What I Wish Clinicians Knew About Industry … and Vice Versa
Let me leap out of the frying-pan into the fire; or, out of God’s blessing into the warm sun.
Cervantes: Don Quixote. Part i. Book. iii. Chap. iv.*
I sit here writing this almost 7 years from the day that marked my transition from academic cardiologist in New York to a role in the medical device industry, eventually becoming Chief Medical Officer for Rhythm Management at Boston Scientific. Almost every day since, one or another of my colleagues (I will not call them “former colleagues”; more on that later) has asked me 1 of 2 questions: What do you miss most from clinical practice? What surprised you most about the transition? The answer to the first is easy. What I miss most are the emotional bonds I formed with patients and their family members. Clinicians are privileged to share with patients some of their most difficult, most uplifting and, ultimately, most human experiences. It was excruciatingly difficult to give that up, but I find equivalent satisfaction in the thought that, rather than serially impacting 1 patient at a time, my actions can now benefit multitudes.
The second answer is more nuanced and complex. Perhaps you will be as surprised as I was at what surprised me: I discovered that clinicians are far too cynical about how industry operates … but also that industry is far too cynical about how physicians act. In the end, the frying pan and the fire are more similar than different. Practicing physicians and employees in the medical technology industry are equally motivated by the goal of improving patient outcomes, equally challenged by the difficulty inherent in making decisions based on uncertain and imperfect data, and equally burdened by the responsibility to protect patients from harm and suffering.
I really had no right to be surprised, for my first lesson came while I was still interviewing for the job. Of all the interviews, the one that worried me the most was my interview with Dr Donald Baim, the Global Chief Medical Officer for the company. Don was a giant in the field of cardiology, memorialized after his untimely death as the “Ben Franklin of Interventional Cardiology.”1 I was probably more worried about embarrassing myself in front of Don than I was about getting the job offer. As I walked into Don’s office (and I was still walking, I had not yet taken a seat), Don looked up at me and, in his distinctive voice, said “Stein … you have no idea what a Chief Medical Officer does, do you?” So much for my hope not to be embarrassed. I acknowledged that I had no idea at all. What Don said then, and what was the point of his catechism, was this: “Your role,” he said, “is to be the voice of the patient within Boston Scientific.” He went on, “We know that you don’t know anything about business. We’ve got a lot of people here with MBAs and that’s their job. Your job is to make sure that everything that we do is focused on the needs of our patients.”
That is a lesson that I found easy to take to heart. We are a publicly traded company, and we have a fiduciary duty to our shareholders to maximize the return on their investment. But I fundamentally believe, and I have yet to meet anyone in the company who feels otherwise, that the only way to do this for the long run is always to attempt to do what is right for patients in the long run. Within months of joining the company I recommended issuing a safety alert for a device that had not yet failed in the field, based on only 2 worldwide failures of a similar device and some expedited bench testing, and the only question my CEO asked me was whether I felt certain that this was the right medical decision.2
Still, a corrosive cynicism prevails in the community. Editorialists continue writing that manufacturers of implantable devices will not develop longer-lasting batteries because increasing longevity would reduce profits. The reality is that we at Boston Scientific launched our novel ICD/CRT-D Battery Technology 8 years ago, providing as much as 2 times the usable battery capacity of certain competitive devices.3 I hope that those of you treating patients on the front lines do not take this the wrong way, but the cynicism is 2-sided. Within the company, a major concern with our improved battery longevity was how clinicians would react to the prospect of fewer generator replacement surgeries in a fee-for-service world. Would practicing electrophysiologists embrace or penalize longer-lasting devices?
We all need to recognize that we all have conflicts of interest. I recall 1 brave electrophysiologist’s disclosure at a major medical meeting a few years ago. She began a discussion of expanded indications for cardiac resynchronization therapy by stating that she had “no relationships with industry to disclose …” Rather than ending it there, as so many do, she went on “… but I do get paid for every one of these devices I implant.” We all have conflicts, some financial, some intellectual, some emotional, but it is important to recognize that we also have a much more significant commonality of interest: to do what we can to extend life and to alleviate suffering. In my experience, that commonality of interest is of paramount importance for the breathtakingly vast majority of people on both sides of the divide between clinicians and industry.
So yes, once physicians were convinced of the difference in battery longevity among implanted devices, they indeed embraced them, and other manufacturers are moving to improve the labeled longevity of their devices. That phrase, “once physicians were convinced of the difference” is the key. We are all burdened by making decisions in the face of (sometimes overwhelming) uncertainty, and we are all prisoners of our own unconscious biases and heuristics.4 We will come to different judgments and we will make decisions proven in hindsight to be wrong, as too many of our decisions ultimately will be judged. When we do, it is not that we are driven by ill intent to make consciously bad decisions at the expense of our patients. Instead, it simply reflects human fallibility.
I am not arguing against a healthy skepticism as we bridge the 2 cultures of industry and practice. Skepticism is the foundation of a scientific and analytic approach to the world around us. What I am cautioning against is letting that skepticism cross the ill-demarcated border separating it from a destructive cynicism. A reflex distrust of industry by clinicians and a reflex distrust of clinical colleagues by industry frustrate the collaborative spirit necessary to continue to advance the technologies, clinical science, and treatment paradigms needed by our patients. What do I wish that clinicians knew about industry and that industry knew about clinicians? I wish that both sides knew that we each have the same goal and vision in mind. I wish we knew that both sides need each other (this is why my clinical colleagues are still “colleagues” and not “former colleagues”). Most important, I wish we knew that our future patients need us to work together collaboratively, conscientiously, and constructively.
Dr Stein is an employee of and shareholder in Boston Scientific.
The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.
The podcast and transcript are available as an online-only Data Supplement at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIRCULATIONAHA.116.024631/-/DC1.
Circulation is available at http://circ.ahajournals.org.
↵* Although commonly attributed to Cervantes (eg, Bartlett’s familiar quotations [http://www.bartleby.com/100/733.13.html]), this is a very loose translation of the passage in the original Spanish of Don Quixote: “Y lo que sería mejor y más acertado... fuera el volvernos a nuestro lugar... dejándonos de andar de ceca en meca y de zoca en colodra, como dicen. (Parte 1ª, capítulo 18).” A closer translation is given as “and that the best and wisest thing, according to my small wits, would be for us to return home, now that it is harvest-time, and attend to our business, and give over wandering from Zeca to Mecca and from pail to bucket, as the saying is.” (http://www.spanishdict.com/answers/223797/de-la-ceca-a-la-meca-in-english)
- © 2016 American Heart Association, Inc.
- Willerson JT
- 2.↵Urgent Medical Device Correction. St. Paul, MN: Boston Scientific; 2009. http://www.bostonscientific.com/content/dam/bostonscientific/quality/documents/communication-letters/Sub%20pec%202009%20Physician%20DOCS-3990432-v1-DR_LETTER_2009-12-01_REG_CODE_89__DR_.pdf. Accessed August 4, 2016.
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