A stent anecdote from a former FDA Associate Commissioner

by Peter J. Pitts

As the saying goes, the plural of anecdote isn’t data. That is unless the anecdote supports your theory. Here’s a personal anecdote — a story of how the system works.

Being adopted, I have no family history, so when I suffered through some late night chest pains I figured I’d better act on the warning signals. I called my GP and got a same-day consultation, resulting in a next-day referral to a cardiologist and a stress test. Diagnosis – arterial blockage and an immediate referral to NYU Medical Center for an angiogram. 48 hours later I had two stents and was home – writing this report.

My situation is not unique but, being in the business of healthcare policy, some of the things that happened to me are indicative of some broader themes.

1. Facts vs. fear. After being admitted into the cardiac unit, getting my wrist ID and giving some blood, my first visit was with a nurse practitioner who began her explanation of stents as follows, “You might have read some newspaper articles about how stents are over-used and dangerous. That’s crap. They save lives, they’re safe and it’s a lot more pleasant than open-heart surgery.”

This before she asked me what I did for a living.

2. The evils of pharmaceuticals. After the obligatory (and important!) lecture about the need to eat more healthfully and exercise more regularly, one of the resident’s said to me, “And we’re big believers in pharmaceutical intervention – don’t believe everything you read in the newspaper.”

This before he asked me what I did for a living.

3. Problems with the FDA. When I told the interventional cardiologist that I was a former FDA associate commissioner and was at the agency when the first drug eluting stent was approved, his comment was, “That’s something you should be proud of.”

That, despite all the middle-of-the-night poking and prodding (and my roommate’s bed-rattling basso profundo snoring) made my visit a more meaningful and memorable experience.

4. The cost of innovation. As I walked in my own front door a mere 26 hours after surgery, full of piss and vinegar and ready for action, I remembered my father. His first heart attack (at an age only slightly older than mine today) landed him in the hospital where his sternum was split open and a bypass performed. A dangerous operation followed by a lengthy hospital stay and a prolonged, home-bound period of recovery. That was then. The best there was at the time. Top-notch 20^th century surgical technique and pharmaceutical therapy. It was very expensive and left him with a scar the size and shape of a Sonoran Gopher Snake.

Over 20 years later, all I have to remember my surgery by is a small catheter incision and a handful of booklets on heart-healthy nutrition.

Which I plan to read and act on.

Tennis anyone?

Peter J. Pitts is co-founder and president of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner. He blogs at Drugwonks.

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Comments

ileana
And how would this help the public? Maybe you are more informed than the rest of us, but I think they should have come up as more helpful than “this is crap”.
How about: There are stories in newspapers that mention an over-utilization of stents: this is why you need them, here are the studies that demonstrate it’s useful in your case. Maybe what we read in the newspaper is crap, but them mentioning just that does not convince the typical layperson. It just confuses the rest of us further and it makes us trust less both the newspapers and the doctors.
Jeff Taylor
I’m glad things went well for you and hope it stays that way but as you say one anecdote does not countermand the growing body of peer-reviewed evidence about the misuse of stents.
http://ethicalnag.org/2010/09/29/cardiologists-implant-unnecessary-stents/ Carolyn Thomas
Hello Peter
I’m a tad puzzled about the purpose of your essay here. Your own anecdote, while vaguely cheerful, is hardly an example of proving that “the system works”.
The nurse practitioner who reassured you that “stents save lives” was not delivering evidence-based data to you, but it’s not unusual that you believed her anyway. At a time like this, you were no longer a former FDA heavyweight – you were a heart patient and thus easily susceptible to any glimmer of hope or reassurance.
In fact, research published in the Annals of Internal Medicine found that over 80% of heart patients who had stents implanted were like you – they believed that the procedure would cut their odds of having a future heart attack. But about the same proportion of physicians reported to researchers that they had told their patients ONLY that stents would do nothing more than relieve chest pain.
Let’s face it, stents are big business. Interventional cardiologists love them. Patients love them. Device manufacturers like Johnson & Johnson, Abbott and Boston Scientific love them because they sold over $3 billion worth of stents last year, and they have invested heavily in expanding the use of these stents. How do you expand the use of stents? You could, like the stent-happy Dr. Mark Midei of Maryland is accused of doing, implant them in patients whose coronary artery blockages are less than the 50% protocol guidelines – sometimes, allegedly, even in the 10% range.
And according to the New York Times:
“The specialists who are most likely to diagnose coronary artery disease are in many cases also the doctors who implant stents.”
And by the way, last time I checked, “crap” is not commonly accepted medicolegal terminology.
Chuck
Your dad’s bypass was done after a cardiologist who had nothing to gain from the procedure except his patient’s well-being referred him to a surgeon, who would gain monetarily, to decide if he was a candidate. The recovery may have taken long, but he did not need lifelong medication after the bypass, except to correct the factors that led to the blockages in the first place- and back then, the statins and aspirin that would keep the bypass open longer were not routinely used, leading us to say that they were good for 10 yrs.
Your getting home in 2 days to celebrate also means you haven’t seen the bill, so don’t talk about cost comparisons yet. While your dad’s surgeon may have gotten $5-10K for the operation and the hospital another $50K, your incredibly simpler procedure and shorter stay will cost probably half as much, but you probably will need Plavix for the rest of your life, and likely face at least one hospitalization resulting from bleeding complications from using it. And instead of taking $50K to pay nurses and OR staff (and pay for uninsured and poorly insured patients), the hospital will take the $25k from you to pay a stent manufacturer and their stockholders about half that money

A stent anecdote from a former FDA Associate Commissioner

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