other illnesses or poor quality of health they had.  Yet they were matched to see who lived the longest and the study looked at death for all causes, not just heart-related. One critical question the study sought to answer was this:  Do the shocks themselves cause a shortened life (even if they temporarily save it) or is a shortened life the result of the types of heart rhythms a person experiences?

But the thing that really slapped me in the face and gave me pause was the exchange of money.  In all stories I write on drugs or medical devices, I have begun asking the sources I quote for any conflicts of interest they have with pharmaceutical companies that make these products and I list the conflicts within or at the end of the story.

This study was funded by Boston Scientific, a pharmaceutical company that makes defibrillators.  And all eight authors of the study from different medical centers had financial ties to Boston Scientific.  All of them?

Would I be surprised if the study found that it was not the defibrillator’s shock that shortened life?  In the few write-ups that I’ve seen on this study presented Thursday, the lead author is quoted as saying that not the shock, but rather the type of rhythm is what was associated with shortened life.  This study that was able to look at shocks sent for a variety of heart rhythms and for other reasons may be a valuable study.  But I can’t help wonder, both as a journalist and as a potential patient, if the study would have been designed differently and reached any different conclusions if no money exchanged hands between a company that makes defibrillators and the eight physicians who designed the study and wrote its conclusions.  I am not making any accusation here.  I simply am saying that I am made to feel uncomfortable by the financial association of the doctors and big pharma.  Why do doctors do this? Should organized medicine and university medical centers forbid doctors who have any financial ties to a company from participating in a clinical trial of a product that company makes?  Especially if the company is funding the clinical trial?  That would eliminate a lot of doctors.  But the tide is changing and some financial arrangements once commonplace between doctors and industry are no longer allowed at some major university medical centers and everything is under more scrutiny than before.  We were discussing this matter of conflicts of interest Tuesday in a university class I teach to doctors who want to write for the public.

Both doctors and journalists should be truth seekers, and seeking the truth is best done independently.  Would the public be able to trust my long-researched piece on the truth about defibrillators if it turned out that I am being paid to write press releases for one or more of the companies that make these defibrillators?  Or if I wrote speeches for executives of these companies?  Or if I served as a consultant to the companies on public relations?  As a journalist, I could not consider receiving money from groups I write about. Why should doctors be allowed to receive money from companies who make a product they are using on patients in a clinical trial that purports to provide answers to serious questions about the product?

As I was wrestling with this issue and whether to write about why I am not writing about that study, journalists with Pro Publica published several articles on their website and with USA Today on money ties between big pharma and the Heart Rhythm Society.  See  hereherehere and here.

When I first began attending various cardiology organizations’ scientific meetings I was taken aback by the numbers of physician speakers who would begin their talks with a conflict of interest slide that stayed visible only for what seemed like one second before the speaker clicked to the next slide, visible just long enough for the audience to see there was a long list of financial ties to industry, but not long enough to read what they were.  The slides were there because the doctor organizations were requiring transparency.  But what was happening was not transparent because nobody could read what was on those slides.  How rare but heartening it was when a speaker began a talk by saying “I have no conflicts of interest.”  That is changing and more doctors are able to say they have no conflicts. But much more needs to change.

I was also amazed to see the large numbers of “non-official” scientific sessions sponsored by individual pharmaceutical companies and listed in the official scientific programs — with leading cardiologists as presenters and well attended by conference goers — that preceded the official program at these major cardiology meetings. What portion of these presentations used company slides and drove home company messages?  After seeing all this, I remember holding my breath as I asked the cardiologist I had invited to co-author a book with me about heart failure if he had any financial conflicts of interest with industry.  I felt that if he did have, I could not write the book with him.  How relieved I was when he said he did not.

Pharmaceutical industry financial relationships with individual doctors and with organizations of doctors are important to the public welfare because these relationships can influence judgment and decisions, can influence what is said and not said in writing about medical products and in speaking to and advising patients.  And that is why these relationships are important to journalists who are servants of the public.

As for my long-researched piece on defibrillators, I have found more studies to read and  a couple of new interviews to do.  I believe that this examination of the truth about defibrillators that I am writing for a well known magazine’s website will be worth reading, and once it is published there, I will reprint it here.

*This blog post was originally published at HeartSense*

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